관리-도구

편집 파일: 1629435340.M856421P20405.server.saraya-global.com,S=91968,W=94054:2,

Envelope-to: zakri@saraya.com.my
Delivery-date: Fri, 20 Aug 2021 12:55:40 +0800
Organization: OTC
Message-ID: <7f04b7cb7a53d867137a543b00375774@otcsb.com.my>
From: "grace@otcsb.com.my" <grace@otcsb.com.my>
To: "HI SIR/MADAM," <grace@otcsb.com.my>
Date: Fri, 20 Aug 2021 11:38:01 +0800
MIME-Version: 1.0
Content-Type: multipart/alternative;
	boundary="f676a8fcda08bd61469e80b00018eb85"
 
 Content analysis details: (6.5 points, 5.0 required)
 pts rule name description
 ---- ---------------------- --------------------------------------------------
 1.0 BAYES_999 BODY: Bayes spam probability is 99.9 to 100%
 [score: 1.0000]
 5.0 BAYES_99 BODY: Bayes spam probability is 99 to 100%
 [score: 1.0000]
 -0.0 SPF_PASS SPF: sender matches SPF record
 0.5 SUBJ_ALL_CAPS Subject is all capitals
 0.0 HTML_FONT_LOW_CONTRAST BODY: HTML font color similar or
 identical to background
 0.0 HTML_MESSAGE BODY: HTML included in message
 0.0 T_KAM_HTML_FONT_INVALID Test for Invalidly Named or Formatted
 Colors in HTML
X-Spam-Flag: YES
Subject: ***SPAM*** =?windows-1252?Q?LIVE_ONLINE_PROGRAM_=96_ISO_13485:2016_AWARENESS_FOR_MEDICAL_DEVICES_(06_=96_07_OCT_2021)?=

--f676a8fcda08bd61469e80b00018eb85
Content-Type: text/plain;
	charset="windows-1252"
Content-Transfer-Encoding: quoted-printable

LIVE ONLINE PROGRAM

ISO 13485:2016=20

AWARENESS FOR MEDICAL DEVICES=20

Venue : Online Training (Via Zoom)=A0=A0 =
=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0(HRDF/SBL Khas =
Claimable)

Date : 06 Oct2021 (Wed)=A0 |=A0 9am =96 =
5pm=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0 =A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0By =
Selva

07 Oct 2021 (Thu) |=A0 9am =96 5pm=A0=A0=A0=A0=A0 =
=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0.=A0 =A0

=2E=A0=A0=20

=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0 =A0.=A0=A0=20

INTRODUCTION:

Medical device quality management system (MDQMS) is a structured system =
of=20
procedures and processes covering all aspects of design, manufacturing, =
supplier=20
management, risk management, complaint handling, clinical data, storage, =
distribution,=20
product labelling, and more. Most medical devices will require some form =
of=20
a QMS; the complexity of the QMS will vary based on the classification of =
the=20
device=2E

=A0

ISO 13485:2016 was published in March 2016. ISO 13485:2016 specifies =
requirements=20
for a quality management system where an organization needs to =
demonstrate=20
its ability to provide medical devices and related services that =
consistently=20
meet customer and applicable regulatory requirements. Such organizations =
can=20
be involved in one or more stages of the life-cycle, including design and =
development,=20
production, storage and distribution, installation, or servicing of a =
medical=20
device and design and development or provision of associated activities =
(e.g.=20
technical support). The ISO 13485 standard is an effective solution to =
meet=20
the comprehensive requirements for a quality management system (QMS). =
Adopting=20
ISO 13485 provides a practical foundation for manufacturers to address =
the=20
regulations and responsibilities as well as demonstrating a commitment to =
the=20
safety and quality of medical devices. ISO 13485:2016 can also be used by =
suppliers=20
or external parties that provide product, including quality management =
system-related=20
services to such organizations.=20

=A0=A0

PROGRAM OBJECTIVE:

1.=A0=A0=A0=A0=A0=A0 To define the term Quality and Quality Management =
System

2.=A0=A0=A0=A0=A0=A0 To interpret the specific requirements of ISO =
13485:2016 and its relevance=20
to ISO 9001:2015 & ISO 14971=2E

3.=A0=A0=A0=A0=A0=A0 To be able to apply the requirements of the LATEST =
standard in day=20
to day operations towards compliance with the standard

4.=A0=A0=A0=A0=A0=A0 To interpret and implement new requirements on Risk =
Assessment, Software=20
Validation & Process Validation=2E

=A0=A0=20

SEMINAR OBJECTIVE:

At the end of the seminar/workshop, the participants are expected to:

1.=A0=A0=A0=A0=A0=A0 Define QMS and describe mandatory components of a =
Medical Device Quality=20
Management System

2.=A0=A0=A0=A0=A0=A0 Describe and interpret the general requirements of =
ISO 13485:2016=20
by clause

3.=A0=A0=A0=A0=A0=A0 Interpret and implement organizational risk =
assessment measures and=20
reporting

4.=A0=A0=A0=A0=A0=A0 Interpret and implement process validation, software =
validation and=20
sterilization validation with adequate documentation

=A0

TARGET GROUP:

Quality Management Representative (QMR), Middle Management (Executives, =
Engineers=20
& Supervisors) and Manager/Head of Quality Department=2E

=A0

MODE OF DELIVERY:

Powerpoint Slide, Group Discussions, Workshops, Quiz=2E

=A0=A0

OUTLINE OF WORKSHOP

Day 1 (9.00am - 5.00am)=A0

-=A0Definition of Quality & Medical Device QMS?

-=A0Malaysian Medical Device Regulatory Requirement [Medical Device Act =
737,=20
Medical Device Regulation 2012]

-=A0Medical Device Authority (MDA) MOH Conformity Assessment Requirements =
for=20
Medical Device Premise Registration in Malaysia

-=A0Mandatory Requirements on Documents & records

-=A0QMS Components:

4.0 Quality Management System

-=A0SOFTWARE VALIDATION [NEW!] CLAUSE 4.1.6

-=A0APPLICATION OF RISK [NEW!] CLAUSE 4.2.1

-=A0Medical Device File

-=A0Quality Manual

5.0 Management Responsibility

-=A0Responsibility, Authority, Communication

-=A0Management Review

-=A0Customer focus

Interactive Group Discussions-=20

-=A0Application Case Study 1: Mandatory Documentation Gap Analysis

Application Case Study 2: Management Commitment Checklist

=A0

Day 2 (9.00am - 5.00am)=A0=A0

-=A0POP QUIZ and RECAP OF DAY 1!

-=A0QMS Components:

6.0 Resource Management:

-=A0Infrastructure

-=A0Work Environment

-=A0Contamination Control=20

=A0

7.0 Product Realization

-=A0Purchasing

-=A0Production and service provision Clause 7.5.6:=20

a. Retrospective, Prospective and Concurrent Validation principles

b. Validation Master Plan and What to be validated

c.=A0Sample Validation Protocol (IQ/OQ/PQ)

=A0

8.0 Measurement, Analysis & Improvement

-=A0Complaint Handling

-=A0Mandatory Reporting to regulatory

-=A0Control of non-conforming

-=A0Corrective and Preventive action=20

=A0

-=A0Introduction to Risk Management ISO 14971 & Application of Concepts =
[NEW!]

=A0

1.=A0 General requirements for risk management

2.=A0 Risk management process

-=A0RISK ANALYSIS

-=A0RISK EVALUATION

-=A0RISK CONTROL

-=A0PRODUCTION & POST PRODUCTION INFORMATION

3. Management responsibilities

4. Qualification of personnel

5. Risk management plan

6. Risk management file

=A0

Interactive Group Discussions- Application:

-=A0Application Case Study 3: Application of Risk Management To =
Manufacturing=20
Process [Clauses 6.2, 7.1 AND 4.2.1]

=A0

POST TRAINING WRITTEN ASSESSMENT [1.0 HOUR: MCQ AND SHORT ANSWER QUESTIONS]

=A0

** Digital Certificate of attendance will be awarded for those who =
completed=20
the course

=A0

ABOUT THE FACILITATOR=20

=A0

Mr. Selva=20

=A0

(HRDF TTT CERT No: 9391)

ASQ Certified Quality Auditor, CQA (Cert No: 67568)

ASQ Certified Pharmaceutical GMP Professional (Cert No: 434)

IFSTC Certified ACB-GMP Auditor (Cert No: ACB-GMP-2017-04)=20

Principal Consultant/Trainer=20

=A0

Mr. Selva is a consultant, assessor and trainer. He brings along with him =
a=20
wealth of experience in various fields including development, =
implementation=20
and consulting for Quality Management Systems (ISO 9001:2015 & ISO =
13485:2016),=20
Food Safety Management (ISO 22000 & HACCP & GMP) and Laboratory Quality =
Management=20
System (ISO/IEC 17025:2017) in both Chemistry and Microbiology Labs. He =
also=20
carries numerous experience in implementation and sustaining Good =
Manufacturing=20
Practices Standard or known commonly as GMP (PIC/S, WHO & TGA) for =
pharmaceutical=20
and food industries=2E

=A0

Selva has strong exposure in quality management systems, quality tools =
development,=20
training needs analysis (HRDF approved Lead TNA Consultant), and soft =
skills=20
such as business communication skills.=A0 As such, he is well trained on =
areas=20
such as Quality, Quality System Tools, Internal auditing skills, SOPs =
writing,=20
Good Manufacturing Practices (GMP), Process Failure Mode Effects Analysis =
(PFMEA),=20
HACCP, SWOT analysis, Good Laboratory Practices (GLP) and other =
corresponding=20
programs such as Customer Satisfaction Surveys Management & Best =
Warehouse=20
Practices (BWP). He has also worked on numerous projects related to =
HIRADC=20
(Hazard Identification, Risk Assessment, Determination of Control) and =
increasing=20
safety awareness among employees in an organization.=A0=20

=A0

He has worked with several multinationals on training and consultancy =
related=20
short and long terms projects. Some of the esteemed clients that he has =
served=20
are STANLEY ENGINEERING SDN BHD, PRENT MALAYSIA SDN BHD, HACKS MALAYSIA, =
LUCAS=20
AUTOMOTIVE SDN BHD, NORIPHARMA SDN BHD, SEE SEN CHEMICALS, IDAMAN PHARMA, =
PERITONE=20
HEALTH SDN BHD, EDMARK INDUSTRIES SDN BHD, NORIPHARMA SDN BHD, IDAMAN =
PHARMA=20
SDN BHD, HERBAL SCIENCE SDN BHD, EVERBEST SOYA BEAN PRODUCTS AND TECK LEE =
SENG=20
COFFEE SDN BHD=2E

=A0

Having served various multinational corporations, SG carries with him the =
expertise=20
of QC Executive, QC Microbiologist, Senior QA Executive, QA & EHS Manager =
and=20
QA Manager. His expertise spans over several types of industries that =
includes=20
pharmaceuticals, food, tobacco, health supplements, printing, calcium =
carbonate,=20
industrial chemicals and automotive=2E

=A0

He received his tertiary education for his Bachelor's degree majoring in =
Microbiology=20
from National University of Malaysia (or known as UKM). He is ASQ =
Certified=20
Pharmaceutical GMP Professional (CPGP). He had also completed a =
Certificate=20
in Quality Engineering (CQE) recognised by American Society for Quality =
(ASQ)=20
and an Executive Diploma in Health & Safety Management. He is also a ASQ =
Certified=20
Quality Auditor (CQA). He is also MOH FSQ Certified ACB-GMP Auditor for =
Food.=20
Certified as =93National Industry Expert for Pharma & Med Devices=94 by =
the Department=20
of Competency Development under Ministry of Human Resources Malaysia . He =
had=20
also completed Food Safety Handler Training provider course with Ministry =
of=20
Health (MOH) or referred as =93Kursus Wajib Tenaga Pengajar Latihan =
Pengendali=20
Makanan KKM=94. He is also a Certified Lead Auditor for ISO 9001:2015 and =
ISO=20
13485:2016 for medical devices.=A0

=A0

(HRDF/SBL Khas Claimable)

=A0

=A0EARLY BIRD Fee  =20

NORMAL FEE

Registration before

23 Sep 2021  =20

RM 1,270.00/pax

(Subject to 6% SST)  =20

Registration after

23 Sep 2021  =20

RM 1,320.00/pax

(Subject to 6% SST)

Group Registration: Register 3 participants from the same organization, =
the=20
4th participant is FREE.=20
(Buy 3 Get 1 Free) if Register before 23 Sep 2021. Please act fast to =
grab=20
your favourite training program!
        =20

=A0

PLEASE FEEL FREE TO CONTACT ME IF YOU ARE LOOKING FOR THE FULL BROCHURE =
FILE

We hope you find it informative and interesting and we look

forward to seeing you soon=2E

Please act fast to grab your favorite training program! Pleasecall =
012-588=20
2263

or email to grace@otc.com.my

=A0

Do forward this email to all your friends and colleagues who might be =
interested=20
to attend these programs

=A0

If you would like to unsubscribe from our email list at any time, please =
simply=20
reply to the e-mail and type=20

Unsubscribein the subject area. We will remove your name from the list =
and=20
you will not receive any additional e-mail

=A0

Thanks

=A0

Regards

=A0

OTC Training Centre Sdn Bhd
=A0

--f676a8fcda08bd61469e80b00018eb85
Content-Type: text/html;
	charset="windows-1252"
Content-Transfer-Encoding: quoted-printable

<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN">
<html>
<head>
<meta content=3D"text/html; charset=3D" http-equiv=3D"content-type">
</head>
<body style=3D"FONT-SIZE: 10pt; FONT-FAMILY: Tahoma, Tahoma">
LIVE=20
ONLINE PROGRAM<?xml:namespace=20
prefix =3D "o" ns =3D "urn:schemas-microsoft-com:office:office"=20
/><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 28pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
blue; mso-ansi-language: EN-US'>ISO=20
13485:2016 <o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 24pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
blue; mso-ansi-language: EN-US'>AWARENESS=20
FOR MEDICAL DEVICES <span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 14pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>Venue=20
: Online Training (Via Zoom)&nbsp;&nbsp; <span=20
style=3D"COLOR: =
#0d0d0d">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;=
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;=
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
red; mso-ansi-language: EN-US'>(HRDF/SBL=20
Khas Claimable)<o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 14pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>Date=20
: 06 Oct 2021 (Wed)&nbsp; |&nbsp; =
9am =96=20
5pm<span=20
style=3D"COLOR: =
#0d0d0d">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;=
=20
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;By=
=20
Selva<o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 14pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
#0d0d0d; mso-ansi-language: EN-US'>07=20
Oct 2021=20
(Thu) |&nbsp; 9am =96 5pm<span=20
style=3D"COLOR: #0d0d0d">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;=20
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nb=
sp;&nbsp;&nbsp;&nbsp;&nbsp;<span=20
style=3D"COLOR: white">&nbsp;.&nbsp; &nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 14pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
white; mso-ansi-language: EN-US'>.&nbsp;&nbsp;=20
<o:p></o:p>
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&n=
bsp;&nbsp;&nbsp;&nbsp;=20
&nbsp;.&nbsp;&nbsp;=20
<o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>INTRODUCTION:<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
Medical=20
device quality management system (MDQMS) is a structured system of =
procedures=20
and processes covering all aspects of design, manufacturing, supplier=20
management, risk management, complaint handling, clinical data, storage,=20
distribution, product labelling, and more. Most medical devices will =
require=20
some form of a QMS; the complexity of the QMS will vary based on the=20
classification of the device.<span=20
style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
black'><o:p></o:p>
&nbsp;<span=20
style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
black'><o:p></o:p>
ISO=20
13485:2016 was=20
published in March 2016. ISO 13485:2016 specifies requirements for =
a=20
quality management system where an organization needs to demonstrate its =
ability=20
to provide medical devices and related services that consistently meet =
customer=20
and applicable regulatory requirements. Such organizations can be involved =
in=20
one or more stages of the life-cycle, including design and development,=20
production, storage and distribution, installation, or servicing of a =
medical=20
device and design and development or provision of associated activities =
(e.g.=20
technical support). The ISO 13485 standard is an effective solution to =
meet the=20
comprehensive requirements for a quality management system (QMS). Adopting =
ISO=20
13485 provides a practical foundation for manufacturers to address the=20
regulations and responsibilities as well as demonstrating a commitment to =
the=20
safety and quality of medical devices. ISO 13485:2016 can also be used by=20
suppliers or external parties that provide product, including quality =
management=20
system-related services to such organizations. <span=20
style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
black'><o:p></o:p>
&nbsp;<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>PROGRAM=20
OBJECTIVE:<o:p></o:p>
1.<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 7pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;=20
To=20
define the term Quality and Quality Management System<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
2.<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 7pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;=20
To=20
interpret the specific requirements of ISO 13485:2016 and its relevance to =
ISO=20
9001:2015 &amp; ISO 14971.<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
3.<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 7pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;=20
To=20
be able to apply the requirements of the LATEST standard in day to day=20
operations towards compliance with the standard<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
4.<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 7pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;=20
To=20
interpret and implement new requirements on Risk Assessment, Software =
Validation=20
&amp; Process Validation.<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
&nbsp;<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;=20
<o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>SEMINAR=20
OBJECTIVE:<o:p></o:p>
At=20
the end of the seminar/workshop, the participants are expected =
to:<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
1.<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 7pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;=20
Define=20
QMS and describe mandatory components of a Medical Device Quality =
Management=20
System<o:p></o:p>
2.<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 7pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;=20
Describe=20
and interpret the general requirements of ISO 13485:2016 by =
clause<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
3.<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 7pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;=20
Interpret=20
and implement organizational risk assessment measures and =
reporting<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
4.<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 7pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;=20
Interpret=20
and implement process validation, software validation and sterilization=20
validation with adequate documentation<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>TARGET=20
GROUP:<o:p></o:p>
Quality=20
Management Representative (QMR), Middle Management (Executives, Engineers =
&amp;=20
Supervisors) and Manager/Head of Quality Department.<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>MODE=20
OF DELIVERY:<o:p></o:p>
Powerpoint=20
Slide, Group Discussions, Workshops, Quiz.<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
&nbsp;&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
OUTLINE=20
OF WORKSHOP<o:p></o:p>
<div align=3Dcenter>
<table class=3DMsoNormalTable=20
style=3D"BORDER-COLLAPSE: collapse; mso-yfti-tbllook: 1184; =
mso-padding-alt: 0cm 0cm 0cm 0cm"=20
cellSpacing=3D0 cellPadding=3D0 border=3D0>
 =20
 <tr style=3D"mso-yfti-irow: 0; mso-yfti-firstrow: yes; mso-yfti-lastrow: =
yes">
 <td=20
 style=3D"BORDER-TOP: windowtext 1pt solid; BORDER-RIGHT: windowtext =
1pt solid; WIDTH: 490pt; BORDER-BOTTOM: windowtext 1pt solid; =
PADDING-BOTTOM: 0cm; PADDING-TOP: 0cm; PADDING-LEFT: 5.4pt; BORDER-LEFT: =
windowtext 1pt solid; PADDING-RIGHT: 5.4pt; BACKGROUND-COLOR: =
transparent"=20
 vAlign=3Dtop width=3D653>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: blue; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>Day=20
 1 (9.00am - 5.00am)&nbsp;<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>Definition=20
 of Quality &amp; Medical Device QMS?<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>Malaysian=20
 Medical Device Regulatory Requirement [Medical Device Act 737, =
Medical=20
 Device Regulation 2012]<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>Medical=20
 Device Authority (MDA) MOH Conformity Assessment Requirements for =
Medical=20
 Device Premise Registration in Malaysia<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>Mandatory=20
 Requirements on Documents &amp; records<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>QMS=20
 Components:<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>4.0=20
 Quality Management System<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>SOFTWARE=20
 VALIDATION [NEW!]=20
 CLAUSE 4.1.6<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>APPLICATION=20
 OF RISK [NEW!]=20
 CLAUSE 4.2.1<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>Medical=20
 Device File<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>Quality=20
 Manual<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>5.0=20
 Management Responsibility<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: =
EN-GB'>Responsibility,=20
 Authority, Communication<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>Management=20
 Review<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>Customer=20
 focus<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>Interactive=20
 Group Discussions- <span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>Application=20
 Case Study 1: Mandatory Documentation Gap Analysis<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 Application=20
 Case Study 2: Management Commitment Checklist<span=20
 style=3D"FONT-SIZE: 10pt"><o:p></o:p>
 &nbsp;<span=20
 style=3D"FONT-SIZE: 10pt"><o:p></o:p>
 <span=20
 lang=3DEN-US=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%; mso-ansi-language: =
EN-US'>&nbsp;<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p></td>
 <td=20
 style=3D"BORDER-TOP: windowtext 1pt solid; BORDER-RIGHT: windowtext =
1pt solid; WIDTH: 460.6pt; BORDER-BOTTOM: windowtext 1pt solid; =
PADDING-BOTTOM: 0cm; PADDING-TOP: 0cm; PADDING-LEFT: 5.4pt; BORDER-LEFT: =
#f0f0f0; PADDING-RIGHT: 5.4pt; BACKGROUND-COLOR: transparent"=20
 vAlign=3Dtop width=3D614>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: blue; LINE-HEIGHT: 150%; mso-ansi-language: EN-GB'>Day=20
 2 (9.00am - 5.00am)&nbsp;&nbsp;<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 150%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>POP=20
 QUIZ and RECAP OF DAY 1!<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>QMS=20
 Components:<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>6.0=20
 Resource Management:<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: =
EN-GB'>Infrastructure<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>Work=20
 Environment<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>Contamination=20
 Control <span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: =
EN-GB'>&nbsp;<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>7.0=20
 Product Realization<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: =
EN-GB'>Purchasing<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>Production=20
 and service provision Clause 7.5.6: <span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>a.=20
 Retrospective, Prospective and Concurrent Validation=20
 principles<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>b.=20
 Validation Master Plan and What to be validated<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>c.<span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>Sample=20
 Validation Protocol (IQ/OQ/PQ)<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: =
EN-GB'>&nbsp;<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>8.0=20
 Measurement, Analysis &amp; Improvement<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>Complaint=20
 Handling<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>Mandatory=20
 Reporting to regulatory<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>Control=20
 of non-conforming<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>Corrective=20
 and Preventive action <span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: =
EN-GB'>&nbsp;<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>Introduction=20
 to Risk Management ISO 14971 &amp; Application of Concepts=20
 [NEW!]<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: =
EN-GB'>&nbsp;<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>1.&nbsp;=20
 General requirements for risk management<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>2.&nbsp;=20
 Risk management process<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>RISK=20
 ANALYSIS<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>RISK=20
 EVALUATION<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>RISK=20
 CONTROL<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>PRODUCTION=20
 &amp; POST PRODUCTION INFORMATION<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>3.=20
 Management responsibilities<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>4.=20
 Qualification of personnel<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>5.=20
 Risk management plan<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>6.=20
 Risk management file<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: =
EN-GB'>&nbsp;<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>Interactive=20
 Group Discussions- Application:<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DX-NONE=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: X-NONE'>-<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'>&nbsp;<span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: EN-GB'>Application=20
 Case Study 3: Application of Risk Management To Manufacturing =
Process=20
 [Clauses 6.2, 7.1 AND 4.2.1]<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 <span=20
 lang=3DEN-GB=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%; mso-ansi-language: =
EN-GB'>&nbsp;<span=20
 style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
COLOR: black; LINE-HEIGHT: 115%'><o:p></o:p>
 POST=20
 TRAINING WRITTEN ASSESSMENT [1.0 HOUR: MCQ AND SHORT ANSWER=20
 QUESTIONS]<o:p></o:p>
 &nbsp;<span=20
 style=3D"FONT-SIZE: 10pt"><o:p></o:p>
 &nbsp;<span=20
 style=3D"FONT-SIZE: =
10pt"><o:p></o:p></td></tr></table></div>
&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
**=20
Digital Certificate of attendance will be awarded for those who completed =
the=20
course<o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
black; mso-ansi-language: EN-US'>&nbsp;<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New =
Roman",serif'><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
black; mso-ansi-language: EN-US'>ABOUT=20
THE FACILITATOR <span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New =
Roman",serif'><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
black; mso-ansi-language: EN-US'>&nbsp;<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New =
Roman",serif'><o:p></o:p>
Mr.=20
Selva <o:p></o:p>
&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 11.5pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>(HRDF=20
TTT CERT No: 9391)<o:p></o:p>
ASQ=20
Certified Quality Auditor, CQA (Cert No: 67568)<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
ASQ=20
Certified Pharmaceutical GMP Professional (Cert No: 434)<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
IFSTC=20
Certified ACB-GMP Auditor (Cert No: ACB-GMP-2017-04) <span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 11.5pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>Principal=20
Consultant/Trainer <o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 11.5pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 11.5pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>Mr.=20
Selva is a consultant, assessor and trainer. He brings along with him a =
wealth=20
of experience in various fields including development, implementation and=20
consulting for Quality Management Systems (ISO 9001:2015 &amp; ISO =
13485:2016),=20
Food Safety Management (ISO 22000 &amp; HACCP &amp; GMP) and Laboratory =
Quality=20
Management System (ISO/IEC 17025:2017) in both Chemistry and Microbiology =
Labs.=20
He also carries numerous experience in implementation and sustaining Good=20
Manufacturing Practices Standard or known commonly as GMP (PIC/S, WHO =
&amp; TGA)=20
for pharmaceutical and food industries.<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 11.5pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 11.5pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>Selva=20
has strong exposure in quality management systems, quality tools =
development,=20
training needs analysis (HRDF approved Lead TNA Consultant), and soft =
skills=20
such as business communication skills.&nbsp; As such, he is well trained =
on=20
areas such as Quality, Quality System Tools, Internal auditing skills, =
SOPs=20
writing, Good Manufacturing Practices (GMP), Process Failure Mode Effects=20
Analysis (PFMEA), HACCP, SWOT analysis, Good Laboratory Practices (GLP) =
and=20
other corresponding programs such as Customer Satisfaction Surveys =
Management=20
&amp; Best Warehouse Practices (BWP). He has also worked on numerous =
projects=20
related to HIRADC (Hazard Identification, Risk Assessment, Determination =
of=20
Control) and increasing safety awareness among employees in an=20
organization.&nbsp; <o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 11.5pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 11.5pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>He=20
has worked with several multinationals on training and consultancy related =
short=20
and long terms projects. Some of the esteemed clients that he has served =
are=20
STANLEY ENGINEERING SDN BHD, PRENT MALAYSIA SDN BHD, HACKS MALAYSIA, =
LUCAS=20
AUTOMOTIVE SDN BHD, NORIPHARMA SDN BHD, SEE SEN CHEMICALS, IDAMAN PHARMA,=20
PERITONE HEALTH SDN BHD, EDMARK INDUSTRIES SDN BHD, NORIPHARMA SDN BHD, =
IDAMAN=20
PHARMA SDN BHD, HERBAL SCIENCE SDN BHD, EVERBEST SOYA BEAN PRODUCTS AND =
TECK LEE=20
SENG COFFEE SDN BHD.<o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 11.5pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 11.5pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>Having=20
served various multinational corporations, SG carries with him the =
expertise of=20
QC Executive, QC Microbiologist, Senior QA Executive, QA &amp; EHS Manager =
and=20
QA Manager. His expertise spans over several types of industries that =
includes=20
pharmaceuticals, food, tobacco, health supplements, printing, calcium =
carbonate,=20
industrial chemicals and automotive.<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 11.5pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 11.5pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>He=20
received his tertiary education for his Bachelor's degree majoring in=20
Microbiology from National University of Malaysia (or known as UKM). He is =
ASQ=20
Certified Pharmaceutical GMP Professional (CPGP). He had also completed a=20
Certificate in Quality Engineering (CQE) recognised by American Society =
for=20
Quality (ASQ) and an Executive Diploma in Health &amp; Safety Management. =
He is=20
also a ASQ Certified Quality Auditor (CQA). He is also MOH FSQ Certified =
ACB-GMP=20
Auditor for Food. Certified as =93National Industry Expert for Pharma =
&amp; Med=20
Devices=94 by the Department of Competency Development under Ministry of =
Human=20
Resources Malaysia . He had also completed Food Safety Handler Training =
provider=20
course with Ministry of Health (MOH) or referred as =93Kursus Wajib =
Tenaga=20
Pengajar Latihan Pengendali Makanan KKM=94. He is also a Certified Lead =
Auditor=20
for ISO 9001:2015 and ISO 13485:2016 for medical devices.&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 20pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
blue; mso-ansi-language: EN-US'>(HRDF/SBL=20
Khas Claimable)<o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
blue; mso-ansi-language: EN-US'>&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<div align=3Dcenter>
<table class=3DMsoNormalTable=20
style=3D"WIDTH: 506.15pt; BORDER-COLLAPSE: collapse; mso-yfti-tbllook: =
1184; mso-padding-alt: 0cm 0cm 0cm 0cm"=20
cellSpacing=3D0 cellPadding=3D0 width=3D675 border=3D0>
 =20
 <tr style=3D"HEIGHT: 17.1pt; mso-yfti-irow: 0; mso-yfti-firstrow: yes">
 <td=20
 style=3D"BORDER-TOP: #a6a6a6 1pt solid; HEIGHT: 17.1pt; BORDER-RIGHT: =
#bebebe 1pt solid; WIDTH: 266.25pt; BACKGROUND: #ceddea; BORDER-BOTTOM: =
#a6a6a6 1pt solid; PADDING-BOTTOM: 2.9pt; PADDING-TOP: 2.9pt; =
PADDING-LEFT: 2.9pt; BORDER-LEFT: #a6a6a6 1pt solid; PADDING-RIGHT: =
2.9pt"=20
 width=3D355 colSpan=3D2>
 &nbsp;<span=20
 lang=3DEN-US=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
TEXT-TRANSFORM: uppercase; COLOR: black; mso-ansi-language: EN-US'>EARLY=20
 BIRD Fee<o:p></o:p></td>
 <td=20
 style=3D"BORDER-TOP: #a6a6a6 1pt solid; HEIGHT: 17.1pt; BORDER-RIGHT: =
#a6a6a6 1pt solid; WIDTH: 239.9pt; BACKGROUND: #ceddea; BORDER-BOTTOM: =
#a6a6a6 1pt solid; PADDING-BOTTOM: 2.9pt; PADDING-TOP: 2.9pt; =
PADDING-LEFT: 2.9pt; BORDER-LEFT: #f0f0f0; PADDING-RIGHT: 2.9pt"=20
 width=3D320 colSpan=3D2>
 NORMAL=20
 FEE<o:p></o:p></td></tr>
 <tr style=3D"HEIGHT: 26.4pt; mso-yfti-irow: 1">
 <td=20
 style=3D"BORDER-TOP: #f0f0f0; HEIGHT: 26.4pt; BORDER-RIGHT: #a6a6a6 =
1pt solid; WIDTH: 148.5pt; BORDER-BOTTOM: #a6a6a6 1pt solid; =
PADDING-BOTTOM: 2.9pt; PADDING-TOP: 2.9pt; PADDING-LEFT: 2.9pt; =
BORDER-LEFT: #a6a6a6 1pt solid; PADDING-RIGHT: 2.9pt; BACKGROUND-COLOR: =
transparent"=20
 width=3D198>
 Registration=20
 before<o:p></o:p>
 23=20
 Sep 2021<o:p></o:p></td>
 <td=20
 style=3D"BORDER-TOP: #f0f0f0; HEIGHT: 26.4pt; BORDER-RIGHT: #bebebe =
1pt solid; WIDTH: 117.75pt; BORDER-BOTTOM: #a6a6a6 1pt solid; =
PADDING-BOTTOM: 2.9pt; PADDING-TOP: 2.9pt; PADDING-LEFT: 2.9pt; =
BORDER-LEFT: #f0f0f0; PADDING-RIGHT: 2.9pt; BACKGROUND-COLOR: =
transparent"=20
 width=3D157>
 RM=20
 1,270.00/pax<o:p></o:p>
 (Subject=20
 to 6% SST)<span=20
 style=3D"FONT-SIZE: 10pt"><o:p></o:p></td>
 <td=20
 style=3D"BORDER-TOP: #f0f0f0; HEIGHT: 26.4pt; BORDER-RIGHT: #bebebe =
1pt solid; WIDTH: 131.2pt; BORDER-BOTTOM: #a6a6a6 1pt solid; =
PADDING-BOTTOM: 2.9pt; PADDING-TOP: 2.9pt; PADDING-LEFT: 2.9pt; =
BORDER-LEFT: #f0f0f0; PADDING-RIGHT: 2.9pt; BACKGROUND-COLOR: =
transparent"=20
 width=3D175>
 Registration=20
 after<o:p></o:p>
 23=20
 Sep 2021<o:p></o:p></td>
 <td=20
 style=3D"BORDER-TOP: #f0f0f0; HEIGHT: 26.4pt; BORDER-RIGHT: #a6a6a6 =
1pt solid; WIDTH: 108.7pt; BORDER-BOTTOM: #a6a6a6 1pt solid; =
PADDING-BOTTOM: 2.9pt; PADDING-TOP: 2.9pt; PADDING-LEFT: 2.9pt; =
BORDER-LEFT: #f0f0f0; PADDING-RIGHT: 2.9pt; BACKGROUND-COLOR: =
transparent"=20
 width=3D145>
 RM=20
 1,320.00/pax<o:p></o:p>
 (Subject=20
 to 6% SST)<span=20
 style=3D"FONT-SIZE: 10pt"><o:p></o:p></td></tr>
 <tr style=3D"HEIGHT: 30.55pt; mso-yfti-irow: 2">
 <td=20
 style=3D"BORDER-TOP: #f0f0f0; HEIGHT: 30.55pt; BORDER-RIGHT: #a6a6a6 =
1pt solid; WIDTH: 506.15pt; BORDER-BOTTOM: #a6a6a6 1pt solid; =
PADDING-BOTTOM: 2.9pt; PADDING-TOP: 2.9pt; PADDING-LEFT: 2.9pt; =
BORDER-LEFT: #a6a6a6 1pt solid; PADDING-RIGHT: 2.9pt; BACKGROUND-COLOR: =
transparent"=20
 width=3D675 colSpan=3D4>
 Group=20
 Registration: Register=20
 3 participants from the same organization, the 4th participant is =
FREE.=20
 (Buy 3 Get 1 Free) if Register =
before 23=20
 Sep 2021. Please act fast to grab your favourite =
training=20
 program!<span=20
 style=3D"FONT-SIZE: 10pt; LINE-HEIGHT: =
110%"><o:p></o:p></td></tr>
 <tr style=3D"mso-yfti-irow: 3; mso-yfti-lastrow: yes">
 <td=20
 style=3D"BORDER-TOP: #f0f0f0; BORDER-RIGHT: #f0f0f0; WIDTH: 148.5pt; =
BORDER-BOTTOM: #f0f0f0; PADDING-BOTTOM: 0cm; PADDING-TOP: 0cm; =
PADDING-LEFT: 0cm; BORDER-LEFT: #f0f0f0; PADDING-RIGHT: 0cm; =
BACKGROUND-COLOR: transparent"=20
 width=3D198></td>
 <td=20
 style=3D"BORDER-TOP: #f0f0f0; BORDER-RIGHT: #f0f0f0; WIDTH: 117.75pt; =
BORDER-BOTTOM: #f0f0f0; PADDING-BOTTOM: 0cm; PADDING-TOP: 0cm; =
PADDING-LEFT: 0cm; BORDER-LEFT: #f0f0f0; PADDING-RIGHT: 0cm; =
BACKGROUND-COLOR: transparent"=20
 width=3D157></td>
 <td=20
 style=3D"BORDER-TOP: #f0f0f0; BORDER-RIGHT: #f0f0f0; WIDTH: 131.25pt; =
BORDER-BOTTOM: #f0f0f0; PADDING-BOTTOM: 0cm; PADDING-TOP: 0cm; =
PADDING-LEFT: 0cm; BORDER-LEFT: #f0f0f0; PADDING-RIGHT: 0cm; =
BACKGROUND-COLOR: transparent"=20
 width=3D175></td>
 <td=20
 style=3D"BORDER-TOP: #f0f0f0; BORDER-RIGHT: #f0f0f0; WIDTH: 108.75pt; =
BORDER-BOTTOM: #f0f0f0; PADDING-BOTTOM: 0cm; PADDING-TOP: 0cm; =
PADDING-LEFT: 0cm; BORDER-LEFT: #f0f0f0; PADDING-RIGHT: 0cm; =
BACKGROUND-COLOR: transparent"=20
 width=3D145></td></tr></table></div>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 10pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<a=20
name=3D_Hlk61620322>&nbsp;
</a><a=20
name=3D_Hlk72477746>PLEASE =
FEEL FREE TO=20
CONTACT ME IF YOU ARE LOOKING FOR THE FULL BROCHURE=20
FILE</a><a name=3D_Hlk61620322><span=20
lang=3DEN-US><o:p></o:p></a>
We=20
hope you find it informative and interesting and we =
look<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
forward=20
to seeing you soon.<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>Please=20
act fast to grab your favorite training program! Please call =
012-588=20
2263<o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; =
mso-ansi-language: EN-US'>or=20
email to <a=20
href=3D"mailto:jgrace@otc.com.my">grace@otc.com.my</a><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
red; mso-ansi-language: EN-US'>&nbsp;<span=20
style=3D"FONT-SIZE: 10pt"><o:p></o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
red; mso-ansi-language: EN-US'>Do=20
forward this email to all your friends and colleagues who might be =
interested to=20
attend these programs=20
<o:p></o:p>
<o:p>&nbsp;</o:p>
<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
#c00000; mso-ansi-language: EN-US'>If=20
you would like to unsubscribe from our email list at any time, please =
simply=20
reply to the e-mail and type <o:p></o:p>
Unsubscribe<span=20
lang=3DEN-US=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Times New Roman",serif; COLOR: =
#c00000; mso-ansi-language: EN-US'>=20
in the subject area. We will remove your name from the list and you will =
not=20
receive any additional e-mail<o:p></o:p>
<o:p>&nbsp;</o:p>
<o:p>&nbsp;</o:p>
<o:p>&nbsp;</o:p>
<font=20
face=3DCalibri>Thanks<o:p></o:p>
<o:p>&nbsp;</o:p>
<font=20
face=3DCalibri>Regards<o:p></o:p>
<font=20
face=3DCalibri>&nbsp;
<span=20
lang=3DEN-US style=3D"COLOR: black; mso-ansi-language: EN-US">OTC Training =
Centre=20
Sdn Bhd &nbsp;

</body>
</html>

--f676a8fcda08bd61469e80b00018eb85--