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Subject: ***SPAM*** =?windows-1252?Q?In_House_Program-ISO_13485:2016_AWARENESS_FOR_MEDICAL_DEVICES?=

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CLICK HERE TO DOWNLOAD THE FULL BROCHURE FILE

ISO 13485:2016

AWARENESS FOR MEDICAL DEVICES

(HRDF/SBL Claimable)

TWO DAYS INHOUSE PROGRAM BY SELVA=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

=A0

TARGET GROUP (WHO SHOULD ATTEND?)=20

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

=A0

PROGRAM OBJECTIVE=20

1.To define the term Quality and Quality Management System

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

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

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

=A0

SEMINAR OBJECTIVES

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

-Define QMS and describe mandatory components of a Medical Device Quality =
Management=20
System

-Describe and interpret the general requirements of ISO 13485:2016 by =
clause

-Interpret and implement organizational risk assessment measures and =
reporting

-Interpret and implement process validation, software validation and =
sterilization=20
validation with adequate documentation

=A0

MODE OF DELIVERY:=20

POWERPOINT SLIDES, GROUP DISCUSSIONS, WORKSHOPS, QUIZ=2E

=A0

COURSE CONTENT

DAY 1

-Definition of Quality & Medical Device QMS?

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

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

-Mandatory Requirements on Documents & records

-QMS Components:

1.=A0 4.0 Quality Management System

-SOFTWARE VALIDATION [NEW!] CLAUSE 4.1.6

-APPLICATION OF RISK [NEW!] CLAUSE 4.2.1

-Medical Device File

-Quality Manual

2.=A0 5.0 Management Responsibility

-Responsibility, Authority, Communication

-Management Review

-Customer focus

Interactive Group Discussions-=20

-Application Case Study 1: Mandatory Documentation Gap Analysis

-Application Case Study 2: Management Commitment Checklist

=A0

DAY 2

-POP QUIZ and RECAP OF DAY 1!

-QMS Components:

6.0 Resource Management:

-Infrastructure

-Work Environment

-Contamination Control=20

=A0

7.0 Product Realization

-Purchasing

-Production and service provision Clause 7.5.6:=20

-Retrospective, Prospective and Concurrent Validation principles

-Validation Master Plan and What to be validated

-Sample Validation Protocol (IQ/OQ/PQ)

=A0

8.0 Measurement, Analysis & Improvement

-Complaint Handling

-Mandatory Reporting to regulatory

-Control of non-conforming

-Corrective and Preventive action=20

=A0

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

=A0

1.General requirements for risk management

2.Risk management process

-RISK ANALYSIS

-RISK EVALUATION

-RISK CONTROL

-PRODUCTION & POST PRODUCTION

INFORMATION

3.Management responsibilities

4.Qualification of personnel

5.Risk management plan

6.Risk management file

=A0

Interactive Group Discussions- Application:

-Application 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

ABOUT THE FACILITATOR

SELVA

(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=2E

=A0

=A0CLICK HERE TO DOWNLOAD THE FULL BROCHURE FILE

We hope you find it informative and interesting=A0 and we look

forward to seeing you soon=2E

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

or email to james@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

James

OTC Training Centre Sdn Bhd
Mobile No. : 012-5882263

Email address: james@otc.com.my

website:www.otc.com.my

Facebook: www.facebook.com/otcmalaysia

Linkedin =
:https://www.linkedin.com/in/otc-training-centre-sdn-bhd-5311a317a/

Instagram : otctrainingcentre_001

=93Be sure to follow my LinkedIn, Facebook and instagram page, where I =
share=20
breaking news and information=94

We Believe in connecting Knowledge...both for your People & Industry

=A0

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<!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">
<span=20
style=3D'FONT-SIZE: 26pt; FONT-FAMILY: "Arial",sans-serif; COLOR: =
#0070c0'><a=20
href=3D"https://drive.google.com/file/d/1l1atux3NfIfkLPxRG2AIEohr5ZgPNxWf/v=
iew?usp=3Dsharing"><font=20
size=3D3>CLICK HERE TO DOWNLOAD THE FULL BROCHURE =
FILE</a>
<span=20
style=3D'FONT-SIZE: 26pt; FONT-FAMILY: "Arial",sans-serif; COLOR: =
#0070c0'>ISO=20
13485:2016<?xml:namespace prefix =3D "o" ns =3D=20
"urn:schemas-microsoft-com:office:office" /><o:p></o:p>
<span=20
style=3D'FONT-SIZE: 26pt; FONT-FAMILY: "Arial",sans-serif; COLOR: =
#0070c0'>AWARENESS=20
FOR MEDICAL DEVICES<o:p></o:p>
<font=20
size=3D3>(HRDF/SBL Claimable)<o:p></o:p>
TWO=20
DAYS INHOUSE PROGRAM BY SELVA <o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>INTRODUCTION<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>Medical device =
quality=20
management system (MDQMS) is a structured system of procedures and =
processes=20
covering all aspects of design, manufacturing, supplier management, risk=20
management, complaint handling, clinical data, storage, distribution, =
product=20
labelling, and more. Most medical devices will require some form of a QMS; =
the=20
complexity of the QMS will vary based on the classification of the=20
device.<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>ISO 13485:2016 =
was=20
published in March 2016. ISO 13485:2016 specifies requirements for a =
quality=20
management system where an organization needs to demonstrate its ability =
to=20
provide medical devices and related services that consistently meet =
customer and=20
applicable regulatory requirements. Such organizations can be involved in =
one or=20
more stages of the life-cycle, including design and development, =
production,=20
storage and distribution, installation, or servicing of a medical device =
and=20
design and development or provision of associated activities (e.g. =
technical=20
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=20
management<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>TARGET GROUP =
(WHO=20
SHOULD ATTEND?) <o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>Quality =
Management=20
Representative (QMR), Middle Management (Executives, Engineers &amp;=20
Supervisors) and Manager/Head of Quality Department.<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>PROGRAM =
OBJECTIVE=20
<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>1.To define the =
term=20
Quality and Quality Management System<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>2.To interpret =
the=20
specific requirements of ISO 13485:2016 and its relevance to ISO 9001:2015 =
&amp;=20
ISO 14971.<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>3.To be able to =
apply=20
the requirements of the LATEST standard in day to day operations towards=20
compliance with the standard<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>4.To interpret =
and=20
implement new requirements on Risk Assessment, Software Validation &amp; =
Process=20
Validation.<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>SEMINAR=20
OBJECTIVES<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>At the end of =
the=20
seminar/workshop, the participants are expected to:<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-Define QMS =
and=20
describe mandatory components of a Medical Device Quality Management=20
System<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-Describe and =
interpret=20
the general requirements of ISO 13485:2016 by clause<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-Interpret and=20
implement organizational risk assessment measures and=20
reporting<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-Interpret and=20
implement process validation, software validation and sterilization =
validation=20
with adequate documentation<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>MODE OF =
DELIVERY:=20
<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>POWERPOINT =
SLIDES,=20
GROUP DISCUSSIONS, WORKSHOPS, QUIZ.<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>COURSE=20
CONTENT<o:p></o:p>

<table class=3DMsoNormalTable=20
style=3D"WIDTH: 100%; BORDER-COLLAPSE: collapse; mso-yfti-tbllook: 1184; =
mso-padding-alt: 0cm 0cm 0cm 0cm"=20
cellSpacing=3D0 cellPadding=3D0 width=3D"100%" 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: 50%; 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=3D"50%">
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>DAY=20
 1<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Definition of=20
 Quality &amp; Medical Device QMS?<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Malaysian=20
 Medical Device Regulatory Requirement [Medical Device Act 737, =
Medical=20
 Device Regulation 2012]<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-Medical =
Device=20
 Authority (MDA) MOH Conformity Assessment Requirements for Medical =
Device=20
 Premise Registration in Malaysia<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Mandatory=20
 Requirements on Documents &amp; records<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-QMS=20
 Components:<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>1.&nbsp; =
4.0=20
 Quality Management System<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-SOFTWARE=20
 VALIDATION [NEW!] CLAUSE=20
 4.1.6<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-APPLICATION OF=20
 RISK [NEW!] CLAUSE=20
 4.2.1<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-Medical =
Device=20
 File<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-Quality=20
 Manual<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>2.&nbsp; =
5.0=20
 Management Responsibility<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Responsibility,=20
 Authority, Communication<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Management=20
 Review<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Customer=20
 focus<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>Interactive Group=20
 Discussions- <o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Application Case=20
 Study 1: Mandatory Documentation Gap Analysis<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Application Case=20
 Study 2: Management Commitment Checklist<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p></td>
 <td=20
 style=3D"BORDER-TOP: windowtext 1pt solid; BORDER-RIGHT: windowtext =
1pt solid; WIDTH: 50%; 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=3D"50%">
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>DAY=20
 2<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-POP QUIZ =
and=20
 RECAP OF DAY 1!<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-QMS=20
 Components:<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>6.0 =
Resource=20
 Management:<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Infrastructure<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-Work=20
 Environment<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Contamination=20
 Control <o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>7.0 =
Product=20
 Realization<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Purchasing<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Production and=20
 service provision Clause 7.5.6: <o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Retrospective,=20
 Prospective and Concurrent Validation =
principles<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Validation=20
 Master Plan and What to be validated<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-Sample=20
 Validation Protocol (IQ/OQ/PQ)<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>8.0 =
Measurement,=20
 Analysis &amp; Improvement<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Complaint=20
 Handling<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Mandatory=20
 Reporting to regulatory<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-Control =
of=20
 non-conforming<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Corrective and=20
 Preventive action <o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Introduction to=20
 Risk Management ISO 14971 &amp; Application of Concepts <span=20
 style=3D"COLOR: red">[NEW!]<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>1.General=20
 requirements for risk management<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>2.Risk =
management=20
 process<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-RISK=20
 ANALYSIS<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-RISK=20
 EVALUATION<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>-RISK=20
 CONTROL<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-PRODUCTION &amp;=20
 POST PRODUCTION<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>INFORMATION<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>3.Management=20
 responsibilities<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>4.Qualification=20
 of personnel<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>5.Risk =
management=20
 plan<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>6.Risk =
management=20
 file<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>Interactive Group=20
 Discussions- Application:<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>-Application Case=20
 Study 3: Application of Risk Management To Manufacturing Process =
[Clauses=20
 6.2, 7.1 AND 4.2.1]<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>POST =
TRAINING=20
 WRITTEN ASSESSMENT [1.0 HOUR: MCQ AND SHORT ANSWER=20
 QUESTIONS]<o:p></o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
 <span=20
 style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p></td></tr></table>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>ABOUT THE=20
FACILITATOR<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'>SELVA<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>(HRDF TTT CERT =
No:=20
9391)<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>ASQ Certified =
Quality=20
Auditor, CQA (Cert No: 67568)<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>ASQ Certified=20
Pharmaceutical GMP Professional (Cert No: 434)<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>IFSTC Certified =
ACB-GMP=20
Auditor (Cert No: ACB-GMP-2017-04) <o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>Principal=20
Consultant/Trainer <o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>Mr. Selva is a=20
consultant, assessor and trainer. He brings along with him a wealth of=20
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.<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>Selva has =
strong=20
exposure in quality management systems, quality tools development, =
training=20
needs analysis (HRDF approved Lead TNA Consultant), and soft skills such =
as=20
business communication skills.&nbsp; As such, he is well trained on areas =
such=20
as Quality, Quality System Tools, Internal auditing skills, SOPs writing, =
Good=20
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 &amp; Best =
Warehouse=20
Practices (BWP). He has also worked on numerous projects related to =
HIRADC=20
(Hazard Identification, Risk Assessment, Determination of Control) and=20
increasing safety awareness among employees in an organization.&nbsp;=20
<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>He has worked =
with=20
several multinationals on training and consultancy related short and long =
terms=20
projects. Some of the esteemed clients that he has served are STANLEY=20
ENGINEERING SDN BHD, PRENT MALAYSIA SDN BHD, HACKS MALAYSIA, LUCAS =
AUTOMOTIVE=20
SDN BHD, NORIPHARMA SDN BHD, SEE SEN CHEMICALS, IDAMAN PHARMA, PERITONE =
HEALTH=20
SDN BHD, EDMARK INDUSTRIES SDN BHD, NORIPHARMA SDN BHD, IDAMAN PHARMA SDN =
BHD,=20
HERBAL SCIENCE SDN BHD, EVERBEST SOYA BEAN PRODUCTS AND TECK LEE SENG =
COFFEE SDN=20
BHD.<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>Having served =
various=20
multinational corporations, SG carries with him the expertise of QC =
Executive,=20
QC Microbiologist, Senior QA Executive, QA &amp; EHS Manager and QA =
Manager. His=20
expertise spans over several types of industries that includes =
pharmaceuticals,=20
food, tobacco, health supplements, printing, calcium carbonate, =
industrial=20
chemicals and automotive.<o:p></o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: =
"Arial",sans-serif'><o:p>&nbsp;</o:p>
<span=20
style=3D'FONT-SIZE: 12pt; FONT-FAMILY: "Arial",sans-serif'>He received =
his=20
tertiary education for his Bachelor's degree majoring in Microbiology =
from=20
National University of Malaysia (or known as UKM). He is ASQ Certified=20
Pharmaceutical GMP Professional (CPGP). He had also completed a =
Certificate in=20
Quality Engineering (CQE) recognised by American Society for Quality (ASQ) =
and=20
an Executive Diploma in Health &amp; Safety Management. He is also a ASQ=20
Certified Quality Auditor (CQA). He is also MOH FSQ Certified ACB-GMP =
Auditor=20
for Food. Certified as =93National Industry Expert for Pharma &amp; Med =
Devices=94=20
by the Department of Competency Development under Ministry of Human =
Resources=20
Malaysia . He had also completed Food Safety Handler Training provider =
course=20
with Ministry of Health (MOH) or referred as =93Kursus Wajib Tenaga =
Pengajar=20
Latihan Pengendali Makanan KKM=94. He is also a Certified Lead Auditor for =
ISO=20
9001:2015 and ISO 13485:2016 for medical devices.<o:p></o:p>
<o:p>&nbsp;</o:p>
<font=20
size=3D3>&nbsp;<a=20
href=3D"https://drive.google.com/file/d/1l1atux3NfIfkLPxRG2AIEohr5ZgPNxWf/v=
iew?usp=3Dsharing">CLICK=20
HERE TO DOWNLOAD THE FULL BROCHURE FILE</a>
We hope you find =
it=20
informative and interesting&nbsp; and we=20
look<o:p></o:p>
forward to seeing =
you=20
soon.<o:p></o:p>
<font=20
size=3D3>Please act fast to grab your favorite =
training=20
program! Please call 012-588 2263<o:p></o:p>
<font=20
size=3D3 face=3DCalibri>or email to <a>james@otc.com.my</a><o:p></o:p>
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style=3D"COLOR: #c00000"><o:p>&nbsp;</o:p>
<span=20
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<font=20
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<span=20
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Email=20
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