COMPUTERIZED SYSTEM VALIDATION

NUSAGE – PharmEng
Pharmaceutical and Biotechnology
Training Program

www.NUSAGE.nus.edu.sg | Copyright © 2014 NUSAGE-PharmEng.

Shaping Human Capital for
Challenges in the Pharmaceutical
Industry

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 COMPUTERIZED SYSTEM VALIDATION
Objective
To learn to establish validation programs; acquire understanding of the regulatory requirements
and expectations for the validation of computer systems used in pharmaceutical and biological
industry; learn and understand the process and methodologies on computer system validation
and be able to apply the knowledge and principles to specific systems and cases.

Description
This course is designed to provide an overview of the various aspects of computer systems
validation and related validation documents and to provide the basis for compliance and
implementation. The course addresses the rules, tools, and techniques to develop and
implement a validation program or to validate a specific system. The course provides the
principles for computer validation and offers a framework and the methodologies to conduct
validation projects.

The emphasis is on the most recent rules and techniques focusing in the relevant regulations, the
system life cycle including requirements, design/build, testing, qualifications and maintenance,
21 CFR Part 11 Electronic Records and Electronic Signatures and the journey this regulation has
taken, vendor audit, acquired and developed systems, retrospective validation, validation
master plan, the validation project, risk assessment and management, SOPs, requirements
documentation, the traceability matrix, and related FDA Guidance documents.

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 COMPUTERIZED SYSTEM VALIDATION
Course Details

Instructor:

Harpreet Walia

Mr. Walia has over 20 years of experience in Pharmaceutical/Biotech industry including Project Management
and Implementation of various computerized systems. He is a Subject Matter Expert in Systems Validation, Data
Integrity, Commissioning and Qualification. He has accomplished troubleshooting of state of the art Laboratory
equipment such as HPLC, GC, Mass Spec, ICP-MS, DSC, TGA, Dissolution, Spectrophotometer, meter, Automated
Titrators and plate readers. He has validated/qualified Analyst, Millennium/Empower, Masslynx, Breeze,
Winchrome Chemstation/Chemstore softwares to meet 21CFR part 11 requirements including hands-on
experience of configuring and administration. He has setup and configured network according to user
requirements and business needs. Mr. Walia is a Waters certified “Validation/Compliance Specialist” and
“Service engineer”. He was also awarded Certificate of Excellence for best customer support.

Date and Time:

2019 (refer to website www.pharmeng.asia for latest dates)

Course Outline

• Validation Overview • Retrospective Validation

• Regulations and Regulators • Spreadsheet Validation
• GAMP (Good Automated • SOPs and Training
Manufacturing Practices) • Case Studies - Validation Requirements for
• Qualifications, IQ/OQ/PQ • Applicative Software
• 21 CFR, 11 Electronic Records and • Automated Spreadsheet Calculation
Electronic Signatures Templates
• Risk Assessment and Management • Computerized Equipment
• The System Life Cycle and Validation • Computerized Laboratory Systems
Strategies (LIMS, Chromatography Systems)
• Vendor Audit • MRP and ERP Systems
• Validation Plan and Project Management • Automated Control and Monitoring Systems
• Computer Network Qualification
Learning Outcome

Upon completion of this course the attendees will be able to:

1. Understand the various regulations and guidelines from regulatory bodies and industrial bodies such as
21 CFR 11, GAMP, Annex 11
2. Understand all the elements in a System Life Cycle approach
3. Understand the different classifications and types of computer systems, from the simple GAMP Class 1
systems to complex, bespoke Class 5 systems; from personal computer-based systems to industrial PLC
systems.

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 COMPUTERIZED SYSTEM VALIDATION

Course Registration
To register for this course or for any other course enquiries, please contact:

Ms CHEW Ying Ying

Senior Manager
Office: S4A 03
Tel: 65168977

Email: [email protected]

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 ABOUT THE TRAINING PROVIDER
PHARMENG TECHNOLOGY

PharmEng Technology (“PharmEng”), a division of PEPharma Inc., provides professional development and
certification training programs throughout North America and Asia. We deliver over 35 courses to the
pharmaceutical, biotechnology, nutraceutical and medical devices industries in the areas of:

 cGMPs
 Validation
 Engineering
 Project Management
 Medical Devices
 Quality Compliance
 Quality Assurance
 Regulatory Affairs
 Manufacturing

Why PharmEng Professional Training?

 Unique curriculum that covers key areas critical to the success of the industry, through courses that
integrate theory and practice
 Advisory committee that includes members from industry, academia and government, ensuring that
important regulatory and industry issues are addressed
 Custom courses that cover both general and basic “know-how” as well as current challenges, issues
and new developments in the industry
 Instructors that have been selected among industry leaders and subject experts who will provide
challenging course work and valuable hands-on experience

PharmEng delivers courses to two distinct groups:

1. Corporate Training: Experienced industry professionals who require current best practices in order to
keep up-to-date with industry standards, Good Manufacturing Practices (GMP’s) and regulations.

2. Career Training: Next generation individuals seeking careers in the industry who need practical skills
and “know-how” for the pharmaceutical and biotechnology workforce.

For those individuals requiring one day professional development programs, courses are available through
any of the PharmEng offices located throughout North America and Asia with access to course listings,
course availability and registration through the PharmEng website www.pharmeng.com.

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 ABOUT THE TRAINING PROVIDER
Certification Programs

For career training and certification, PharmEng offers programs through national and internationally-
recognized universities delivering certificate programs such as:

The Biopharmaceutical Technology Certificate Program for the University of Waterloo and the National Tsing
Hua University College of Life Science in Taiwan

The Biotechnology and Pharmaceutical Technology Program for Cape Breton University

Instructors and Course Materials

All instructors are subject matter experts with direct industry experience. Instructors include guest speakers
from industry, government and academia. Course materials are developed by PharmEng in-house and are
constantly updated to keep current with the regulatory environment. As the industry changes, so do the
issues and challenges.

Our courses, with supporting materials, link together:

 Training
 Regulations
 Government
 Industry
 Academia
 International Standards

Conferences

PharmEng offers conferences throughout the year in collaboration with Health Canada, and various
professional associations in biotechnology, pharmaceutical, medical devices, nutraceutical and healthcare
industries.

“Best instructor and best coverage “It was a nice change that the
of this subject that I’ve experienced instructor had personal
yet. Great session – so glad I came.” experience that I could relate to.”
- IMRIS Inc. - Medicure Inc.

“…good course, especially the case studies.”

- Genesys Venture Inc.

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 ABOUT THE TRAINING PROVIDER
PHARMENG CORE TRAINING COURSES

Current Good Manufacturing Practices Quality and Compliance Medical Devices

• GMP – Get More Productivity PharmEng® also provides customized • Medical Device Regulatory
• GMP – Concepts and Good Laboratory Practices (GLP) and Requirements
Implementation Good Clinical Practices (GCP) training to • Quality System Requirements – ISO
• cGMP’s for Drugs and Active clients in order to assist companies in 13485
Pharmaceutical Ingredients moving forward with their pre-clinical and • Quality Systems for Medical Devices
Manufacturers clinical trials.
• Master Plan – Roadmap to Manufacturing
cGMP training is tailored to meet your Compliance
company’s specific needs in one or all of • Good Laboratory Practices (GLP) • Manufacturing Control in the
the following areas: • Pharmaceutical Quality Assurance Pharmaceutical Related Industries
• Engineering and Control • Pharmaceutical and Biotech
• Production • GMP Programs – Planning and Manufacturing Processes
• Packaging Implementation • Active Pharmaceutical Manufacturing
• Quality Assurance • Audit Programs and Annual Review • Solid and Semi-Solid Dosage
• Quality Control • Recall and Compliant Systems Manufacturing
• Regulatory Affairs • Standard Operating Procedures • Aseptic Manufacturing
• Clinical Research • Corrective and Preventative Actions • Sterile and Septic Processes
• New Drug Submission/Application (CAPA)
• Natural Health Products • Risk-based Approach to Inspecting Engineering
• Active Pharmaceutical Ingredients Quality Systems
• Medical Devices • Commissioning and Validation of
• Blood and Blood Products Validation Pharmaceutical and Biotechnology
• Practical cGMP Facilities
• Analytical Methods Validation • Design and Validation of Critical Utility
Regulatory Affairs • Process Validation Systems
• Cleaning Validation • Process Analytical Technology (PAT)
• Good Clinical Practices (GCP) • Computer Systems Validation • Design and Commissioning and
• New Drug Application/Submission • Validation of Sterilization Processes Validation of
• Chemistry, Manufacturing and • Pharmaceutical and Biotechnology
Control Project Management Facilities
• Natural Health Products Registration
• Project Management in a Regulatory
Environment
• Project Management for Clinical
Research Studies

PharmEng Technology, a division of PE Pharma Inc., headquartered in Toronto, Canada, is a full-service consulting company that serves
the pharmaceutical and biotechnology industries internationally. Consulting services include project management, engineering, cGMP,
validation, calibration, regulatory compliance and certified training.

www.pharmeng.com | Copyright © 2014 NUSAGE-PharmEng.

www.NUSAGE.nus.edu.sg | Copyright © 2014 NUSAGE-PharmEng.