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ISPE GAMP® Basic Principles Training
OVERVIEW
This classroom course has been updated to include the new revised GAMP® 5 Second Edition.
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
COURSE MODULES
- Introduction
- Regulations and Regulators
- Requirements of 21 CFR Part 11
- Overview of GAMP® 5
- GAMP® 5 Lifecycle in Detail
- Regulated Company and Supplier Activities
- Quality Risk Management and Detailed Risk
- Testing
- Operational Phases
- Effective and Efficient Compliance
WHO SHOULD ATTEND
- Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance and regulations.
- Computer system vendors or consultants, engineering contractors, and validation service companies.
LEARNING OBJECTIVES:
- Explain the regulatory requirements and expectations for computerized systems used in pharmaceutical manufacturing
- Apply GAMP® principles to specific systems and cases
- Describe the GAMP® approach to computerized system compliance
- Apply these ideas to systems within your own organization
COMMUNITY OF PRACTICE (COP)
This training course is of particular interest to existing and future members of the ISPE GAMP® Community of Practice (COP)
Led by:
David Margetts, CEO, Factorytalk Co., Ltd., Thailand
David Margetts is the CEO of Factorytalk, and an advisor, consultant, and technical expert in the areas of compliance and information technology. David’s background and experience span a wide range of IT solutions for GxP applications, from shop floor systems to the corporate level in the pharmaceutical, biotechnology, and ATMP industries. Before moving to Asia in 2004 to help start Factorytalk, he worked in engineering and validation for Industrial Technology Systems Ltd., in engineering roles for AstraZeneca PLC ,and he is the former Managing Director of Asia for Werum/Koerber Pharma. David is active in ISPE as a certified trainer for computer validation and in Pharma 4.0™ and its Validation 4.0 group. He is both responsible to lead the company and manage critical client assignments for large Pharma MNCs and leading regional manufactures. He has been an ISPE member since 2004.
Registration fees:
Member
US$ 895 / SGD 1,195
Non-ISPE Member
US$ 1,095 / SGD 1,485
Government / Academia / Emerging Economies
US$ 550 / SGD 735
| Member | US$ 895 / SGD 1,195 |
| Non-ISPE Member | US$ 1,095 / SGD 1,485 |
| Government / Academia / Emerging Economies | US$ 550 / SGD 735 |