Process Validations Trainer: Mr. Vincent Cheung
Process validation is an integral part of design control process, contract manufacturing and are regulatory requirements. Participants will learn “how-to” design/prepare for process validation studies, write validation test protocols/reports including the use of risk-based sample size determination for simulated processes, use of statistical software (Minitab®) for analysis and interpretation of data, handling of unanticipated deviations, and good documentation practices. Participants will also learn common mistakes, pitfalls, and consequences when a production process is not properly validated before use.
Day 1
Regulatory requirements (21 CFR Part 820, ISO 13485)
Industry practices
Sample size determination
Statistical techniques
Acceptance criteria
Common mistakes
Day 2
Performance Qualification (PQ)
Statistical data analysis (Minitab)
Handling of deviations
Good documentation practices
Common mistakes
1) Personnel from finished product manufacturers interested in bringing a new or modified medical device to market.
2) Personnel from contract manufacturers interested in or currently involved in the manufacturing of medical devices for multinational product owners. Typical job functions include but not limited to:
Manufacturing Engineering
Process Engineering
Equipment Engineering
Quality Engineering
Available Workshops:
Please contact AQS Labs.
Workshop Fee: