PDA Israel Chapter together with PDA Europe is bringing the internationally acclaimed expert on cleaning validation Mr Destin LeBlanc to Israel to give a two day course on current approaches to cleaning validation. Bearing in mind the current revisions to the EU GMPs pertaining to the use of shared facilities and the Health Based Exposure Limits draft guidance this is a genuine opportunity to come up to speed on a critical topic that is of relevance to every pharma, API and biotech company.
Course Program
| Day 1 |
- Introduction (overview and definitions)
- Application of the FDA Process Validation Guidance to Cleaning Validation
- Basic Carryover Calculations (with Variations)
- “Stratified Sampling” for Determining Protocol Compliance
- Use of Health-based Limits (Risk-MaPP and EMA)
- Use of Analytical Methods throughout the Validation Lifecycle
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| Day 2 |
- Product and Equipment Grouping Strategies
- Issues in Sampling Recovery Studies
- PAT (Process Analytical Technology) for Cleaning Processes
- Effective Validation Maintenance Techniques (including yearly re-evaluation)
- Investigating a Cleaning Failure (includes OOS)
- Microbial Issues in Cleaning Validation (includes clean hold time)
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Target Audience
This course is suitable for any person involved in cleaning validation which covers a broad variety of disciplines:
R&D personnel developing processes including cleaning processes, engineering designing “cleanable” equipment and facilities, CIP / COP systems; operations personnel involved in performing or supervising cleaning performance; QA, QC personnel, validation personnel, personnel developing analytical methods for the cleaning validation, purchasing personnel who select / change cleaning agents and tools and HR personnel involved in selecting cleaners or outsourcing this critical operation.
Destin A. LeBlanc
Destin LeBlanc consults in the area of cleaning validation as Cleaning Validation Technologies. He has extensive experience in product development and technical service for cleaning and antimicrobial applications. He has lectured on issues related to contamination control internationally, and has written widely on cleaning validation issues. He is the author of four books: Validated Cleaning Technologies for Pharmaceutical Manufacturing and Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing (Volumes 1, 2 and 3). He maintains the web site www.cleaningvalidation.com as a resource for cleaning validation professionals. He is a member of PDA and ISPE, and regularly trains FDA personnel on cleaning validation. He was co-chair for PDA’s Technical Report #49 (Points to Consider for Biotechnology Cleaning Validation) and chair for the 2012 revision of PDA’s Technical Report #29 (Points to Consider for Cleaning Validation). He is a graduate of the University of Michigan and the University of Iowa.
Participation Fees:
Members: 4200 NIS
Non Members: 5400 NIS
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