Explore How the New FDA Process Validation Guidance Will Affect Cleaning Validation & Strategies for Simplifying Cleaning Validation Based on Principles in the FDA Document Validation
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Destin LeBlanc Biography>>>
Available Live On-Demand
The January 2011 finalized FDA Process Validation guidance redefines expectations for process validation. That guidance does not formally apply to cleaning processes, but cleaning processes can be considered a subset, albeit a specialized subset, of manufacturing process that the guidance could address.
This live training webinar is designed to provide an introductory review of the FDA Process Validation Guidance, and address how the principles of that document might be applied in a cleaning validation program. It will discuss what aspects of the document are not meaningful when applied to a cleaning process. Furthermore, strategies for simplifying cleaning validation, based on principles in the FDA document, will also be covered. The implications for cleaning validation programs will be discussed, particularly items that may help in efforts to streamline validation programs based on good science and a revised approach. This includes the possibility of reducing the number of validation runs required. Application of these principles will help provide robust and meaningful strategies for designing and improving cleaning validation programs.
-Understanding the basics of the new FDA Process Validation Guidance.
-Learning differences and similarities of process validation and cleaning validation.
-Applying principles in the FDA Guidance to cleaning validation programs in a meaningful way.
-Understanding what principles or expectations for process validation do not apply and are not meaningful for cleaning validation.
-Learning when to apply statistics to a cleaning validation program.
-Avoiding dogma unsupported by science and logic.
Webinar outline and time breakdown:Time*
|9:15 AM||Log In Period|
|09:40 AM||Redefinition of “Validation”,|
|Stage 1 Issues (Design and Development),|
|Stage 2 Issues (Qualification Protocols),|
|10:40 AM||Stage 3 Issues (Maintenance of the Validated State),|
|Strategies for Incorporating Principles in Cleaning validation Programs,|
|Application of Statistics to Cleaning Validation,|
|11:30 AM||Live Questions & Discussion|
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of training for attendee records
Who should attend:
This live training webinar is applicable to drug product manufacturers and API manufacturers, including biopharmaceutical manufacturers. The following individuals or disciplines involved in process equipment cleaning validation will benefit from attending this live webinar:
- Microbiology personnel
- Senior management responsible for cleaning validation
- Validation, Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, Technical Support
- Directors, Managers/Supervisors, Scientists, Technicians, Operators, Auditors
- Regulatory Affairs Professionals
Instructor: Destin LeBlanc
Destin LeBlanc has over twenty-five years of Technical Service and Product Development experience in specialty chemicals and medical technologies, the last ten of which have been involved with various aspects of cleaning and cleaning validation in pharmaceutical and medical device manufacturing.
Destin LeBlanc consults in the area of cleaning validation as Cleaning Validation Technologies. Previously, he had been with STERIS/Calgon Vestal for over twenty years, primarily 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 two books Validated Cleaning Technologies for Pharmaceutical Manufacturing, Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing- Volume 1 and Cleaning Validation: Practical Compliance Solutions for... Full Bio>>>
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