Preparing for Cleaning Validation Audits and Regulatory Inspections
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Destin A. LeBlanc Biography>>>
Available Live On-Demand
Audits (internal or third party) and regulatory inspections are important confirmations and/or challenges to a cleaning validation program. While the most important element of preparation is to have designed and carried out science- and risk-based cleaning process and cleaning validation practices, how that information is organized and presented may help in communicating to auditors and inspectors. This webinar will present tips for making that preparation more effective.
- Review the major concerns that auditors/inspectors might have.
- Learn how to review documents for third person clarity.
- Learn about obtaining specific inspector concerns.
- Learn how to deal with known concerns in an audit/inspection.
- Learn about responding to an auditor/inspector during the audit and following the audit.
Webinar outline and time breakdown:Time*
|9:15 AM||Log In Period|
|09:40 AM||Types of audits and inspection,|
|Reviewing past audits/inspections,|
|Common major audit/inspection concerns,|
|Getting advance information on past inspections,|
|10:40 AM||Performing a pre-inspection audit,|
|Dealing with known concerns,|
|Responding in an audit/inspection,|
|What regulatory documents say about these issues,|
|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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