Designing and Implementing a Lifecycle Approach for Cleaning Validation

Live, Interactive Training Webinar

Date: Thursday February 28, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc Biography>>>

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Design/development and validation maintenance has always been part of what pharmaceutical companies do for cleaning validation. Now there is an increasing trend to make a lifecycle approach part of a formal cleaning validation program. This has been accelerated by the publication of the 2011 FDA Process Validation guidance, as well as documents from other regulatory agencies and from ICH. While the FDA guidance does not formally apply to the validation of cleaning processes, other regulatory documents include cleaning processes within the purview of a lifecycle approach.

This live webinar is designed to provide an introductory review of the lifecycle principles in various regulatory documents, focusing on the FDA Process Validation Guidance. It then discusses how the principles of lifecycle validation might be applied in a cleaning validation program. It will also cover some principles typically applied in a process validation program that might not apply to a cleaning validation program. Furthermore, strategies for simplifying cleaning validation based on lifecycle principles will also be covered, including strategies to streamline cleaning validation programs based on good science and appropriate risk assessments. This includes the possibility of reducing the number of validation runs required and of moving “worst case” evaluations to the design/development phase. Application of these lifecycle principles will help provide robust and meaningful strategies for designing and improving cleaning validation programs.



Learning Benefits:
- Clarify what dedication means.
- Explore options for validating dedicated equipment.
- Clarify the nature of campaigns.
- Learn how to deal with “minor” cleaning within a campaign.
- Explore options for campaign length.
- Learn how regulatory documents address these issues.

Webinar outline and time breakdown:

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Defining dedication,
Why dedicate equipment,
Setting limits for dedicated equipment,
What regulatory documents say about dedication?,
11:30 AM Break
11:40 AM Defining campaigns,
Determining appropriate campaign length,
Effects of “minor” cleaning in a campaign,
Special issues in campaign validation,
Extending the campaign length Training issues for operators,
What regulatory documents say about campaigns?,
12:30 PM 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

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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>>>

 

Course Number: 251

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland