Cleaning Validation; Utilizing “Health-Based” Limits, Toxicological Evaluation VS. Dose-Base Criterion, Examination of ISPE Approach and EMA’s New Dedication Guidance

Live, Interactive Training Webinar

Date: Tuesday September 24, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc Biography>>>

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The issue of setting limits for process equipment cleaning validation was initially settled in 1993 by reference in the FDA cleaning validation guidance to the Fourman/Mullen paper on how limits were set for drug product manufacture at Lilly. This was expanded later in the 1990’s by the PIC/S guidance regarding certain more hazardous actives. With the publication of ISPE’s Risk-MaPP (2010) and the EMA’s 2012 draft guidance on dedicated facilities, a scientific debate has been opened on appropriate ways to set limits for cleaning validation.

On one side are scientists who maintain that all limits should be based on a thorough toxicological evaluation (an ADE per Risk-MaPP or a PDE per EMA). On the other side are scientists who maintain that the dose-based criterion is more than adequate for most actives that are not highly hazardous, but that the ADE/PDE approach provides an additional option to dedicated facilities/equipment for actives which are highly hazardous. Most scientists are in the middle, unclear about what direction to go.

This live training webinar will explore the background of both the ISPE and EMA approaches, critique their suggested applications, and suggest ways to move forward.

Learning Benefits:
-Understanding the rationale for setting limits.
-Exploring how limits have been set in past.
-Differing ways to address highly hazardous and non-highly hazardous actives.
-Rationales for dedicated vs. non-dedicated facilities.
-Understand what Risk-MaPP is.
-Learn concerns about Risk-MaPP.
-Understand what EMA’s “Dedication” guidance is.
-Learn concerns about EMA’s “Dedication” guidance.
-Explore options to consider going forward.

Webinar outline and time breakdown:

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions and Regulatory Status,
Basis of Dose-Based Calculations,
Restrictions for Highly Hazardous Actives,
What’s in ISPE’s Risk-MaPP,
11:30 AM Break
11:40 AM What’s in EMA’s Guidance on Dedicated Facilities,
Impact of Health-based Approaches,
Suggested Approaches for Going Forward,
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: 258

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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

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"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