Basic Limit Setting for Cleaning Validation Protocols and the Latest Regulatory Expectations

Live, Interactive Training Webinar

Date: Tuesday March 26, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc Biography>>>

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This live and interactive training webinar will focus on the basic issues involved in setting limits for active ingredients in cleaning validation protocols. This is often called the Maximum Allowable Carryover (MAC or MACO) calculation. Setting appropriate acceptance residue limits is a critical elements of an overall cleaning validation program. Limits are established for patient safety and product quality, but may also be set based on production efficiency. Variations on how it is presented or expressed by different companies will be presented. Specific situations in which a safety factor other than 0.001 might be used will be explored. Handling of unique situations like adult/child doses and doses based on body weight (or skin surface area) will be covered. The proper use of “default values” will be explained, as well as alternatives to use for default values. Approaches for highly hazardous actives will be covered. The regulatory basis for these approaches will be discussed.

Learning Benefits:
-Understanding the terminology applied to setting limits for cleaning validation.
-Understanding and applying limits approaches for actives in both drug product and API manufacture.
-Understanding special situations which may require modification of the basic calculations.
-Applying the use of default values.
-Understanding and applying what visually clean means.
-Learn what regulatory documents say about setting limits.

Webinar outline and time breakdown:

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Terminology and Definitions,
Basic Dose-Based Calculations,
ADE “Health-based” Limits,
Variations on How Presented,
Special Situations,
11:30 AM Break
11:40 AM Determining Protocol Compliance,
Dosing Issues,
Use of Default Values,
API Manufacture,
Regulatory Issues,
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: 252

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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