Cleaning Validation; Dealing with “Indirect Product Contact Surfaces” and “Non-Product Contact Surfaces” & Regulatory Recommendations

Live, Interactive Training Webinar

Date: Tuesday October 22, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Destin LeBlanc Biography>>>

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Cleaning Validation has traditionally focused on the direct product surfaces of manufacturing equipment. Setting limits and dealing with these surfaces in cleaning validation is relatively straightforward. However, there have been increasing regulatory and industry concerns about indirect product contact surfaces (defined as a non-product contact surface that is in close proximity to open product where there is a reasonable probability of transfer of residues from that surface to the product). A newer concern, particularly for highly hazardous products, is related to residues on non-product contact surfaces.

This live training webinar will focus on these two situations, exploring risks and dealing with these surfaces from a cleaning validation perspective.

Learning Benefits:
-Understand the differences among different types of surfaces.
-Explore how residues might transfer from these surfaces to manufactured product.
-Learn options for setting limits in each case.
-Learn data collection to support risk assessments.
-Explore differing ways to address highly hazardous and non-highly hazardous actives.
-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 of surface types,
Concerns, possible studies and validation issues for indirect product contact surfaces,
11:30 AM Break
11:40 AM Concerns, possible studies and validation issues for non-product contact surfaces,
What regulatory documents say,
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: 260

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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