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HomeResearch & DevelopmentCleaning Validation – Health Based Limits and Beyond: Answers to Current Industry Gaps

Cleaning Validation – Health Based Limits and Beyond: Answers to Current Industry Gaps

Teachers
Thomas Woody
Category:
On-Demand Courses/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 90 minutes
On-demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

The world of cleaning validation is undergoing a significant transformation related to how product and cleaning agent carryover limits are calculated.  The European Medicines Agency in their 2014, “Guideline on setting health based exposure limits,” is requiring the use of toxicologically derived limits for determining carryover.  Other industry agencies have also described their use in cleaning validation programs including International Society for Pharmaceutical Engineering (ISPE) and Active Pharmaceutical Ingredients Committee (APIC).  But how do companies interpret the regulations and expectations for their cleaning validation programs?  What happens if they do not consider the toxicological limits for their products from regulatory and science based perspectives?  What types of products does it apply to?  What is an ADE and PDE?  How and where does a company start?  Answers to these questions and much more will be discussed in this interactive course.

Another common cleaning validation gap is the need and benefit of a robust cleaning development program.  This discussion will focus on how to perform lab studies to identify critical cleaning parameters, and then how to apply the results to full-scale manufacturing equipment while optimizing the cleaning processes.   A good investment in this area will pay dividends for manufacturing companies for the life of the product.

Additionally, the lack of periodic monitoring of validated cleaning processes in the industry will be discussed.  This gap is significant and leads to regulatory issues and lack of assurance that the cleaning processes are in a state of control.  This course will discuss the two-part strategy using historical data and real-time testing to ensure compliance with the added benefit of determining the next monitoring point based on data.

LEARNING OBJECTIVES

Practical anecdotes and tips will be shared from lessons learned “in the trenches” executing cleaning programs at manufacturing companies.  Cleaning validation can be daunting, but through this course, information will be shared to impart confidence and direction.  You will also receive the following updates:

  1. Impact from the recent EMA Q&A forum on cleaning validation – what you need to know
  2. Global regulatory updates
  3. Enforcement trends

Who Should Attend

WHO SHOULD ATTEND

This course will be beneficial and practical to anyone who is involved in any aspect of cleaning validation from initiating to executing the work. This includes titles ranging from company presidents to cleaning validation engineers. This course will also assist QA personnel who have to review, approve, and ultimately defend the program to regulatory auditors and clients. Pharmaceutical and biopharmaceutical industries will gain the most applicable information from the course.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Thomas Woody
Experience managing and executing all aspects of a cleaning validation program and defending it routinely before regulatory agencies.

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Clear
Duration: 90 minutes
On-demand
Includes handouts

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