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

Date: April 26, 2017
Duration: 90-Minutes
Price: $299 - Includes Bonus Handouts!

Course Description:

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.

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:

  • Impact from the recent EMA Q&A forum on cleaning validation - what you need to know
  • Global regulatory updates
  • Enforcement trends

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.

TJ Woody fda Cleaning and Process Validation instructor

Thomas “TJ” Woody heads the Cleaning and Process Validation group at Integrated Project Services (IPS).  TJ has over 27 years in the biopharmaceutical and pharmaceutical industries.  His unique perspective is driven from his varied experience working for large and small companies in validation and operations.  This experience includes managing and executing all aspects of a cleaning validation program and defending it routinely before regulatory agencies.

At IPS, his passion is assisting clients in identifying gaps and working together with them to develop workable compliant solutions.  He is not a consultant that lectures as a living, but one that has battle-scars from real life experiences executing cleaning validation.

TJ holds a bachelor’s degree in chemistry from Millersville University and is a Certified Quality Auditor through the American Society for Quality (ASQ).