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Aging Pharmaceutical Facilities - A Deep Dive into the Risk Factors 

Thursday, 17 October 2019 10:00 AM PDT, 01:00 PM EDT

Training Duration = 60 min                  Sponsored by Online Compliance Panel

Click Here to register $229.00

Click Here to register and receive CD recording $329.00

Many pharmaceutical facilities are aging and undergoing "drift", centered on attempts make good the ageing plant through modifications, repairs and alterations to procedures, as well as responding to more frequent breakdowns and mishaps.

This brings with it contamination control risks, as well as problems of scale. This webinar assesses the primary risks.

Objectives of the Presentation:

  • To understand the contamination risk factors impacting on an ageing facility
  • To review regulatory concerns about ageing facilities e.g. FDA warning letters
  • To identify the risks associated with running an ageing facility
  • To develop a strategy to address the risks
  • Discussing what happens is there is insufficient time or where production is set to increase
  • How technology transfer can be handled in the ageing plant
  • Microbial contamination risks

Why Should You Attend:

To understand the risk factors associated with running an 'older' facility that produces pharmaceuticals or healthcare products, and develop a strategy to correct or control the risks.

Areas Covered:

  • What is an aging facility?
  • What do regulators expect from aging facilities?
  • Risks associated with incremental upgrades
  • Risks linked to equipment obsolescence
  • Risks linked with increased processing
  • Case studies into real-life ageing facilities
  • Microbiological concerns
  • Validation status
  • Quality systems
  • Risk management approaches

Instructor Profile:

Dr. Tim Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy.

Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.


Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle's current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.