Out of Specification Investigations: A New Look at the Topic

Duration: 60 Minutes
Despite the guidance that is in place, many regulatory cite poor out-of-specification (OOS) investigations and these features high up on lists of inspectorate findings. Notably these are renewed calls by agencies for the OOS investigation to be thorough, timely, unbiased, well documented and scientifically sound. Hence key challenges for many companies are with having a clear understanding of regulatory expectations on how to handle OOS investigations. To help, this presentation takes a look at how OOS are conducted and presents different ways through which OOS investigations can be improved.
Out of Specification Investigations
Instructor: Tim Sandle
Product ID: 509083
Objectives of the Presentation
  • Why there is a need for good OOS investigations
  • What OOS investigations cover?
  • How to write a good OOS
  • Detailing what to investigate and how
  • How to carry out root cause analysis
  • How to develop a testing hypothesis
  • How to conclude an OOS effectively
Why Should you Attend
To learn how to run good OOS investigations, to get at the root cause and to prevent issues from reoccurring. The presentation will also outline what regulatory agencies expect from good OOS investigations.

Areas Covered
  • Where did the OOS come from (the legal and GMP basis)
  • Common GMP audit observations about OOS reports
  • How to construct a sampling plan
  • OOS investigations
  • OOS risk assessments
  • Interviewing analysts
  • Setting CAPA
  • Different phases of the investigation
  • Case studies
Who will Benefit
  • Laboratory managers
  • QC staff
  • QA professionals
  • R&D
  • Manufacturing
  • Those working in chemistry, biochemistry, stability, regulatory and microbiology
Topic Background
According to many GMP regulators, based on comments made at conference, the issue of effective OOS investigations continues to be a significant challenge for both many laboratories required to conduct investigations and for inspectors and auditors tasked with reviewing investigations. One frustration is with poor scientific thinking, a hypothesis not being set and without conclusions being backed by sound and suitable data. This webinar attempts to address these concerns.
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  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. 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.
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