Reducing Drug and Device Batch Release Times - Webinar CD/Transcript

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Reducing Drug and Device Batch Release Times: Expert Reveals Secrets to Improved BPR/DHR Review and Assessment

Error-filled or confusing batch production records (BPRs) and device history records (DHRs) can make or break the efficient release of a product.  Delayed release times are one of industry’s top challenges.

Plus, batch records are magnets for FDA investigator’s observations.  A vast majority of BPR – and - DHR related 483 and warning letter observations are the result of obvious deficiencies in the documentation.

Noted process expert, Jerry Dalfors of JD Technologies — who has trained many FDA field investigators, written and supported FDA’s work on the Process Validation guidance documents and whose work has never received a 483 — will lead you through the intricacies of developing and improving BPRs and DHRs.  These best practices will speed batch release times, reduce errors and provide attendees greater confidence when dealing with investigators.

Using sample batch records during the presentation, Jerry will reveal the secrets to aligning attendees’ processes with their documentation and assuring they teach operators in the proper use of the documents.

You will learn:

  • Proven strategies for how to engineer out the opportunity for employee errors
  • Tips for improving the review process so there are no corrections that need to be made during final review
  • How to assure intermediates within a final lot have a separate BPR or DHR (an often overlooked FDA requirement)
  • Best practices for writing BPRs/DHRs to assure they generate objective evidence — thus speeding up review and release times
  • How to create Developing Incident Tracking Systems that assure all incidents are recorded as they occur and noted properly within the lot packet
  • The nine instructions given to FDA investigations regarding review of batch records
  • How to educate employees on the importance of BPRs/DHRs; they are treated as legal documents and need to stand up in court if necessary
  • How to build a statistical review process that meets FDA’s expectations — if you don’t have a qualified statistician reviewing your data, you’re in trouble

This course will be of benefit:

  • QA/QC personnel
  • Compliance personnel
  • Manufacturing and operations executives
  • Process validation and Lean Six Sigma experts
  • Regulatory affairs professionals
  • SOP development and training executives

From the following companies:

  • Pharmaceutical companies
  • Biologics companies
  • Device companies
  • Diagnostic companies
  • Combination product manufacturers
  • OTC manufacturers
  • Contract manufacturing organizations

Jerry Dalfors, Principal, JD Technologies — Mr. Jerry Dalfors has extensive (40+ years) of consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held management positions with a multitude of major pharmaceutical and biotechnology companies.

He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems and FDA briefing and submittal documents.  In addition, he has lead project management of several multimillion dollar projects; including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation. Plus, he has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems that include:  customer complaint management, deviation management, CAPA and associated site-wide employee training.

Each of his projects has been received and accepted by the FDA and other regulatory agencies. Jerry is considered an expert in most aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics.  None of his work has ever received a 483, but he has corrected and prevented many as well as leading warning remdiation.