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