Reducing Drug and Device Batch Release Times: Expert Reveals Secrets to Improved BPR/DHR Review and Assessment Webinar, April 30, 2015

Share Article

In this webinar, 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 attendees 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.

Reducing Drug and Device Batch Release Times:
Expert Reveals Secrets to Improved BPR/DHR Review and Assessment
**FDAnews Webinar**
April 30, 2015 — 11:00 a.m. – 12:30 p.m. EDT
http://www.fdanews.com/batchreleasetimes

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.

In this webinar, 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 attendees 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.

Attendees 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

Meet the Presenter:
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.

Who Will 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

Conference Details:
Reducing Drug and Device Batch Release Times:
Expert Reveals Secrets to Improved BPR/DHR Review and Assessment
**FDAnews Webinar**
April 30, 2015 — 11:00 a.m. – 12:30 p.m. EDT
http://www.fdanews.com/batchreleasetimes
Tuition: $287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/batchreleasetimes
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Michelle Butler
FDANEWS
+1 (703) 538-7665
Email >
FDAnews
Like >
Visit website