Overview

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.

This webinar will analyze each of these necessary elements of the batch record review process.

Why you should attend

•   Recognize regulatory requirements for batch records and batch record review

•   Discover the essentials of batch record reviewer qualifications and training

•   Establish a working relationship between production and quality reviewers

•   What to do when a batch fails to meet specifications (discrepancies and deviations)

Webinar Takeaway

  • Regulatory requirements for batch record review
  • What to look for while reviewing batch records, i.e., good documentation practices, compliance to critical quality    attributes and critical processing parameters
  • Skills and responsibilities of an effective batch record reviewer
  • Tools for effective batch record review
  • Ensuring Production and Quality reviewers coincide with their reviews
  • Extensive Training plan for batch record reviewers and when they can be considered “qualified” to review a record

Who will Benefit

•   Quality Assurance batch record reviewers

•   Production personnel and Production Managers who review batch records

Industries who can attend

This 240-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Faculty Danielle DeLucy


Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy has been in the industry for 15 years serving in numerous quality management roles, such as the director of product quality, the oversight of sterility assurance practices and provided QA oversight of numerous filling and packaging operations.

Faculty  Danielle DeLucy

Choose a Purchase Options

$495

Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 240-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$596

MP3 Download (DVD)

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.