Effective Batch Record Review

Event Information
Product Format
Prerecorded Event
Conference Date
Wed, Mar 15, 2017
60 minutes
Product Description

Understand How to Effectively Review Batch Records and Ensure High Quality Products!

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

The production and manufacture of pharmaceuticals, biologics, medical devices, etc., involve critical processing parameters. In order to properly document these processing parameters, a strong batch record review system is essential.

This webinar with expert speaker Danielle DeLucy, MS, will analyze each of these necessary elements of the batch record review process. Upon completion of this session, you will learn the fundamentals for reviewing batch records in a pharmaceutical environment. You will hear about the proper training that must be demonstrated to be considered a suitable reviewer of these critical documents and you will learn how to react to discrepancies found in these records.

Session Highlights:

  • Recognize regulatory requirements for batch records and batch record review
  • Understand the essential and necessary qualifications and training of batch record reviewers
  • Establish a working relationship between production and quality reviewers
  • What to do when a batch fails to meet specifications (discrepancies and deviations)
  • Parameters of efficient review of batch records – good documentation practices, compliance to essential quality attributes and critical processing parameters
  • Skills and responsibilities of an effective batch record reviewer
  • Tools to achieve an effective batch record review
  • Ensuring Production and Quality reviewers coincide with their reviews
  • Creating an extensive training plan for batch record reviewers and when they can be considered “qualified” to review a record

Who should attend?

  • Quality Assurance batch record reviewers
  • Production personnel and Production Managers who review batch records

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

Order Below or Call 1-866-458-2965 Today

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About Our Speaker

Danielle DeLucy

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems  assistance in order to meet Regulatory compliance. Prior to this role, Danielle 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...   More Info
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