In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. Attendees will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents and also they will learn how to react to discrepancies found in these records.
Why Should You Attend:
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.
Learning Objectives:
- 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)
Areas Covered in the Webinar:
- 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.
Instructor Profile:
Danielle DeLucy
Owner, ASA Training and Consulting, LLC
Owner, ASA Training and Consulting, LLC
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.