RAPS - This course has been pre-approved by RAPS as eligible for up to 4 credits towards a participant's RAC recertification upon full completion.
Training 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
Module 1 Regulatory Requirements for GMP Documents - Batch Records and Beyond
- Review Good documentation requirements for batch records
- Types of Regulated documents and relative importance
- Master Batch Record Templates - Control and Issuance
- Manufacturing Records - In process and final product
- Specifications - Quality Review
- Investigations - Deviation and Out of Specifications
- Change Control Process
Module 2 Methods for Batch Record Review
- Defining the Review process
- Batch Record SOP development
- Roles and responsibilities of reviewers both Quality and Operations
- Effective review practices and tools to identify discrepancies
Module 3 Methods for Data Review and Actions taken for Deviations
- Review of Analytical Data
- Out-of Specification test results and deviations
- Case Study - Review of a Mock Batch Production Record
Who will Benefit?
- Quality Assurance batch record reviewers
- Production personnel
- Production Managers who review batch records.
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.
4.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 4 credits towards a participant's RAC recertification upon full completion.
World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria
