6 Hour Virtual Seminar on Batch Record Review and Product Release

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.

Course Objectives:

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

Why Should You 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)

Course Outline:

•  Review Good documentation requirements for batch records
•  Types of Regulated documents and relative importance
          o Master Batch Record Templates - Control and Issuance
          o Manufacturing Records - In process and final product
          o Specifications - Quality Review
          o Investigations - Deviation and Out of Specifications
          o Change Control Process

Methods for Batch Record Review

          o Defining the Review process
          o Batch Record SOP development
          o Roles and responsibilities of reviewers both Quality and Operations
          o Effective review practices and tools to identify discrepancies

Methods for Data Review and Actions taken for Deviations

          o Review of Analytical Data
          o Out-of Specification test results and deviations

Case Study - Review of a Mock Batch Production Record

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Quality Assurance batch record reviewers
• Production personnel and Production Managers who review batch records
• Compliance Auditors
• Manufacturing Management & Scientist
• Other professionals who review batch records

Contact Us

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 filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.

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