In the realm of pharmaceuticals, biologics, and medical devices, Regulatory Agencies mandate the presence of meticulously crafted written procedures, known as batch records, to document production and process controls. These critical records stand as a testament to compliance, providing a comprehensive account of all essential processing parameters tied to the manufacturing process.
In this seminar, you will discover how the Batch Record process is vital in properly documenting and validating the entire production and manufacturing journey, guaranteeing adherence to strict regulatory standards. Through in-depth analysis, we'll explore each indispensable element of the batch record review process, empowering you to excel in regulatory compliance and elevate your industry prowess.
In this seminar, you will discover how the Batch Record process is vital in properly documenting and validating the entire production and manufacturing journey, guaranteeing adherence to strict regulatory standards. Through in-depth analysis, we'll explore each indispensable element of the batch record review process, empowering you to excel in regulatory compliance and elevate your industry prowess.
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)
Agenda
Lecture 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
- 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
- Review of Analytical Data
- Out-of Specification test results and deviations
Speaker
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.
