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 seminar will analyze each of these necessary elements of the batch record review process.
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 seminar 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)
Areas Covered in the Session
- 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
Agenda
I. 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
II. 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
III. Methods for Data Review and Actions taken for Deviations
- Review of Analytical Data
- Out-of Specification test results and deviations
IV. Case Study - Review of a Mock Batch Production Record
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 17 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.Who Should Attend
- Quality Assurance batch record reviewers
- Production personnel and Production Managers who review batch record
