Product Release 2021 - Batch Record Review and Product Release Training

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.
• Recognize regulatory requirements for batch records and batch record review
• Discover the essentials of batch record reviewer qualifications and training
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
Speaker:
Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems.