Overview: The FDA and its European counterpart, EMA, require drug manufacturers 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.
An efficient and effective batch record review process provides pharmaceutical companies with two strategies. First, this effort is key to maintaining control of your firm's manufacturing operations, eliminating any guesswork and aiding in the resolution of atypical occurrences. And, it enables a company’s to maintain and demonstrate a compliant posture, a sure way to avoid any quandary with regulatory agencies. Certain elements, practices and procedures are crucial to such an efficient and effective review process. As well, such logistics can only be put in place through an proactive training regime and review management system. This webinar will analyze each of these necessary elements of the batch record review process.
Why you should attend:
Recognize regulatory (FDA/EU) requirements for batch records and batch record review
Modeling best practices of a technical review of batch records
Discover the essentials of batch record reviewer qualifications and training
Acquire confidence in determining the final decision or recommendations.
Establish a working relationship between production and quality reviewers
What to do when a batch fails to meet specifications (discrepancies)
Areas Covered in the Session:
Regulatory requirements for batch record review
Skills and responsibilities of an effective batch record reviewer
Tools for effective batch record review
Production and Quality reviewers
Training plan for batch record reviewers
Who Will Benefit:
Quality assurance batch record reviewers
Production personnel who are responsible for batch record entries and reviews