Date: 8th - 22nd September, 2008

Location: web seminar, USA

Summary:
Clinical, Cosmetic, Pharmaceutical, Water - Training

The FDA, as well as its European counterparts, requires drug manufacturers to have written procedures in place to document production and process control, better known as batch records. Additionally, written procedures for the batch record review process must be in place to determine compliance with these procedures, as well as identify any discrepancies or failures. The cause of any apparent failure, discrepancy or out-of-specification result must be investigated and reported.

Thorough batch record reviews and investigations provide pharmaceutical companies with two strategies. First, this effort is integral in maintaining control of your firm's operations, eliminating any guesswork and aiding in the resolution of atypical occurrences. Secondly, it enables your company to maintain and demonstrate a compliant posture, thus avoiding any quandaries with the FDA or other regulatory agencies.

Certain elements and procedures are crucial to an efficient review process and orderly investigations. As well, such logistics can only be put in place through an effective training regime and review management system.

This live and comprehensive 3-part series will analyze the necessary elements of the batch record review process, as well as examine the action plan for investigations and explore the training and management of the entire system.

Learning Benefits:

• Recognize the batch record review expectations of the FDA
  
• How to prepare for a technical review of batch records
  
• Discover the essentials of batch record reviewer training
  
• Acquire confidence in determining the final decision and/or recommendations
  
• What to do when a batch fails to meet specifications (discrepancies)
  
• Identify the basics of an appropriate investigation
  
• Moving from root cause to corrective and preventive action(s)
  
• Establish a working relationship between production and quality reviewers
  
• How to measure the effectiveness of the review process
  

Part 1 (September 8, 2008) Discussion Points:

• Regulatory requirements for batch record reviews
  
• Tools for effective batch record review communication
  
• The electronic batch record system
  
• Regulatory requirements for documentation
  

Part 2 (September 15, 2008) Discussion Points:

• Written procedures for the review and approval process
  
• Defining discrepancies and CAPA [corrective and preventive action(s)
  
• Basics of an investigation and the investigation report
  
• Delineation between Production and Quality reviewers
  

Part 3 (September 22, 2008) Discussion Points:

• Skills and responsibilities of an effective reviewer
  
• Training of batch record reviewers
  
• Record-keeping and metrics
  
• Tying it all together