April 2012

Batch Record Review and Investigation

Date:   4/2/2012 to 4/4/2012
Time:   8:30am to 4:30pm Mon/Tues
8:30am - 12:30pm Wed
Instructor:   John Y. Lee
Location:   Planet Hollywood Resort & Casino, Las Vegas, NV

Course Description

This course concentrates on the practical applications of GMPs and FDA compliance requirements, from the batch record review process to final batch disposition. It begins with practical instructions and techniques for conducting a technical batch record review and identifying batch related discrepancies. The course then shifts to the follow-up investigation of common discrepancies noted from batch production and testing, the decision making process for the final disposition of the batch (i.e., release, reject or rework).

The course lecture provides the attendees with technical knowledge and understanding of the compliance requirements, and "how-to" instructions for batch record review and follow-up investigations. This is achieved by focusing on the interpretation of the GMPs and FDA requirements, using FDA references, industry practices, FDA-483 citations and "real-life"; experiences. The knowledge acquired from the lecture is, then, applied to class workshops to enhance the practical skills for conducting batch record reviews, identifying significant discrepancies, conducting the necessary follow-up investigations, and making the appropriate decision for batch disposition.

All topics and workshops in this course include examples for sterile and non-sterile products.

Course Outline

DAY 1 (8:30am to 4:30pm)

  • GMP Requirements for Batch Records
  • Recommendations for Reviewing Batch Records
  • Training Batch Record Reviewers
  • Technical Review of Analytical Data
  • Variance/Deviation Systems
  • Class Exercise: Deviation and Classification
  • Compliance Requirements for Follow-up Investigations
  • Evaluation of Investigation Findings
  • Review Examples of Investigations
    • Laboratory out-of-specification test results
    • Dissolution test failure

DAY 2 (8:30am to 4:30pm)

  • Review Examples of Investigations (continued)
    • Sterility test failure
    • Labeling and product reconciliation discrepancies
  • Compliance Issues for Product Reprocessing/Rework
  • Case Workshop: Batch Record Review
    • Recognition of batch record discrepancies and GMP compliance deficiencies
    • Identifying the potential causes for the follow-up investigation

DAY 3 (8:30am to 12:30pm)

  • Preparing the Investigation Report
  • Class Workshop: Conducting an Investigation
    • Investigating LAL failure in water-for-injection systems
    • Investigating content uniformity failure

Learning Objectives

This course will teach the attendees how to perform a technical review of batch records to detect hidden compliance and quality problems. They will also acquire the skills to conduct the appropriate follow-up investigation and make the final decision or recommendations.

Who Should Attend?

This course is intended for production, quality assurance and compliance personnel who are responsible for batch record entries and reviews, and compliance investigations. This course is suitable for both entry-level batch record reviewers and compliance personnel as well as advanced-level personnel, including supervisors and managers.

Fees
Seminar Fee Discounted Fee*
Batch Record Review and Investigations $2,500.00 $2,350.00
*Discounted Fee applies if you are attending more than one event during the same week, or if you have multiple attendees from the same company location registering at the same time.
Cancellation Policy
  • All cancellations must be received in writing.
  • Cancellations received after March 9, 2012 and up to March 30, 2012 are subject to a $300 service fee.
  • No refunds or credits are issued for cancellations after March 30, 2012, for failure to cancel, or"no shows."
  • Substitutions will be accepted until March 30, 2012.

If for any reason, PharmaNet® decides to cancel these seminars, we are not responsible for covering airfare, hotel or other costs incurred by the registrants.

PharmaNet® reserves the right to modify topics or substitute speakers without notice.