Pharmaceutical Manufacturing Batch Record Review

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $275.00
  • Refund Policy

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: The Learning Objectives of this presentation include:
  • 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
Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included quality management of laboratory assessment, site GMP lead auditor, FDA QSIT/Quality Management System manager, 5S coordinator, GMP trainer (annual, ongoing, new hire), OSHA regulations and Process Safety Management training, as well as internal and external public relations.

Kerry is a graduate of James Madison University in Harrisonburg, VA (B.S. in Chemistry) and is an advanced Toastmaster. He has received qualifications and certifications in the areas of facilitation and training, including competency-based curricula. His past affiliations have included ASQ, ASTD, PDA, GMP-TEA, ASPI, and AQP. Kerry is the founder of Summit Consulting, Inc. and has been assisting firms in the areas of remediation and project management within the manufacturing and the laboratory functions for the past two years.


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