Good Documentation Practices for GMP Operations

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: $295.00
  • Refund Policy

Overview:

Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance.

To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices.

According to the FDA, if it isn't written down, it didn't happen. As well, if it isn’t written down clearly, it didn’t happen either. GMP compliance (21CFR, Part 211) requires the use of good documentation practices. These practices apply to all pharmaceutical manufacturing and support areas. Good Documentation Practices describe the required activities and steps to use when recording data and other handwritten entries. Personnel who work with documentation must be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance. During this 1-hour webinar, we will review the Good Documentation Practices plus demonstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena.

Why you should attend: The Learning Objectives of this presentation include:

  • Discover what the regulations say about documentation practices
  • Learn what your signature and/or initials mean on a document
  • See how to correct errors and omissions in data entry
  • Learn "Do's" and "Don'ts" of documentation practices
  • Learn how to attach raw data to records
  • Review rounding and limit expression determinations

Areas Covered in the Session:

  • 21CFR Part 211 and Eudralex references to documentation
  • Correcting errors and omissions
  • Dates and formats
  • Meanings of initials and signatures
  • Use of "NA"
  • Comments and explanations
  • Handling raw data (charts, strips, printouts)
  • Blanks
  • Entering numerical data

Who Will Benefit:

  • Production personnel (operators, supervisors)
  • Laboratory personnel (chemists, technicians, supervisors)
  • Batch record reviewers
  • QA Auditors of Production and Laboratory Documents
  • Validation, Engineering
  • Maintenance personnel (mechanics, supervisors)
  • Warehousing personnel
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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