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Good Documentation Guideline (Chapter <1029> USP) 2021

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

Why Should You Attend:

Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.

This training session will cover the US Pharmacopeia General Chapter <1029> and all aspects of GDP including practices for writing and correcting documentation.

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

Areas Covered in the Webinar:

US Pharmacopeia General Chapter <1029>:

  • History of the chapter as to how and why it was created
  • Purpose of development of this chapter
  • Chapter outline:
    • Principles of Good Documentation
    • Data collection & recording
    • Different types of GMP Documents:
    • Laboratory records
    • Equipment-related documentation
    • Deviations and investigations
    • Batch records
    • Certificate of Analysis (C of A)*
    • Standard Operating Procedure (SOP)*
    • Protocols & reports*
    • Analytical procedures*

Frequently Asked Questions:

  1. Should we handle electronic documents differently than paper documents?
  2. What is the advantage of adding metadata (filling out the "properties") of a file?
  3. Why not just use Google Drive as a document management system?
  4. What is the importance of Signature Log or Signature Logbook for performing or supervising any specific GMP activity?
  5. How does a Good Documentation helps comply with 21 CFR part 11 and FDA Regulations?

Who Will Benefit:

GDP's are meant for use in the production and control of Active pharmaceutical ingredients (APIs), Medical devices, Excipients, Pharmaceutical products, Labs, Dietary supplements and Food ingredients. The following titles will benefit:

  • Regulatory
  • Compliance
  • Audit
  • Quality
  • R&D
  • Scientists
  • Documentation and Validation
  • Clinical Research

Contact Organizer

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(1+) 206-575-7771
World Medical Events Company
12922 SE 299th Street, Auburn WA 98092 USA