Good Documentation Guideline (Chapter <1029> USP) 2021

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