Live Webinar

Good Documentation Guideline (Chapter <1029> USP)

insert_invitation Friday, 27th April, 2018
access_time 01:00 PM EDT | 10:00 AM PDT
timelapse 60 mins with 10-15 mins of Q and A

Short Abstract

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 60-min 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

If you are involved in any product manufacturing, knowing GDP regulations is a must for you. It prevents a lot of errors and minimizes the chance of being spotted by the regulatory bodies in their audits.

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.

Learning Highlights:

  • History of the chapter as to how and why it was created
  • Purpose of development of this chapter
  • 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*
  • Training documentation


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