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Good Documentation Guideline (Chapter <1029> USP)

4151
Duration : 60 Minutes

Dr. Afsaneh Motamed Khorasani,

Dr. Afsaneh Motamed Khorasani, PhD, is a Medical and scientific Affairs expert and a Senior Scientist with a strong background in biomedical science and clinical trial/research. She has a tenured and diverse range of experience in medical affairs, basic and industrial clinical research and develop Read more


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.

Course Objective:

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.

Course Outline:

• History of the chapter as to how and why it was created
• Purpose of development of this chapter
• Chapter outline:

o Principles of Good Documentation
o Data collection & recording
o Different types of GMP Documents:
o Laboratory records
o Equipment-related documentation
o Deviations and investigations
o Batch records
o Certificate of Analysis (C of A)*
o Standard Operating Procedure (SOP)*
o Protocols & reports*
o Analytical procedures*
o Training documentation

• Retention of documents

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

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
• Lab Managers
• Engineering and Manufacturing

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

100% MONEY BACK GUARANTEED

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Subject : Good Documentation Guideline (Chapter <1029> USP)


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