Good Documentation Guideline (Chapter USP)

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*
• Training documentation
• Retention of documents

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