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
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
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
