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. Manufacturing is prone to any kind of errors, deviations, unforeseen events. It is of utmost importance to know what you need to do in case of any unforeseen situations. GDP is part of GMP and if you know it by heart, it prevents a lot of wrongdoings and minimizes the chance of being spotted by the regulatory bodies in their audits.
It enables you to perform faster with much more confidence knowing what you are doing is GMP compliant. Furthermore, having this knowledge enables you to correct the situation even if a deviation happens while still remaining GMP compliant. Finally, you will know what kind of information to include in the most popular records dealt with in the manufacturing environment.
Areas Covered in the Session:
US Pharmacopeia General Chapter <1029>:
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:
Deviations and investigations
Certificate of Analysis (C of A)*
Standard Operating Procedure (SOP)*
Protocols & reports*
Retention of documents
- Anybody who works in a Regulated Environment
- Manufacturing & Production Personnel / Managers
- Research and Development Personnel (R&D) / Managers
- Quality Assurance & Quality Control Personnel / Managers
- Laboratory Personnel / Managers
- Validation Specialists
- Clinical Trial Personnel
- Project Managers
• Anybody who works in a Regulated Environment
• Manufacturing & Production Personnel / Managers
• Research and Development Personnel (R&D) / Managers
• Quality Assurance & Quality Control Personnel / Managers
• Laboratory Personnel / Managers
• Validation Specialists
• Clinical Trial Personnel
• Project Managers