Good Documentation Guideline (Chapter <1029> USP)
Dr. Motamed Khorasani is keynote speaker at ComplianceKey and She is a Medical Affairs expert and a Senior Scientist with a strong background in biomedical science and clinical trials. She has a tenured and diverse range of experience in medical affairs, basic and industrial clinical research and development, clinical trials, Medical and regulatory writing and intellectual property. She is currently the Vice President of Medical Affairs at Easy Global Training, which is a US-based firm providing global regulatory, quality and medical affairs training backed by consulting. Before joining this c........
Overview
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 this webinar?
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.
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
- 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 can Benefit:
- 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
Presenter: Craig M Taggart
When: 09/03/2019 | 10:00 AM PT |01:00 PM ET
Price: $189
