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
Frequently Asked Questions:
- Should we handle electronic documents differently than paper documents?
- What is the advantage of adding metadata (filling out the "properties") of a file?
- Why not just use Google Drive as a document management system?
- What is the importance of Signature Log or Signature Logbook for performing or supervising any specific GMP activity?
- How does a Good Documentation helps comply with 21 CFR part 11 and FDA Regulations?
Instructor Profile:
Dr. Afsaneh Motamed Khorasani
Vice President of Medical Affairs, Easy Global Training
Vice President of Medical Affairs, Easy Global Training
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 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.