Good Documentation Guideline (Chapter <1029> USP)

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:

1. Should we handle electronic documents differently than paper documents?
2. What is the advantage of adding metadata (filling out the "properties") of a file?
3. Why not just use Google Drive as a document management system?
4. What is the importance of Signature Log or Signature Logbook for performing or supervising any specific GMP activity?
5. How does a Good Documentation helps comply with 21 CFR part 11 and FDA Regulations?

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

Dr. Afsaneh Motamed Khorasani
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. Before joining this company, Dr. Motamed Khorasani has served as an independent consultant, director of medical affairs, senior medical sciences liaison, senior scientist and senior medical analyst at Merck (MDS), Johnson & Johnson, United States Pharmacopeia Convention (USP), Amgen, Baxter International, Covidien (eV3), Radient Pharmaceuticals, AMDL Diagnostics, Microbix Biosystems, Neometrix Consulting, Mount Sinai Hospital, Princess Margaret Hospital, and Vancouver General Hospital.

She has more than 20 years of experience and many National and international certificates in GLP, GMP, ICH-GCP and global regulatory compliance for clinical trials and is a member in a number of professional associations, including: American Association of Cancer Research (AACR), American Medical Writers Association (AMWA), Regulatory Affairs Professional Society (RAPS), American Society of Quality (ASQ), Project Management Institute (PMI), and Intellectual Property Institute of Canada (IPIC). Dr. Motamed Khorasani's research has focused on high throughput approaches in the context of cancer informatics with a particular interest in the use of comparative analysis for the mining of integrated oncology datasets that include protein-protein interaction and gene expression profiling. She has published and presented more than 50 papers, abstracts and articles in highly regarded scientific journals and high profile conferences and scientific meetings.

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