Good Documentation Guideline (Chapter 1029 USP)
This 60-min webinar will familiarize participants with USP Chapter 1029 on good documentation guidelines, And This session will wrap up the general concept and will provide information as to what needs to be documented in certain records, Finally, you will know what kind of information to include in the most popular records dealt with in the manufacturing environment.
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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:
Who Will Benefit:
- 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
- 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
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