The Latest Update on 21 CFR Part 11


ID:          1895
SKU:      EB-0004-RC
Type:     e-Book

In this comprehensive guide (21 CFR Part 11 e-Book), Part 11 is discussed since it remains in effect during FDA reexamination period. Also, we  elaborate on the latest guidance published in Aug 2003.


Authors’ Bio:

Dr. Afsaneh Motamed Khorasani 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.

In March of 1997, FDA issued final 21 CFR Part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.

FDA has spoken about part 11 at many conferences and has issued 6 pieces of draft guidance to help interpret 21 CFR Part 11 in the past. However, concerns have been raised particularly in the areas of its requirements for validation, audit trails, record retention, record copying, and legacy systems.

On February 25, 2003 (68 FR 5645), FDA announced the withdrawal of the 21 CFR Part 11 draft guidance documents on validation, glossary of terms, time stamps, maintenance of electronic records, and CPG 7153.17. In Aug 2003, the last guidance was issued to describe how FDA intended to exercise enforcement discretion with regard to certain part 11 requirements during the re-examination of 21 CFR Part 11.

This e-Book discusses 21 CFR Part 11 since it remains in effect during FDA reexamination period. Also, we will elaborate on the latest guidance published in Aug 2003.

Learning Highlights
By reading / following this 21 CFR Part 11 e-Book, you will be able to:

  • Understand the history / current situation of 21 CFR Part 11
  • Comprehend how 21 CFR Part 11 applies to what you do
  • Become familiar with the aspects of previous FDA guidance documents to address e-records / e-signatures
  • Become familiar with the latest guidance document published by FDA as of Aug 2003 for 21 CFR Part 11
Who Can Benefit From This 21 CFR Part 11 e-Book
  • QA / QC Managers & specialists
  • Chemists / pharmacists
  • Hospital and research technicians / scientists
  • Employers in pharmaceutical & medical device industry
  • Lab managers (pharmaceutical & medical device industry)
  • Company management
  • Auditors
  • ID:                                    1895
  • SKU:                                EB-0004-RC
  • Type:                               e-Book
  • Format:                          Downloadable PDF File (.pdf)
  • Date of Last Update:   Aug 07, 2018
  • Length:                           19 Pages
  • Course Level:                Moderate/Advance
  • Price:                              $100.00
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