DEC 12

Implementation and Management of GMP Data Integrity


All other Events(no CPF)




  12 Dec 2017 through 12 Dec 2017


  Aurora, Colorado, United States

Website URL:

Sponsoring organization:

  Training Doyens


  Medicine & Health > Pharmaceutical/Medicinal

Event description:

OVERVIEW Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in current Good Manufacturing Practices (CGMP) for US Food and Drug Administration (FDA)-regulated industry. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. The reasoning behind this complex issue is quite simple: if the integrity of laboratory data is compromised, batches of finished goods may not comply with regulatory authorization terms and, consequently, will not be released for sale. WHY SHOULD YOU ATTEND In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, biologics and medical devices. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. Attendees will obtain an understanding of the Regulatory expectations for Data Integrity. The information provided at the webinar will enable the attendees to review practices at their own site and identify gaps in their own practices. AREAS COVERED • Examples of data integrity pitfalls • Part 11 compliance data integrity issues Review of FDA citations related to data integrity WHO WILL BENEFIT Quality Assurance/Quality Control Directors, Managers, and Specialists Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists Engineering/Development Directors, Managers, and Specialists LEARNING OBJECTIVES 1. Understand the current regulatory position on data integrity 2. Discover the criteria for data integrity 3. Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory 4. Learn about approaches to improve data integrity in a laboratory environment 5. Part 11 compliance 6. FDA citations related to data integrity issues For more detail please click on this below link: Email: [email protected] Toll Free: +1-888-300-8494 Tel: +1-720-996-1616 Fax: +1-888-909-1882

Posting date:

15 November 2017
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