Data Integrity for the Laboratory and Beyond - Careful Considerations for Your Next Audit

Posted By : User Ref No: WURUR52392 0
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  • TypeWebinar
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  • Location Aurora, Colorado, United States
  • Price
  • Date 25-02-2020
Data Integrity for the Laboratory and Beyond - Careful Considerations for Your Next Audit, Aurora, Colorado, United States
Webinar Title
Data Integrity for the Laboratory and Beyond - Careful Considerations for Your Next Audit
Event Type
Webinar
Webinar Date
25-02-2020
Last Date for Applying
25-02-2020
Location
Aurora, Colorado, United States
Organization Name / Organize By
Training Doyens
Organizing/Related Departments
Life Science
Organization Type
Organization/Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Information Technology

Biotechnology

Manufacturing

Medical/Healthcare/Hospital

Location
Aurora, Colorado, United States

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 compliance.

AREAS COVERED

  • Understand the current regulatory position on data integrity
  • Discover the criteria for data integrity
  • Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory
  • Learn about approaches to data integrity risk assessment
  • Learn about approaches to improve data integrity in a laboratory environment

LEARNING OBJECTIVES

The information provided at the webinar will enable the attendees to review practices at their own site and identify gaps in their own practices for maintaining data integrity compliance.

WHO WILL BENEFIT

  • Site Quality Operations Managers
  • Quality Assurance personnel
  • Plant Managers and Supervisors
  • Manufacturing Superintendents and Managers
  • Regulatory Affairs Managers

SPEAKER

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet regulatory compliance.

To Register (or) for more details please click on this below link:

http://bit.ly/30ZhEt3

Email: [email protected]

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

Others Details

Learn the significance of data integrity compliance and how to review your practices and identify gaps in them. The webinar discusses the regulatory expectations in detail to help you optimize your procedures.

Registration Fees
Available
Registration Fees Details
Live Session for one participant $199 Corporate Live Session Group – Max 10 Participants from one location. $549 Recorded Session Get unlimited access to the link for six months $219 Training DVD or USB Flash Drive MP3 files, PDF presentation and reference manual will be delivered on a CD $399 Super Combo Offer 1 Live and Recorded webinar $329 Super Combo Offer 2 Live and Training CD $499
Registration Ways
Email
Phone
Website
Other
Address/Venue
  Training Doyens 26468 E Walker Dr, Aurora, Colorado 80016  Pin/Zip Code : 80016-6104
Landmark
Colorado
Official Email ID
Contact
Training Doyens

26468 E Walker Dr, Aurora, Colorado 80016-6104

[email protected]

   Fax No: 80016
Training Doyens