Data Integrity Practices for the Laboratory and Beyond

February 08, 2019

CfPA-The Center for Professional Advancement, Online Live
April 22, 2019 at 11:00 a.m.–12:30 p.m. (ET)

Who Should Attend?
This online training is designed for professionals in the Pharmaceutical, Medical Device and other life science industries. It will be especially valuable to the personnel and management, including senior management, in these areas:
  • Quality Control
  • Manufacturing
  • Regulatory Affairs
  • Quality Assurance

Course Description

In this 90-minute accredited training, we will discuss effective batch record review. 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.

Can't Make this LIVE Webinar?
Simply select the On Demand option when registering and we will send you the link to view the recorded version.

On Demand available approximately 3 business days after the live offering.

Organized by:

CfPA-The Center for Professional Advancement

Invited Speakers:

Danielle DeLucy, MS; Owner, ASA Training & Quality Consulting LLC

Danielle DeLucy, MS, is currently the owner of ASA Training & Quality Consulting, LLC, an Independent Consultant Agency to the Biologics and Pharmaceutical Industries specializing in the areas of Quality Assurance and Quality Systems. Prior to this role, Danielle has been in the industry for 18 years serving in numerous Quality Management roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.

Deadline for Abstracts:

n/a

Registration:

Please click here for registration information.

E-mail:

Jmorbit@cfpa.com

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