Webinars

SQA periodically organizes webinars for its members on a variety of regulatory quality assurance topics. Webinars often are free for SQA members. Occasionally, a webinar is offered for both members and non-members.

Thursday, 18 January 2018, 11:00AM-12:00PM EST

How to Survive a Regulatory Mock Inspection: A Case Study in What Not to Do

Presented by:Penelope Przekop

Description: According to data from the Office of Scientific Investigations (OSI, CDER), FDA conducted close to 8000 inspections in total and inspected almost 4000 clinical investigators between FY 2005 and 2014. In the same period, a total of 515 inspections were performed at sponsors, sponsor-investigators and Contract Research Organizations (CROs).

Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness.  In 2016, an FDA mock inspection of a large pharmaceutical company was conducted resulting in a mock FDA 483 that included three key observations.  The mock inspection resulted in numerous lessons learned by the Sponsor and also the Mock Inspectors that can benefit the industry as a whole. 

The webinar will provide lessons learned from this case study as well as other recent mock inspections conducted by industry consultant, Penelope Przekop. 

Register

RQAP Re-registration units: 0.25 GCP or GLP

 

To Present an SQA Webinar

SQA Committees, Specialty Sections, Regional Chapters and members ONLY:
To request to present a topic in a webinar, please complete a Webinar Request Form. (You will be asked to sign in.)
 

Webinar Library

SQA has developed a library of past webinars for which we had authorization to record the presentation or share slides.

SQA members may "purchase" access to webinar recordings and PDF slides for $0.00. Non-members may purchase access for a small fee. In either case, the purchasing process adds the webinar to your "My SQA Online Education button" on your My SQA page. (You must log in to access this page.)

Webinar descriptions and links for purchasing are in the webinar library:

Webinar Library

You may also go directly to the SQA Store to purchase access.