Laboratory Controls: Anticipate the Systems Based FDA Inspection

December 15, 2017

CfPA-The Center for Professional Advancement, Online Live
January 11, 2018 at 11:00 a.m.–12:30 p.m. (ET)

Who Should Attend?
This online training course is intended for professionals in the Pharmaceutical and related life science industries. It will be especially valuable to:

  • Quality Control Personnel & Management
  • Manufacturing Personnel & Management
  • Senior Management
  • Regulatory Affairs Personnel & Management
  • Quality Assurance Personnel & Management

Course Description

In this 90-minute accredited training, we will discuss laboratory controls. It will focus on all of the systems that are in a laboratory that will be audited by an FDA inspector in a typical systems-based inspection. After this webinar, you will fully understand how to prepare your laboratory for FDA. Many QA and QC personnel in the pharmaceutical industry are not familiar with the FDA systems-based inspection model. They are also not aware of the types of 483 observations that many FDA auditors make today. One of the most scrutinized areas during these inspections is the laboratory. Because of this, it is important for lab personnel to know the techniques used the FDA inspections during these types if audits. Knowing the systems, the FDA will look at is also key so that the lab can be properly prepared for the audit.

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.

This course will be available On Demand: January 12, 2018

Organized by:

CfPA-The Center for Professional Advancement

Invited Speakers:

Danielle DeLucy, MS; Independent Consultant to the Biologics and Pharmaceutical Industries

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 15 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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