COURSE ID 2792

Laboratory Controls: Anticipate the Systems Based FDA Inspection

AVAILABLE On-demand
90 Minutes

On-Demand

Offering Price
$ 295
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Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

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.

This training is one part of the 10-course series required for the GMP Laboratory Control Professional Certification Program. Attend this as a step in the certification process or as a stand-alone course for personal career advancement and training.

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

 

This training is part of of a 10-course series required for the GMP Laboratory Control Professional Certification Program.
Click the image below to learn more about this Certification Program.

course instructor

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

Danielle DeLucy, MS’s Courses
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. Prior to this role, Danielle has been in the industry for 23 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, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.