Laboratory Controls: Anticipate the Systems Based FDA Inspection

Danielle DeLucy, M.S.

Course description

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 of audits. Knowing the systems, the FDA will look at is also key so that the lab can be properly prepared for the audit.

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 the FDA. 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.

Upon completion of this course, you will be able to:

• List what makes up a Laboratory Control System
• Discuss the responsibilities of the QC and QA personnel before and during the audit
• Review the known high‐risk areas to assess the level of compliance in your own laboratories
• Improve and develop systems and procedures that will sustain a compliant laboratory operation

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