Overview

These module will provide insight into what the FDA is looking for during an audit and provide participants with tools and case studies for each of the topics.

Why Should You Attend

The FDA is a regulatory body that can shut down a manufacturing facility then the company loses time and money due to the closure. For this webinar series, we are providing the most common observations given by the FDA and provide ways to prevent these most common observations.

Webinar Takeaway

  • Why do we test prior to release?
  • Why do we test materials coming in?
  • Safety, Quality, Identity, Potency, Strength
  • USP/EP
  • Method Validation
  • Setting specifications
  • Appropriate (Make sense?)
  • What should have a specification?
  • Based on Data
  • Get input from all Departments

Who will Benefit

  • Manufacturing Personnel (Associates and Supervisors) and Managers.
  • Quality Control Personnel (Associates and Supervisors)
  • Quality Assurance Personnel (Associates and Supervisors)
  • New Graduates just entering into the Pharmaceutical Manufacturing Industry. 

Industries who can attend

This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Faculty Carl Patterson


Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance Professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However, his avid interest in all things biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse. Furthermore, Carl holds various degrees and certifications, including an M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.

Faculty Carl Patterson

Choose a Purchase Options

$289

Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 60-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$399

MP3 Download (DVD)

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.