Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Join us for a webinar on December 01 for a discussion of the webinar

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.

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.

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

Webinar Takeaway

  • Who should be conducting an investigation?
  • When is an investigation necessary?
  • What constitutes an investigation?
  • What is a root cause?
  • What tools can be used to determine the root cause?
  • What if a root cause could not be determined?
  • Corrective Actions/Preventative Actions
  • Case Studies of Investigations and Actions

Case Study 1

Case Study 2

Case Study 3

Faculty John E Lincoln

Faculty John E Lincoln


John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS / CGMP audits and problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

Choose a Purchase Options

$199

Live Webinar - Single Participant 60-mins

You get one log-in for the live 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email


$499

Group Up to 5 Participants ( MP3 Download Free )

You get 5 log-in for the live 60-minute webinar for all the participant, presentation materials , MP3 Download and the opportunity to ask questions by phone and email

$299

Recorded Access Corporate Group

You'll have access to group log-in for an archived recording of the entire 60-minute webinar, including the Q&A period, for 1 location. 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

$389

MP3 Download - Training DVD

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

$289

Live + Recorded Access - Single Participant

You get one log-in for the live & recorded 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email