Change Management System

This webinar will describe how FDA expects firms to establish change management, the sources of change management, the outcomes from change management, and timely outcomes. We will cover some suggestions and Do's and Dont's.

Courtland Imel
Instructor:
Courtland Imel
Date:
Tuesday, April 7, 2020
Time:
10:00 AM PST | 01:00 PM EST
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 502883

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
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Overview:

The presentation will focus on FDA responses to failures in Change Management. The presentation shall describe how FDA expects firms to establish change management, the sources of change management, the outcomes from change management, and timely outcomes. We will cover some suggestions and Do's and Dont's.

Why you should Attend: Why attend? One of the largest areas for FDA review is Change Control Management, as it incorporates Document Control, Validation, Manufacturing, Quality Control, R&D and other groups within an organization.

Many smaller firms struggle with proper documentation to ensure change control management. Larger firms use electronic systems, but again to fail to complete documentation in a timely manner and also review related documentation.

Areas Covered in the Session:

  • Change Control requirements and sources
  • FDA comments on the failure to use proper change management
  • How to set up your Change Management Systems

Who Will Benefit:
  • Quality
  • Manufacturing
  • Regulatory Affairs
  • QA/QC/RA
  • R&D Supply Chain
  • Purchasing


Speaker Profile
Courtland Imel is CEO of Ceutical Laboratories. Courtland has provided training to FDA, Health Canada, and state regulatory authorities. Courtland has spoken at AFDO, AFDOSS, MCAFDO, ASQ, SCC, and Bio. Courtland has 35 years of experience in the industry. Courtland is an SME for several organizations and law firms. Courtland worked for M&M Mars, Allergan, ILEX Oncology, Aronex Pharmaceuticals, Mills Biopharmaceuticals, International Isotopes, Avail Medical Products, Carrington Laboratories, and Ceutical Laboratories, Inc. Courtland has assisted in the submissions of 510Ks, PMAs, IND’s, NDAs, ANDAs, IDEs, and more.

Ceutical Labs provides many services including product development, formulation development, analytical testing (chemistry, microbiology, and physical), regulatory submissions, electronic submissions, consulting, training, quality systems, and more.


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