Webinar Information


Change Management System


Change Management System, Fremont, California, United States
Webinar Title
Change Management System
Event Type
Webinar
Webinar Date
07-04-2020
Last Date for Applying
06-04-2020
Location
Fremont, California, United States

Publish / Maintain / Marketing / Hosted By
Organization Name / Organize By
Compliance4all
Organizing/Related Departments
Online Training
Organization Type
Organization/Company
Webinar Category
Both (Technical & Non Technical)
Webinar Level
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Engineering

Administration/Management

Manufacturing

Medical/Healthcare/Hospital

Location
Fremont, California, United States

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.

Event link:

https://www.compliance4all.com/webinar/-502883LIVE?channel=eventsget_2020_SEO

Contact Info

Netzealous LLC, DBA -Compliance4all

Email: [email protected]

Phone: +1-800-447-9407

Website: https://www.compliance4all.com/

 

Others Details

Contact Info Netzealous LLC, DBA -Compliance4all Email: [email protected] Phone: +1-800-447-9407 Website: https://www.compliance4all.com/

Registration Fees
Available
Registration Fees Details
$150
Registration Ways
Website
Address/Venue
Online  Pin/Zip Code : 94539
Landmark
CA
Official Email ID
Contact
Netzealous LLC,DBA -Compliance4all

39658 Mission Boulevard, Fremont, CA 94539, USA.

[email protected]

   8004479407    Fax No: 94539