Establishing a Compliant and Effective Change Control Program

Duration: 90 Minutes
flat 40% off on this webinar use promo code
This Change Control training course will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough Change Control program; as well as, discuss the elements regarding successful management an effective Change Control system.
Effective Change Control Program
Instructor: Kelly Thomas
Product ID: 503167
Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, their product or a quality system. Given the fact that changes are inevitable, it is essential that companies have a compliant and effective change control program to ensure that no unnecessary or cGMP non-compliant changes occur.

Objectives of the Presentation
At the completion of this course, attendees will be able to:
  • Interpret the requirements of the FDA, EU and ICH guidelines regarding compliant Change Control records
  • Understand all the required components of a thorough Change Control record
  • Understand all the elements of effective Change Control management:
    • How to develop a cross-functional team to ensure proper evaluation, approval and implementation of proposed changes
    • Ensure changes do not negatively impact the business or established marketing authorization
    • How to incorporate a Quality risk based approach to evaluating proposed changes
    • Ensure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality Metrics
    • Understand what steps should be taken post implementation to confirm the objectives were achieved
Why Should you Attend
After the completion of this course, the participants will have the knowledge, understanding and tools to develop, implement and manage a highly effective and GMP compliant Change Control Program.

Areas Covered
Regulatory Guidance Review
  • FDA (CFR)
  • EU (EurdraLex)
  • ICH Q10
Review all Elements of a Change Control Record
  • Discuss the importance of utilizing Subject Matter Experts from multiple functional areas to ensure proper evaluation, approval and implementation of proposed changes
  • Ensure changes do not negatively impact the business or established marketing authorization
  • How to incorporate a Quality risk based approach to evaluating proposed changes
  • Ensure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality Metrics
  • Understand what steps should be taken post implementation to confirm the objectives were achieved
How to Present Quality Metrics to Manage Timely Closure of Change Control records
  • Discuss appropriate metrics for change control programs
  • Discuss Key Performance Indicators for change control programs
  • Review a Quality Dashboard example to show how to display metrics / trends
Who will Benefit
Operations employees that participate in Manufacturing, Engineering, Validation, Quality Assurance, and Regulatory Affairs as part of their job function - includes employees in the following departments:
  • Production
  • Engineering & Validation
  • Facilities / Maintenance
  • Quality Assurance
  • Regulatory Affairs
Topic Background
Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, their product or a quality system. Given the fact that changes are inevitable, it is essential that companies have a compliant and effective change control program to ensure that no unnecessary or cGMP non-compliant changes occur. This Change Control training course will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough Change Control program; as well as, discuss the elements regarding successful management of an effective Change Control system.
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
View More