Establishing an Effective Change Control Program


Thursday, January 24, 2019   |   10:00 AM PST | 01:00 PM EST   |   Duration: 90 Minutes      

Live

One Dial-in One Attendee

Price: US$150.00


Corporate Live

Any number of participants

Price:US$290.00


Duration: 90 Minutes  

Recorded

Access recorded version,
only for one participant ?

Price: US$190.00

Corporate Recorded

Access recorded version,
Any number of participants ?

Price: US$390.00

In this webinar Attendees will learn how to develop, implement and manage a GMP compliant change control program. Attendees will also receive an example Change Control SOP and form template as reference guides.
Kelly Thomas   Product Id : 502326
  Instructor : Kelly Thomas

  More Trainings by this Expert


Overview:

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.

Attendees will learn how to develop, implement and manage a GMP compliant change control program.

Attendees will also receive an example Change Control SOP and form template as reference guides.

Why should you Attend: 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

Areas Covered in the Session:
  • 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

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


Speaker Profile
Kelly 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.




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