WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,

FL,

US,

ZIP: 33021

Phone: 844-267-7299 | 954-947-5671  

Overview
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 an effective Change Control system.

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Session Highlights
Topic 1: Regulatory Guidance Review

• FDA (CFR)
• EU (EurdraLex)
• ICH Q10

Topic 2: 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

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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.
• 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

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Speaker

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. 


Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671  
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