Elements of an Effective Change Control System

This webinar will focus on the regulatory and design requirements for an effective change control system. Attendees will learn role and importance of change control system in implementing an effective quality system.

Why Should You Attend:

An effective change control system is one of the cornerstones of a productive organizational quality system. Change control can be instrumental in ensuring continuous control over changes to facilities, equipment, processes, specifications, and laboratory operations, etc.

The importance of change control is emphasized by how it is stressed in regulatory inspections (FDA, EU, TGA, etc.) and in regulatory requirements. There are specific change control elements in cGMPs, ICH, and ISO requirements. All these are critical components of the latest regulatory guidelines on the implementation of quality systems.

This webinar will help attendees understand the critical role that change control has in the successful implementation of a quality system and how it can be a vital element in achieving quality and ensuring regulatory compliance.

Areas Covered in the Webinar:

• Change control’s role in an effective quality system
• Specific regulatory requirement for change control
  • ICH guidelines and Good Manufacturing Practices
• Guidelines on change control’s role in regulatory inspections
• Specific design requirements for a change control system
• Key aspects of the role and key players involved in a change control system
• Common problems encountered in change control
• Recent regulatory trends and observations.

Who will benefit:

• Pharmaceutical Professional involved in the manufacture of products
• API and Excipients Providers
• Service Providers
• All Levels of Management
• Change Control Professionals
• Quality Professionals

Instructor Profile:

Mr. Michael Ferrante, possesses a unique background in the field of pharmaceutical and biotechnology quality and compliance. Mr. Ferrante has held middle and senior management positions with companies such as Mayne Pharma, Schering-Plough, Glaxo Wellcome, Burroughs Wellcome, and Organon, Currently, he is President of Quality and Compliance Associates LLC, which provides consulting expertise to the pharmaceutical and healthcare industries regarding quality systems, regulatory compliance, FDA Interactions, and organizational evaluations and improvements.