Elements of an Effective Change Control 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 professionals 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.

His over 30 years’ experience encompasses both the traditional pharmaceutical industries as well as biotechnologies. This experience includes quality systems, pharmacovigilance, auditing, supplier qualification, R&D, clinical QA, validation, manufacturing/operations, regulatory affairs, facilities, and regulatory interactions.

During his career, Mr. Ferrante has successfully dealt with over 100 inspections by regulatory agencies, resolved warning letters, and prepared and controlled compliance plans. These interactions have occurred both domestically and internationally, since he has dealt in global operations in countries such as Australia, Netherlands, Sweden, Brazil, UK, Ireland, Germany, France, Switzerland, Italy, Czech Republic, India, China, Malaysia, and Thailand.

He has peer recognition for his accomplishments through leadership positions he has held in the Food, Drug, and Cosmetic Section of the American Society for Quality, as a former member of the ISO committee for Cleanroom Standards, and having served on the Editorial Board of the Journal of Validation. Mr. Ferrante has been asked to give presentations on a number of regulatory and quality topics by the American Society for Quality, the Parenteral Drug Association, International Society of Pharmaceutical Engineers, and the Institute for Validation Technology.

He has published a number of articles and was awarded Article of the Year by the Journal of Validation for his paper, “A Simple Way of Establishing Acceptance Criteria”. Mr. Ferrante holds a BA in Chemistry from Rutgers University, a MS in Chemistry from Fairleigh Dickinson University, and a MBA in Pharmaceutical Marketing from Fairleigh Dickinson University. He also holds certification from the American Society for Quality as a quality engineer and quality auditor.

Topic Background:

One of the key elements that must be addressed in any quality system is the control of changes. This has been shown time and time again by the issuance of regulatory observations that deal with changes that have not been adequately reviewed for impact on processes, facilities, equipment, specifications, and documentation. The list can go on but the essential element is to ensure there is an effective system to review and assess changes for impact on final product quality, safety, efficacy, and compliance.

It is important to note that without a well maintained and robust change control system, then quality and regulatory compliance will not be sustainable. For this reason, change control systems must be well defined, controlled, and effectively executed.

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