Quality Agreements and Their Role as Part of a Quality System

Name: Quality Agreements and Their Role as Part of a Quality System
Start: 2025-03-19
End: 2025-03-19

This webinar will focus on the Process for Quality Agreements and requirements that must be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn the reason for implementing a Quality Agreement system to assure adequate controls for Service Providers.

Areas Covered in the Webinar:

Regulatory Requirements for Quality Agreements
Defining the Purpose of Quality Agreements
Different Types of Quality Agreements with Service Providers
Definition of Roles Between the Manufacturer and Service Providers
Regulatory Roles in the Quality Agreement
Expectations for Quality Agreements in Regulatory Inspections.
Benefits of Quality Agreements from Both a Regulatory and Quality Perspective
Enforcement of Quality Agreements
Monitoring of Agreements.

Who Will Benefit:

Pharmaceutical Professionals
All levels of management
Compliance management
Regulatory Affairs Management
Manufacturing Professionals
Service Providers
Laboratory Professionals
R&D Professionals
Quality Professionals

Speaker Details

Mr. Ferrante is President of Quality and Compliance Associates LLC and has over 40 years experience in the pharmaceutical and biotechnology fields. This experience encompasses quality systems, laboratories, R&D, clinical QA, validation, manufacturing/operations, regulatory affairs, and facilities covering all dosage forms.

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

He has held middle to senior management positions in startup to Fortune 100 companies up to the level of VP of Quality Systems and Compliance. 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 articles in the Journal of Validation and Journal of Compliance.

Event Topic

Healthcare, Medical, Risk Management/Regulatory