Quality Agreements and Their Role as Part of a Quality System
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 and Presenter Information
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 Type
Webcast
This event has no exhibitor/sponsor opportunities
When
Wed, Mar 19, 2025, 10:00am - 11:30am
PT
Cost
| Recording - Access for 6 months: | $249.00 |
Website
Click here to visit event website
Organizer
ComplianceOnline
