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.

Recorded Version Only

(PPT + Recorded Streaming Link)

1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: May-2024

Download File Only

(PPT + Recorded Training File)

Downloadable file is for usage in one location only.
(For multiple locations contact Customer Care)
Downloadable link along with the materials will be emailed within 2 business days
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Email: customercare@fdatrainingalert.com

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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
Instructor Profile:
Michael Ferrante Michael Ferrante

President, Quality and Compliance Associates LLC

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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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