Quality Agreements and Their Role as Part of a Quality System

Speaker

Instructor: Michael Ferrante
Product ID: 706966

Location
  • Duration: 90 Min
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 TRAINING
Last Recorded Date: May-2024

 

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$329.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

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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.

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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. ComplianceOnline 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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

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