Qualification and Audit of Suppliers and Vendors - A Risk Based Approach

Instructor: Michelle Sceppa
Product ID: 701189
  • Duration: 90 Min
This Pharmaceutical compliance training will demonstrate how to implement an effective audit program for both manufacturing and the laboratory and the ability to maintain GMP/GLP/GCP compliance with all suppliers and/or vendors.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Mar-2009

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

When companies use suppliers and vendors Regulatory Agencies will hold your company responsible for ensuring that any outsourced services are done in compliance to regulatory standards. Therefore, your company is responsible for all the actions of your suppliers and/or vendors. This webinar will demonstrate how to implement an effective audit program for both manufacturing and the laboratory. The webinar will provide the listener with the ability to maintain GMP/GLP/GCP compliance with all suppliers and/or vendors.

Areas Covered in the seminar:

  • The components of a Supplier/Vendor Qualification/Audit program.
  • The Regulatory requirements of a Supplier/Vendor Qualification/Audi program.
  • The differences between a Qualification Audit and a Standard Audit.
  • Implementing a Supplier/Vendor Qualification/Audit program.
  • Performing the audit(s).
  • Documentation associated with the audit(s).
  • Supplier/Vendor disqualification.
  • Regulatory expectations; recent FDA inspectional observations & how to avoid common pitfalls.

Who will benefit:
This webinar will provide instruction on how to establish and maintain a Supplier and Vendor program for the pharmaceutical and Biotechnology Industry. It is a critical requirement for "virtual" companies.

  • Managers
  • Supervisors and Associates in the Pharamceutical Industry that have daily responsibilities in Quality Assurance
  • Quality Control, Compliance and Manufacuring

Instructor Profile:
Michelle Sceppa, is the Principal at MSceppa Consulting, an establish Consulting firm and is in its 12thth year in the Industry that specializes in quality systems for Pharmaceutical and Biotechnology interests. MSceppa Consulting has implemented and managed Preclinical, Clinical, and Manufacturing Quality Assurance Programs for numerous clients. As the lead auditor, MSceppa Consulting has conducted and managed more than 400 internal and external vendor audits for Drug and Biologic firms in the US and Europe. MSceppa Consulting is knowledgeable in the details of compliance with all U.S. Federal Regulations-Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) for Drugs, Biologics and Medical Devices.

Follow us :
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
Latin America: Regulatory Compliance Requirements for Life Science Products

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. 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.

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@complianceonline.com call +1-888-717-2436 (Toll Free).

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