FDAnews Announces — The 24 Elements You Need For a World-Class Quality Agreement Webinar, Jan. 27, 2016

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Supplier quality is a fundamental topic of perennial importance. Agreements with suppliers must be written and executed to cover every possible contingency and ensure that the materials that go into the products are exactly what is required and are available when needed.

The 24 Elements You Need For a World-Class Quality Agreement
Jan. 27, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/24elements

Supplier quality is a fundamental topic of perennial importance. Agreements with suppliers must be written and executed to cover every possible contingency and ensure that the materials that go into the products are exactly what is required and are available when needed. Today’s minor mistake by a supplier could easily turn into tomorrow’s major recall. And if manuacturers don’t catch all the oversights in a quality agreement, odds are the FDA will.

On Jan. 27 join Steven Sharf, a 20-year industry veteran who has managed thousands of suppliers for companies like Merck and Novartis, as he explains the 24 elements that must be included in a quality agreement.

Attendees will not only learn what the 24 elements are but they will also learn:

  •     The importance of clearly defined roles in the complaint handling / adverse event reporting process
  •     The need for a responsibility matrix to clearly identify what entity is responsible for what quality function
  •     How many samples should the agreement require to be retained?
  •     Subcontracting and whether a company should allow it at the discretion of the subcontractor

Don't think that because there is no explicit (FDA) requirement for auditing suppliers that manufacturers won't get written up in a heartbeat for not having a robust audit program and quality audits of suppliers.

Meet the Presenter:
Steven Sharf, ASQ-CQA, CPGP
Senior Consultant, Validant

Steven Sharf has spent over 20 years in the pharmaceutical industry working on supplier quality management for such companies as Novartis, Merck, and Schering-Plough. Prior to coming on as Senior Quality Consultant for Validant, he was president of GMP Concepts and GMP Technical Director for SQA Services. He has managed multiple regions simultaneously covering thousands of suppliers and over a hundred auditors, and has worked on multiple consent decrees as an assessor/inspector and a verifier. He has presented on numerous occasions to different industry groups regarding the principles and philosophies he employs when evaluating suppliers and audit programs in general.

Who Will Benefit:

  •     Auditors
  •     Compliance officers
  •     Engineering and design controls teams
  •     Executive management
  •     Managers
  •     Manufacturing directors and supervisors
  •     Pharmaceutical and cGMP auditors
  •     QA/QC personnel
  •     Risk management specialists
  •     Strategic planning and business development staff
  •     Validation specialists, scientists, engineers

Webinar Details:
The 24 Elements You Need For a World-Class Quality Agreement
Jan. 27, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/24elements

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/24elements
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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