Quality Agreements Made Easy


Friday, September 14, 2018   |   10:00 AM PDT | 01:00 PM EDT   |   Duration: 60 Minutes      

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Duration: 60 Minutes  

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The webinar will explain that a good quality agreement may either reside in a file for years within a stable and well-working relationship, or else be revised frequently and vigorously within the context of a highly dynamic relationship in which the capabilities truly are evolving and expanding.
Shep Bentley   Product Id : 502081
  Instructor : Shep Bentley

  More Trainings by this Expert


Overview:

The requirements for the assurance of quality within networks and circles of entities whose responsibilities are increasing specialized present an especially vexing challenge to the managements of each of these organizations. The specification developer must be aware of the capabilities of the contract manufacturer and the contract manufacturer must be aware of the limitations of the specification developer, for example.

When other needful parties enter the relationship, such as critical or crucial suppliers, contract research organizations, test houses, and distributors, then need for a clear yet effective quality agreement may mean the difference between operating on luck and the skillful avoidance of litigation. Therefore, the webinar focuses upon the importance of the development of clear, complete, correct and current quality objectives, an approach to entering into a binding yet flexible quality arrangement, and most of all articulating the approaches to the most elemental portions of quality agreement drafting.

These areas of greatest interest between parties include the costs associated with exposure to liability, and the communication involved with these exposures, and the overall effect or potential effect on existing and future business between the parties. The importance of clear indemnification that follows existing applicable regulations and that does NOT impose unrealistic or unsupportable requirements that derive from the whimsy of the management of the other party is addressed in this webinar.

The need for explicit and balanced language that is in line with the best interests of all parties (both or multiple, as required) and the recognition of inappropriate requirements that could jeopardize the long term success of the relationship(s) form the basis of the content of the discussion. Inherent within the need to draft and accept such a document is a mutual understanding of real capabilities and real limitations, regardless of an idealistic view of the roles of each party.

The consequences of either exaggerated expectations in the present or wishful thinking about the future capabilities with the notion that these means of performance will catch up to the current agreement are unacceptable and to be avoided by a careful and meticulous reading of the appendices. The webinar will explain that a good quality agreement may either reside in a file for years within a stable and well-working relationship, or else be revised frequently and vigorously within the context of a highly dynamic relationship in which the capabilities truly are evolving and expanding.

The most important aspect of the quality agreement is accuracy of the content, as this document is subject to auditing by notified bodies and investigation by the FDA. The practical aspects of the webinar will include the understanding of what could be considered acceptable within any quality agreement as compared and contrasted to what verbiage represents warning signals within such an agreement, and finally what stands out as missing altogether as compared and contrasted to what should never be considered acceptable within any meaningful agreement.

Upon completion of the webinar, attendees should be able to contribute meaningfully to their parent organizations in the preparation and negotiation for acceptance of compliant and productive quality agreements.

Why should you Attend: To the extent that anyone responsible within a specification developer, contract design organization, purchasing organization, supplier of critical or crucial materials or services, or contract manufacturing and/or testing organization is concerned about conformity to the ISO 13485:2016 or compliance to the FDA regulations and imminent European Medical Device Regulation, this webinar is for you. The consequences are not simply business related, but could presently result in the preferring of criminal charges against the management of any organization that could be shown to have disregarded the requirements for quality under the law.

While the United States of America has known the full weight of the law enforcement capacity of the Food and Drug Administration for greater than a century, only now in the European Union has the Medical Device Regulation begun to supersede the use if the Medical Device Directive. It may seem to be a herculean task to comprehend and to craft a document that provides an organization a fair and effective agreement in line with its desired relationship to its partners in the development and production of safe and effective medical devices, but the effort need not be a source of frustration or fear.

With an hour of instruction and summary of the most essential elements of the creation of a meaningful and durable agreement, the achievement of this needful item of compliance and conformity will come into sharp focus and be doable. Only by taking the time before it is too late will this exercise appear manageable and disarming, and provide a sense of peace of mind to those who need it the most.

Areas Covered in the Session:

  • What is the basis of any quality agreement?
  • What are the applicable regulations for quality agreements?
  • How important is it to my organization to have a quality agreement?
  • What are the consequences of mistakes in quality agreements?
  • How hard does drafting a meaningful quality agreement have to be?
  • What do regulators look for in these quality agreements?
  • How often should a quality agreement be reviewed? Revised?
  • What if I cannot achieve agreement with the other party?
  • Tips for making a quality agreement acceptable to all

Who Will Benefit:
  • Regulatory Management
  • Regulatory Consultants
  • Quality Management
  • Sales & Marketing Management
  • Scientific Staff (Advisors)
  • Clinical Staff (Advisors)
  • Research & Development Management
  • Top Management (CEO, COO, CFO)


Speaker Profile
Shep Bentley is the President and Principal Consultant for Bentley Biomedical Consulting, LLC, where he is responsible for regulatory strategies leading to FDA approvals and clearances for digital medical device companies. Shep began his career in 1984 at the Hospital Corporation of America as a research technician, and worked at McGaw Labs in Irvine, responsible for GMPs until 1989, when he joined TOSHIBA America where he managed production of various digital devices. He founded Rising Star, a contract manufacturer for digital medical assemblies in 1993, and sold it in 1997 to Standard Industries in Anaheim. He was a founder of Volcano Therapeutics, Inc. in 2001, which was acquired by Philips in 2015.

For the past fourteen years since 2004 as an independent consultant, Shep has worked to achieve device approvals and clearances from the FDA, and market entry for numerous innovative medical technologies and applications within the European Union, Canada, Brazil and across Asia. He speaks regularly at regulatory conferences, has just co-authored a book on device approval and provides independent consulting for clients of Intertek. He is a graduate of The University of The South, and has studied international literature at the Johannes Gutenberg University in Mainz, Germany. He is a member of AAMI, ASQ, RAPS, TOPRA and on the Program Committee of the Orange County Regulatory Affairs (OCRA) Discussion Group. He has been a featured speaker on the topic of cybersecurity for the past two years at the FDA Annual Meeting, and the Medtech Monday events in California.




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