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Quality Management Systems & The Future of MDSAP
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This half day event will feature 3 talks on Quality Management Systems & The Future of MDSAP.

 Export to Your Calendar 8/30/2017
When: Wednesday, August 30, 2017
Where: Map this event »
Arnall Golden Gregory LLP
171 17th Street NW
Suite 2100
Atlanta, Georgia  30363
United States

Online registration is available until: 8/30/2017
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 This Event is Presented By:

We understand the importance of proper auditing programs in the medical device field and the impact they have. The work we do today crosses countless borders and requires companies to adhere to vast sea of rules. These complicated hurdles require simple yet efficient programs to help mitigate and alleviate many problems. This half day event will feature 3 talks on Quality Management Systems & The Future of MDSAP.

Building Quality (Agreement) into Your Product
When it comes to making a quality product, it is advisable, if not expected, that companies will enter into agreements with third-party companies. The FDA has issued guidance on the value of quality agreements between contract manufacturers and companies.  The guidance also outlines the agency’s expectations on what should be included in such an agreement.    Counsel and RA/QA personnel should be aware of the agency’s current thinking.
In this session, we will:

•    Review the FDA guidance document and better understand agency expectations
•    Explore common areas of potential dispute between contract manufacturers and the sponsoring companies and practical tips to address these issues
•    Evaluate ways to minimize regulatory risk and business conflicts

Michael E. Burke, Partner, Arnall Golden Gregory
Alan G. Minsk, Partner & Food and Drug Practice Team Leader, Arnall Golden Gregory

Quality System Management: Requirements and Trends
Learn a unique perspective on Quality System Management from an organization responsible for the implementation and management of quality systems for numerous and varied medical device and biologic companies.  This session will provide an overview of the quality system requirements, helpful advice for specific components of the quality system, and enforcement trends.  The information in this session will be helpful for any business seeking to do business within the U.S. and/or internationally.

Linda Braddon, Ph.D., President, Secure BioMed Evaluations
Bryan Brosseau, Regulatory, Quality, Technical Support, Project Management, Secure BioMed Evaluations

Medical Device Single Audit Program (MDSAP): FDA - Health Canada - ANVISA - TGA -PMDA
The MDSAP program is endorsed by the International Medical Device Regulators Forum (IMDRF) and will be fully operational by late 2017 or early 2018.

The goal of the Medical Device Single Audit Program (MDSAP) is to provide for more effective, efficient and less burdensome regulatory oversight of the quality management systems of medical device manufacturers. The implementation of the MDSAP is intended to allow for a single audit to satisfy the regulatory requirements of the Participants.
In this session we will:
•    Discuss view points from industry leaders (Lead -- Halyard Health and others)
•    Lesson learned by a Pilot Program Participant (Halyard Health)
•    Evaluate the efficiency and consequences of this program for both the industry and regulatory bodies (Round table with Industry Participation)

Amar Chanani, Quality Manager, Halyard Health
Ujjal Chakravartty, Director Quality Systems, Halyard Health
Mizanu Kebede, VP Global Quality, Regulatory & Product Safety, Halyard Health
Manoj Karamchandani, CEO/President, Datalynx

Who Should Attend?
Executive and Management tier from:
•    Regulatory
•    Quality System
•    Quality Assurance
•    Audit

12:30-1:00pm     Registration Opens
1:00-1:15pm     Welcome
1:15-2:15pm    Building Quality (Agreement) into Your Product
2:15-3:45pm    Quality System Management  
3:45-4:15pm    Break
4:15-5:45pm    MDSAP
5:45-7:00pm     Reception  

GaBio & SEMDA Members  $40
Non-Member            $80

Includes beverages & appetizers.
Onsite registration is available.
Disclaimer: Cancellations must be received at least 48 hours in advance.

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Quality Management Systems & The Future of MDSAP

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