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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
1:00pm-7:00pm
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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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

 

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.

 

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)

 

Speakers Include:

Amar Chanani, Quality Manager, Halyard Health

Ujjal Chakravartty, Director Quality Systems, Halyard Health

Mizanu Kebede, VP Global Quality, Regulatory & Product Safety

 

DATE

Wednesday, August 30, 2017

 

TIME

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

 

LOCATION

Arnall Golden Gregory LLP
171 17th Street NW, Suite 2100
Atlanta, GA 30363

http://www.agg.com/Atlanta/

 

REGISTRATION

GaBio & SEMDA Members       $40

Non-Member                             $80

 

Includes beverages & appetizers.

Onsite registration is available.

 

Cancellations must be received at least 48 hours in advance. 

 

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