PMI Atlanta Chapter - Healthcare Forum - 170517

Healthcare Forum - 170517

The PMI Atlanta Healthcare Forum has 9 planned sessions throughout 2017. Proposed topics include IT & IT PMO in Healthcare, Healthcare SME/Domain Forums such as Clinical, Laboratory, Research, Tomorrow's Healthcare & Government practices/law, Thought Leadership in Healthcare, and Innovation in Healthcare Technology.

Keynote Presentation:  "The FDA Moved My Cheese: Leveraging Quality and Regulatory Resources to Keep the Project On-Track” presented by Melissa Gaynor O’Connor M.S., RAC

 

Light refreshments and beverages will be provided.

Earn one PDU for attending this event.

When
Wednesday, May 17, 2017
6:00 PM - 8:00 PM

Where
Philips Healthcare
13560 Morris Road
PHA University Room
Alpharetta, Georgia 30004
770-510-1444

Fees
PMI Atlanta Member: $12.00, Early Bird Rate $10.00 through May 10th
Non-Member: $15.00, Early Bird Rate $13.00 through May 10th

Please note: Effective May 2016, Forums will no longer accept cash registrations at the door.  Please register in advance or via credit card at the door.

Meeting content, presenter, and location are subject to change. Refunds will not be made for changes in meeting content, presenters, or locations. 


Presentation Details:

On the project timeline, it seems like FDA pre-market approval is a deliverable outside of the project team’s control. How do we manage a milestone on the critical path that is owned by a team member that is not part of our organization? The regulations explain the statutory timelines, but the Quality System Regulations provide the tools we need to ensure the output of our development efforts will be accepted by the Agency and prevent unnecessary slips in the timeline. Melissa O’Connor, Vice President of Quality Assurance and Regulatory Affairs for StimLabs, LLC., will discuss some of the pit-falls commonly encountered by product development teams when developing products in the regulated environment and how to use the tools provided by the statutes to develop and execute a realistic timeline.

By attending this presentation, the project manager will gain an understanding of the FDA’s pre-market approval pathways for regulated products, so that realistic timelines can be developed and communicated to key stakeholders within the organization. A brief overview of the FDA’s General Controls for Medical Devices will be presented, with a focused explanation of the Quality System Regulation (21 CFR 820) and how Quality Management Systems for Medical Device companies are built to meet the intent of the QSR. Melissa will discuss how to use key subsystems of the Quality Management System to ensure the output of product development projects will meet FDA expectations culminating in a successful, on-time pre-market approval and product launch.

Talent Triangle Category: Leadership


Harvey-MagalineMelissa Gaynor O’Connor, M.S., RAC has 16 years of experience in medical device, combination product, and human tissue new product development research, engineering, and commercialization. She currently holds the position of Vice President of Quality Assurance and Regulatory Affairs for StimLabs, LLC, a regenerative medicine company specializing in the processing of human tissue. Melissa is also a consultant for REGSolutions, LLC., a boutique consulting firm providing regulatory solutions and quality systems for the medical device industry.

Melissa has over 6 years of experience in Quality System design, implementation, maintenance, and compliance. Prior to joining StimLabs, Melissa held Quality leadership positions serving as the Management Representative, Head of Quality, and Official FDA correspondent for prescription eye-glass lens manufacturer QSpex Technologies, Inc., and Chemence Medical Products, Inc., a global manufacturer of adhesive based Class II medical devices for wound closure. Melissa began her career at Kimberly-Clark Health Care, where she held positions in Regulatory Affairs, Product Development, and Process Engineering over her 11 year tenure. Her work in medical device product development for Kimberly-Clark resulted in the issuance of 4 US patents and the commercialization of several new surgical and infection control products. In addition to Quality Systems expertise, Melissa is skilled at developing comprehensive regulatory strategies to support new product development including pre-market approval requirements for the U.S and E.U.

Melissa is a member of the Regulatory Affairs Professional Society (RAPS) and holds an active RAC certification. She is an active Chapter Leader for the RAPS Atlanta Chapter and participates in planning for local events. Melissa holds a BS degree in Biological Sciences from the University of Georgia and a MS Degree from the University of Georgia School of Pharmacy in Biomedical and Pharmaceutical Regulatory Affairs. Outside of work, Melissa is a competitive horseback rider and recently achieved a personal milestone by earning her Bronze Medal Rider Award from the United States Dressage Federation.

Logging PDUs:

PDUs can be claimed here.

For detailed instructions, please visit the CCRS User Guide.

Event Properties

Event Date 05-17-2017 6:00 pm
Individual Price $15.00
Location Philips Healthcare

We are no longer accepting registration for this event