FDANews: Quality Metrics: Essential to Quality

1st Annual Quality Management vSummit: Optimizing Your Quality Management Program to be FDA-Compliant.

Session Summary:
Learn more about the best practices for measuring quality, rating your QM program, and auditing implementation.

RCA Speaker:
Seyed Khorashahi, Executive Vice President of Medical Device and CTO, has more than 25 years of experience leading research and development teams in all aspects of creating safety-critical medical devices. He has held leadership positions at Covidien (Medtronic), Baxter, and Beckman Coulter, Inc. and he has an extensive background in medical device product development, quality systems, regulatory affairs, mergers and acquisitions, engineering, and business strategy. He returned to Regulatory Compliance Associates (RCA) in 2015 as COO and now works in conjunction with the CEO and Board of Directors to define operational and technical strategy, as well as plan and develop the primary processes to support client service delivery.

Steven Lynn, MS, RCA's Executive Pharmaceutical Consultant, has more than 20 years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries. Joining RCA in September 2020, Steven serves as executive vice president of pharmaceuticals. Prior to joining RCA, he served in executive leadership roles with global accountability in the private sector as well as at the FDA. While at the agency, he was the director of CDER’s Office of Manufacturing and Product Quality. In this role, he was responsible for the global oversight of all drugs manufactured and/or imported into the U.S. In addition, in his last year at the FDA, he also served as the operations transition lead for CDER’s new Office of Pharmaceutical Quality.

About RCA

RCA provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

Pharmaceutical
Biologic & Biotechnology
Sterile compounding
Medical device
Lab Testing

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience

www.rcainc.com