September 30th, 2014

Understanding How FDA Looks at Outsourcing

When:  Thursday, October 9, 2014 at 6:00 PM

Where:  The Wyndham, 17941 Von Karman Ave., Irvine, CA 92614

The Southern California Pharmaceutical Discussion Group (SCPDG) of AAPS announces:

Understanding How FDA Looks at Outsourcing

Presented by

Marlène García Swider, Ph.D.

Quality System Manager for Los Angeles District Office, FDA.


Agenda: 6:00-6:30 PM networking, 6:30-7:15 PM dinner, 7:15-8:30 PM presentation and discussion

Registration: Please register via the Eventbrite link below by Oct. 6, 2014


Attendance is by pre-registration only – no walk-ins please.
Registration fee includes dinner, parking and presentation.  A cash bar is available but not included.

Working Professional (includes consultants)- $50

Working Professional/AAPS member-$40

Student (full-time)/ Retired/ Unemployed (no consultants) – $15

Abstract:  This presentation explains the regulatory challenges FDA encounters with current manufacturers outsourcing globally and the role and responsibilities for those participating in outsourcing of biotech products. Currently, many firms outsource parts of their manufacturing processes and services. Among the motivators to practice outsourcing, economics and faster product manufacturing play major roles. This new trend of doing business imposes new demands on FDA’s already limited resources. FDA wants to support every effort that would facilitate the approval of safe and quality products for the American public in United States. Therefore, it is important to gain a full understanding on the impact outsourcing has on the firms and on the FDA, along with the responsibilities for participants of these cooperative arrangements. This understanding can facilitate compliance with FDA regulations.

Biography:  Dr. Marlène García Swider has served in the FDA for more than 25 years in different capacities including Public Affairs Specialist (working with Congressional issues), Biotech Reviewer, Budget and Planning Analyst, Investigator, and Regulatory Project Manager. Most recently she serves as the Quality System Manager for Los Angeles District Office, FDA. She holds a bachelor degree in Science, a Masters in Health Services Administration and a Doctor degree on Organizational Management. She and her family reside in Orange County, California. This presentation is given in her own capacity as publisher of articles in the area of Global outsourcing and FDA. No official support or endorsement by the Food and Drug Administration is intended or should be inferred.

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Link to Google Maps for the Wyndham:,+CA+92614&hl=en&geocode=+&hnear=17941+Von+Karman+Ave,+Irvine,+California+92614&t=m&z=17


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