RSVP today to attend any or all of these sessions FREE of charge.
Download the Quality Assurance and Regulatory Affairs brochure. RSVP today to attend any or all of these sessions.
QA & RA professionals at all levels, non-QA & RA employees of companies who would benefit from a better understanding of quality and regulatory affairs, and students who may want to enter these professions are all welcome. This series will be conducted by local professionals to benefit area companies and individuals and help built a network for discussion and support in the Alachua/Gainesville, Florida area. RSVP to Shannon Hester at shester@sidmartinbio.org. For questions contact Patti Breedlove at pbreedlove@sidmartinbio.org or 386-462-0880.
WORKSHOP SERIES
Communicating with the FDA
The goal of this panel presentation, and open discussion with the audience, is to increase understanding of how to communicate with the FDA through both formal and informal channels. Although it is expected that all communications with the FDA is formal, the reviewers at the FDA expect informal communications also. Panel members, who are local QA & RA experts, have worked with FDA staff in district offices and with CBER and CDRH in Washington. They will share their real-world experiences with site audits, product approvals/clearance negotiations and other mechanisms such as Request for Designation submissions and IND/IDE submissions.
Monday, November 5, 2012
3:00 PM – 4:30 PM
SF Perry Center, Alachua, FL
Panel:
Mark Friedman, VP of QA/RA, AxoGen Inc., Tissues and Biologics
Gregg Ritter, RA Consultant, Medical Devices
Paula Wilkerson, RAC, CRA-FDA Accredited Person, Medical Devices
Al Fosmoe II, Integrated Reg-Ops Consulting: Drugs/Medical Devices/Biologics
Alphabet Soup of Acronyms
The goal of this short course is to introduce quality and regulatory personnel to the world of acronyms that are common to the biopharmaceutical, blood, regenerative medicine and medical device world. These acronyms will include GCP, GTP, GLP, GMP, ISO (Design Controls), QSR (Design Controls), ICH. You will learn what these stand for, why they are necessary, what industries they pertain to, what you have to do to comply with the regulations surrounding these acronyms and how to get information on the standards pertaining to the acronyms.
Tuesday, December 4, 2012
3:00 PM – 4:30 PM
SF CIED Center, Gainesville, FL
Knowledge Room (DB-117)
Instructor:
Ty Hutchinson, Tekvise International, LLC
Tools for Validation
The goal of this short course is to discuss the tools that are needed to have a robust design validation system and a process validation system. Discussion will center around the differences between design and process validation, what standards are available to help you understand the requirements of validation, what statistical understanding is required and how does design/process validation differ between the different industries of Pharma, Biologics, Tissues and Medical Devices.
Tuesday, January 15, 2013
3:00 PM – 4:30 PM
SF Perry Center, Alachua, FL
Speakers:
Kevin Engemann, QA Manager, AxoGen
Mark Friedman, VP of QA/RA, AxoGen Inc. Tissues and Biologics
What to Do When FDA Comes Knocking
The goal of this short course is to help you prepare your company for local FDA inspections, know how to conduct yourself during an audit and respond to the audit results. The instructors have been through inspections with the FDA and will discuss their experiences with preparation, audit conduct and responding to FD483 Observations and Warning Letters. Also learn how to get your establishments audit report from the FDA.
Wednesday, February 20th, 2013
3:00 PM – 4:30 PM
SF CIED Center, Gainesville, FL
Knowledge Room (DB-117)
Panel:
Al Fosmoe II, Integrated Reg-Ops Consulting: Drugs/Medical Devices/Biologics
Susan Wray, Consultant, Vilano Associates
Darren Kahn, Director of Operations, RGI Medical
