Issues & Methods Schedule 2011
Issues & Methods Schedule 2010
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Events:
Issues & Methods Roundtable Topics 2012
Date
Topic
Facilitator
Coordinator
January 10
Bring your Challenge – A roundtable dedicated to the issues that each attendee wants to discuss during the roundtable. Its goal is to share other members’ experiences and help attendees come with the best solution possible.
Evangelia Evdaimon
Evangelia Evdaimon
February 14
Document Control – What does this this really mean? What does it include and how is it accomplished? Review of letters posted on the FDA website related to Document Control issues.
Evangelia Evdaimon
Susan Meeker
March 13
Internal Audits – How do Management and the Auditee benefit? How does QA sell this?
Evangelia Evdaimon
Sabrena Lynn
April 10
21 CFR Part 11 impact and effectiveness on new technologies (i.e. iPad)
Evangelia Evdaimon
Lisa Olson
May 8
OECD GLP & Guidance on Pathology peer review: Do you follow OECD GLP? How has that changed your procedures?
Evangelia Evdaimon
Anita Simkins
June 12
Adverse Events – Drugs vs. Devices in the US
Dan Ozaki
Dan Ozaki
July 10
Quality and Working with Contract Manufacturers:
Cost, inconvenience, lack of time, mistrust of quality measures, and a fear of what assessment may find.
Evangelia Evdaimon
TBD
August 14
FDA Guidelines – Recent GCP Guidelines: Draft and Final in 2011
Evangelia Evdaimon
Beth Furr
September 11
SOPs – Writing or Enforcing: Which is the harder task?
Evangelia Evdaimon
Susan Meeker
October 9
EPA Standards Changes and Recommendations 2012
Evangelia Evdaimon
Rich Patterson
November 13
Drug Review Changes 2012: Discuss implemented or recommended regulatory changes in the drug review processes effective in 2012.
Evangelia Evdaimon
TBD
