| Issues & Methods Schedule 2010 |
| Date |
Topic |
Facilitator |
Coordinator |
| January 12 |
21 CFR Part 11 & GcP Relation |
Lisa Olson, Director, Computer System Quality, Quality Assurance i3 |
Evangelia Evdaimon |
| February 9 |
Quality Assurance in ClinicalTrialOrganizations & the Role Responsibility of a Principal Investigator as per GCP |
Jenny O'Brien, PhD, RAC, RQAP-GCP
Associate Director, GCP Services Falcon Consulting Group, LLC |
Evangelia Evdaimon |
| March 9 |
GLP CRO Evaluation – What to look for |
Rich Patterson |
Evangelia Evdaimon |
| April 13 |
How to help people who do not have a GxP background, understand what it is, basic concepts we take for granted. How do we get them to understand & how to say “No” the quality way? |
Sabrena Lynn, Liposcience |
Evangelia Evdaimon |
| May 11 |
Outsourcing of outsourcing - when your vendor uses a vendor: risks, controls, oversight. |
Beth Furr, Quintiles |
Evangelia Evdaimon |
| June 8 |
Regulatory inspections/actions. - Audit tactics/techniques (how do you determine/decide on a sample, how do you do document review without getting buried, review of documents electronically.) |
Anita Simkins, Quintiles |
Evangelia Evdaimon |
| July 13 |
How do things like authority, influence, agreement, collaboration, interactions manifest themselves in different cultures? What assumptions do we make? |
Marcella Sarzotti-Kelsoe, Duke |
Evangelia Evdaimon |
| August 10 |
Process Validation & Method Validation – Challenges & Solutions |
Richard Patterson |
Evangelia Evdaimon |
| September 14 |
Total Disclosure Audits and Risk Management |
Rita Geiger, InfoStrength, Inc. |
Evangelia Evdaimon |
| October 12 |
Use of the web in regulated industry - data collection, study randomization, subject interaction, reporting of adverse events by the public, etc. - Issues with compliance - what should QA reasonably expect? |
TBD |
Evangelia Evdaimon |
| November 9 |
Fundamentals of medical devices |
Jenny O'Brien, PhD, RAC, RQAP-GCP
Associate Director, GCP Services Falcon Consulting Group, LLC |
Evangelia Evdaimon |
