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Course and Conferences: Presentations and Observations


DIA Conference: Switzerland, 2011

Presentation by Dr. Teri Stokes on October 11th

Auditing Case for IVR Systems –Randomization & Supplies, Phase IV, ePRO, eCRF

 

Conference Impressions

This was an enthusiastic conference. Presentations were kept to 20 minutes each and lively question and answer discussions of presented topics filled the last 20 minutes. Some sessions included workshops with two presentations followed by group activities. One such was “Internal Audits – Driving Quality Standards and Compliance?” Five working groups addressed different phases in the life cycle of an internal audit.

Attendees especially responded to two plenary sessions.

  • Tuesday afternoon’s debate that “This House Believes that Clinical Research has Lost Customer Confidence.” Audience voting at the start agreed with the premise. After the debate, attendees still agreed with it. The Age of the e-Patient has arrived. Reaching and recruiting that e-Patient will require skillful use of social media by clinical research.

  • Wednesday’s closing Session “Impact of Social Media on the Pharmaceutical Sector” had a panel of pharmaceutical media experts discuss practical issues around the use and abuse of medical information and drug products in social media. Harnessing the social media’s capacity for promoting action in support of company products, correct medical information, and pharmaceutical industry image is an important imperative for the next 3-5 years.




GMP Conference: Dubai UAE, 2010

 
Date:

February 21-23, 2010


Event:

3 rd Pharmaceutical & Biotech GMP Conference – Dubai, United Arab Emirates
Speaker: Teri Stokes, Ph.D., Director GXP International
Topics:

Monday, Feb.23, 2010 at 3:15-5:30 PM

Computer and Software Validation Course

  • Global Regulations and Common Compliance Themes
  • How to perform OQ/IQ/PQ Validation as Supplier, IT support, and End User
  • Work Case Study – Walk-through of validation package for an LC/MS laboratory system

Tuesday, Feb. 24, 2010 at 9:00-11:00 AM

Computer and Software Validation Course (course continues)

  • Formal Testing Practices for Auditable Test results
Case Study #2 – Walkthrough of actual test documentation to explore roles and structure of various test documents.

Location:

Grand Hyatt Dubai, Dubai, United Arab Emirates



 

 
Dr. Teri Stokes GXP International 131 Sudbury Road Concord, MA 01742 USA Tel: +1-781-354-3537
Fax: +1-978-369-5620 Email: drstokes@gxpinternational.com
 
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