Good Monitoring Practices for Medical Devices

Live Web Training Courseliveondemandfinal

Instructor: Robert Russell

Selection of Lead Compounds for Successful Development of Marketed Products

Live Web Training CoursecGMP training
Friday, September 17, 2010
(1:20 p.m. – 3:45 p.m. EDT)Course Details
(12:20 p.m. – 2:45 p.m. CDT)
(10:20 a.m. – 12:45 p.m. PDT)Pricing
Instructor: Dr. Surendra Mehta

Blood borne Pathogens & Universal Precautions - Annual Safety Training

Live Web Training CoursecGMP training
Thursday, September 23, 2010
(1:20 p.m. – 3:45 p.m. EDT)Course Details
(12:20 p.m. – 2:45 p.m. CDT)
(10:20 a.m. – 12:45 p.m. PDT)Pricing
Instructor:Charles Gyecsek

Registration is now open!

HEPA Filter Testing & Certification for Clean Room Environments

Live Web Training CoursecGMP training
Thursday, October 28, 2010
(1:20 p.m. – 3:45 p.m. EDT)Course Details
(12:20 p.m. – 2:45 p.m. CDT)
(10:20 a.m. – 12:45 p.m. PDT)Pricing
Instructor:Charles Gyecsek

New Topic: Registration is now open!

Analytical Expectations in Characterization and Comparability Studies of Biotechnology Products and Emerging Biosimilars

Live Web Training CourseRegistration
Wednesday, September 15, 2010
(1:20 p.m. – 3:30 p.m. EDT)Course Details
(12:20 p.m. – 2:30 p.m. CDT)
(10:20 a.m. – 12:30 p.m. PDT)GLP
Instructor: Nadine M. Ritter, PhD

“Raw Material Requirements (USP/EP) in a cGMP Environment -- Issues and Solutions from Phase 1 Through Commercial”

Live Web Training Course
Last conducted on:
Wednesday, July 14, 2010liveondemandfinal
Instructor: Barry A. Friedman, PhD

“The EU Medical Device Changing Regulatory Landscape; 2010 Changes and the Impact of Current Rewrites in 2011-12”

Live Web Training Courseliveondemandfinal
Last conducted on:
Tuesday, July 6, 2010
Instructor: Robert J. Russell

The EU IMPD (Investigational Medicinal Product Dossier); Comparing the CTA and IND Applications Content


Live Web Training Courseliveondemandfinal
Last Conducted on:
Tuesday, July 27, 2010
(10:20 a.m. – 12:30 p.m. PDT)
 Instructor: Robert J. Russell

Clinical Product Development: From Pre-IND to BLA/NDA

Live Web Training Course
Instructor: Julia Barrett M.D., MPHliveondemandfinal

Strategies for Ensuring Regulatory and cGMP Compliance of Outsourced Stability Programs

cGMP trainingLive Web Training Course
Tuesday, September 21, 2010
(1:20 p.m. – 3:45 p.m. EDT)Course Details
(12:20 p.m. – 2:45 p.m. CDT)
(10:20 a.m. – 12:45 p.m. PDT)Pricing
Instructor: Kim Huynh-Ba

Selection and Validation of Commercial and Custom Host Cell Protein Assays for Biotechnology Products

Live Web Training CourseRegistration
Tuesday, October 5, 2010
(1:20 p.m. – 3:30 p.m. EDT)Course Details
(12:20 p.m. – 2:30 p.m. CDT)
(10:20 a.m. – 12:30 p.m. PDT)GLP
Instructor: Nadine M. Ritter, PhD

Conducting Successful OOS/OOT Investigations for Analytical Testing

cGMP training3-Session Live Web Training:
Session 1: Tuesday, October 19, 2010
Session 2: Thursday, October 21, 2010Course Details
Session 3: Tuesday, October 26, 2010
(1:20 p.m. - 3:30 p.m. EDT)Pricing
(12:20 p.m. - 2:30 p.m. CDT)
(10:20 p.m. - 12:30 p.m. PDT)
Instructor: Kim Huynh-Ba

Registration is open... spaces filling up quickly!

Latin America – Understanding the Structure, Regulatory Requirements and Compliance Processes for the Pharmaceutical, Biotech and Medical Device Industries

2-Session Live Web Training:
Session 1: Monday, September 13, 2010 cGMP training
Session 2: Monday, September 27, 2010
(11:30 a.m. EDT/GMT-5/ - 2:30 p.m. EDT/GMT-5)Course Details
(10:30 a.m. CDT - 1:30 p.m. CDT)
GLP(8:30 a.m. PDT - 11:30 p.m. PDT)
Instructor: Robert J. Russell

Change Control Management for a Stability Program – Potential Changes and Minimizing the Impact of Registration

Live Web Training Courseliveondemandfinal
Instructor: Kim Huynh-Ba
Last Conducted on:
Tuesday, August 10, 2010

Complying with cGMPs in the Manufacturing of Clinical Trial Materials – From Phase 1 Through Phase 3 (With Emphasis on Phase 1)

Live Web Training Courseliveondemandfinal
Instructor: Barry A. Friedman, PhD
Last Conducted on:
Tuesday, January 26, 2010