Japan – Understanding the Structure, Regulatory Requirements and Compliance Processes for the Pharmaceutical, Medical Device and Biotech Industries - 2-Session Live Web Training Course

Live Web Training Course
Last conducted on:liveondemandfinal
Session 1: May 11, 2009
Session 2: May 15, 2009
Instructor: Robert J. Russell

Developing an ICH-Compliant Stability Program for Drug Products and API – A Review of Regulations, Guidelines, Protocols and Strategies

Live Web Training Courseliveondemandfinal
Instructor: Kim Huynh-Ba
Last Conducted on:
Thursday, January 21, 2010

Recent Developments in the WHO Vaccine Stability Guidance – Key Definitions, Principles, Requirements and a Comparison of Traditional and New Methods for Stability Testing

Live Web Training Courseliveondemandfinal
Instructor: Nanda Subbarao, PhD
Last conducted on:
Tuesday, 30th March 2010

Good Documentation Practices Preface for the Pharmaceutical Laboratory

Live Web Training Courseliveondemandfinal
Instructor: Kerry P. Potter

2010 Changes to the EU Variation Rules, Classifications and Submittal Requirements

Live Web Training Courseliveondemandfinal
 Last conducted on:
Monday, June 21, 2010

Instructor: Robert J. Russell

β€œThe 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

Stability Studies for Biologics and Therapeutics: A Regulatory Perspective on Requirements, Equipment, Supporting Systems and Forced Degradation

Live Web Training CoursecGMP training
Wednesday, August 18, 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: Nanda Subbarao, PhD

Annual GMP Training – Exploring Good Manufacturing Practices Updates and FDA Regulatory Expectations

Live Web Training II Part Course cGMP training
PART I: Thursday, October 7, 2010
PART II: Thursday, October 14, 2010Course Details
(1:20 p.m. – 3:45 p.m. EDT)
(12:20 p.m. – 2:45 p.m. CDT)
(10:20 a.m. – 12:45 p.m. PDT)Pricing
Instructor: Barry A. Friedman

Featured in October, Early Birds Save!

Good Monitoring Practices for Medical Devices

Live Web Training Courseliveondemandfinal

Instructor: Robert Russell

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

Annual GMP Training – Canadian Regulations - 2009 GMP Edition, Changes & Interpretation

Registration

Live Web Training Course
Session 1: Thursday, September 9, 2010
Session 2: Thursday, September 16, 2010Course Details
(1:15 p.m. – 3:30 p.m. EDT)
(12:15 p.m. – 2:30 p.m. CDT)Pricing
(10:15 a.m. – 12:30 p.m. PDT)
 Instructor: Normand Robichaud, M.Sc.

(disponible sur demand en Francais)

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

Air Flow Visualization Studies in Support of Aseptic Manufacturing

Live Web Training Course
Tuesday, October 12, 2010cGMP training
(1:15 p.m. – 3:30 p.m. EDT)
(12:15 p.m. – 2:30 p.m. CDT)Course Details
(10:15 a.m. – 12:30 p.m. PDT)
Instructor: Charles S. LevinePricing