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

Applying Quality-by-Design (QbD) Concepts to a Stability Program – Fundamental Principles and Influential Factors in Stability Strategies

Live Web Training Courseliveondemandfinal
Instructor: Kim Huynh-Ba
Last Conducted on:
Wednesday, January 27, 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

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

Current Expectations in the Characterization & Comparability of Product Reference Standards for Biotechnology Products

Biotech - Live Web Training Courseliveondemandfinal
Instructor: Nadine M. Ritter, PhD
Last conducted on:
Monday, February 22, 2010

USP – Chapter 467- GMP Requirements for Testing Residual Solvents| Updated to include FDA Guidance of November 2009

Live Web Training Courseliveondemandfinal
Instructor: Nanda Subbarao, PhD
Last conducted on:
Tuesday, February 23, 2010

Comprehensive Forced Degradation Studies to Validate Stability–Indicating Methods for Biotechnology Products

Live Web Training Courseliveondemandfinal
Instructor: Nadine M. Ritter, PhD
Last Conducted on:
Monday, March 15, 2010

The Challenges of Developing and Validating Stability-Indicating Methods

cGMP trainingLive Web Training Course
Thursday, May 20, 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

The Challenges of Monitoring Impurities in Pharmaceutical Products – The Requirements in Q3 A/B and Key Factors in Setting Impurity Specifications

Live Web Training Courseliveondemandfinal
Last conducted on:
Friday June 25th 2010
(2:20 p.m. – 4:45 p.m. GMT)
Instructor: Kim Huynh-Bah


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

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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

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