Biopharma & Parenterals

The rise of biologics has been a well documented phenomenon, with large pharmaceutical companies scaling up their respective biologics departments, and major mergers taking place on a regular basis. The exponential increase in the number of biologic products entering the marketplace has given rise to a host of new regulatory concerns.

As part of our continuous effort to present content devoted to the unique regulatory pathways biomanufacturers navigate throughout the product lifecycle, we are now making it easier for companies to address these concerns by providing a series of courses that are geared towards these specific regulatory & compliance requirements.

The courses listed below are truly geared towards a biologics audience, and generally cover the major requirements.

European Filings and Registrations

Live Web Training Course
Tuesday, November 24, 2009
liveondemandfinal
1:20 p.m. -  3:30 p.m. EST
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!

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

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!

How to Survive a DEA Audit

Live Web Training CoursecGMP training
Wednesday, September 22, 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)Pricing
Instructor: Carlos M. Aquino

 

FEATURED IN SEPTEMBER!

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

Fundamental Concepts of Fungal Identification

Live Web Training Course:
Wednesday, October 6, 2010cGMP training
(1:20 p.m. – 3:45 p.m. EDT)
(12:20 p.m. – 2:45 p.m. CDT)
Course Details
(10:20 a.m. – 12:45 p.m. PDT)
Instructor: Ziva Abraham
Pricing

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

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!

A Successful Approach to Writing Effective SOPs

cGMP training2-Part Live Web Training Course
Session 1: Friday, October 22, 2010
Session 2: Friday, October 29, 2010Course Details
(1:20 p.m. – 3:45 p.m. EDT)
(12:20 p.m. – 2:45 p.m. CDT)Pricing
(10:20 a.m. – 12:45 p.m. PDT)

Registration is now open,scheduled based on client request!

A Review of the Principles of Microbial Containment  and Control

Live Web Training CoursecGMP training
Wednesday, October 27, 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)Pricing

Instructor: Frank S. Kohn, PhD