Medical Devices & Combinations

While the overall medical device industry is thriving, advances in technology are blurring the lines between traditional pharmaceuticals, biologics and medical devices. Further advances in technology have resulted in a steady increase in the number and types of combination products that are being marketed and moving through R&D pipelines. This poses a major challenge, both for the companies who are manufacturing and developing these products, and for the regulatory agencies that provide the framework and guidance required to keep international consumers safe.

BenAstrum is committed to providing comprehensive and up-to-date content to address the needs of both traditional medical device manufacturers and those companies working on combination products. The courses listed below are designed to address the unique requirements and regulations pertaining to medical devices:

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 – 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

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!

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

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!