FDA Compliance

The US Food & Drug Administration, commonly known as the FDA, is an Agency within the US Department of Human & Health Services and arguably the single most influential Life Science Regulatory body in the world. Their main responsibilities include regulating and supervising the safety of foods, tobacco products, dietary supplements, Medication drugs, vaccines, Biopharmaceutical, medical devices, veterinary products, cosmetics, in addition to a host of other products.The FDA is a participating party within the ICH and also constitutes the US government’s oldest consumer protection agency.

A large number of BenAstrum courses deal directly with FDA guidance, regulations and procedures. A list of upcoming sessions includes:

FDA Compliance

The US Food & Drug Administration, commonly known as the FDA, is an Agency within the US Department of Human & Health Services and arguably the single most influential Life Science Regulatory body in the world. Their main responsibilities include regulating and supervising the safety of foods, tobacco products, dietary supplements, Medication drugs, vaccines, Biopharmaceutical, medical devices, veterinary products, cosmetics, in addition to a host of other products.The FDA is a participating party within the ICH and also constitutes the US government’s oldest consumer protection agency.

A large number of BenAstrum courses deal directly with FDA guidance, regulations and procedures. A list of upcoming sessions includes:

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!

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!

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

Disinfectant Choice, Qualification and Cleanroom Contamination Control | Disinfectant Qualification Study – Planning, Execution, and Review

2-Session Live Web Training Course:
Last Conducted on:liveondemandfinal
Session 1: Tuesday, September 7, 2010
Session 2:
Tuesday, September 14, 2010

Instructor: Ziva Abraham

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

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

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

Drug Master Files (DMFs) - Understanding & Meeting Your Global Regulatory and Processing Responsibilities

Live Web Training Course
liveondemandfinalLast conducted on:
Tuesday, February 16, 2010
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

Preparing for FDA GLP Audits

Live Web Training Courseliveondemandfinal
Instructor: Dr. Nanda Subbarao
Last conducted on:
Wednesday, May 26, 2010

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!