The submission of a 505(b)(2) applications must be based on the presentation of required scientific evidence of safety and equivalency studies,

Lamont M Fulton

• February 15, 2019
• 60 Minutes
• US$150.00
• Enroll

An analytical method is a process. The FDA process validation guidance applies to test methods.

Jerry Lanese

• February 15, 2019
• 90 Minutes
• US$150.00
• Enroll

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.

Danielle DeLucy

• February 15, 2019
• 90 Minutes
• US$150.00
• Enroll

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Robert J. Russell

• February 15, 2019
• 90 Minutes
• US$150.00
• Enroll

Work remotely is becoming more of a norm in the tech industry.

Audrey Halpern

• February 15, 2019
• 60 Minutes
• US$110.00
• Enroll

Following various incidents, the control mechanisms for medical devices - from heart valves to sticking plasters

Willi Ramseier

• February 18, 2019
• 60 Minutes
• US$110.00
• Enroll

This webinar will discuss various broad and critical aspects of an effective EM program such as the Phases of a cleanroom EM Program.

Joy McElroy

• February 18, 2019
• 90 Minutes
• US$150.00
• Enroll

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.

Roger Cowan

• February 18, 2019
• 60 Minutes
• US$150.00
• Enroll

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program.

Dr. Ludwig Huber

• February 19, 2019
• 75 Minutes
• US$150.00
• Enroll

Most books, articles and courses on managing meetings ignore the fact that leaders, managers

Dr. ArLyne Diamond

• February 19, 2019
• 60 Minutes
• US$110.00
• Enroll

This program will shed light on the true cost of living in a technologically-driven and distracted world.

Mark Gorkin

• February 19, 2019
• 60 Minutes
• US$110.00
• Enroll

This training program will analyze these three seemingly different bodies of law that often overlap leading to ambiguity and confusion.

Janette Levey Frisch

• February 19, 2019
• 2 Hours
• US$150.00
• Enroll

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications

David Nettleton

• February 19, 2019
• 90 Minutes
• US$150.00
• Enroll

The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.

John E Lincoln

• February 20, 2019
• 90 Minutes
• US$150.00
• Enroll

This webinar will lay the groundwork for determining whether your employees are properly classified as Exempt or Non-Exempt and ensuring that wage and hour laws are being followed properly.

Diane L. Dee

• February 20, 2019
• 60 Minutes
• US$110.00
• Enroll