"FDA regulations related compliance training delivered by leading experts through webinars. This section contains compliance training for FDA regulated companies in areas - Audit and Inspection, Validation, 21 CFR Part 11, documentation, submission, Approvals, 510K, GxP , GMP,CGMP, CAPA , Packaging/labeling and Drug Marketing Compliance, Electronic Records, System Based Inspection, Documentation, Software validation."
This Japan Regulatory and Clinical Trial Requirements training will cover Japan Regulatory Agency Structure and Responsibilities, its review process for decision-making and approval, requirements for clinical trials in Japan and the procedures for conducting clinical studies in the country and reporting them.
This 90-minute webinar on Disinfectant Qualification Studies will teach you disinfectant testing methodologies, provide examples of disinfectant efficacy tests and show how to troubleshoot problems related to disinfectant efficacy testing.
Instructor : Jim PolarineLiveFriday, April 6, 2012
This 90-minute cleanroom contamination control training will review the common mistakes that people make in cleanrooms that lead to contamination, show how to develop a successful contamination control program and discuss ways to improve your facility's design and maintenance.
Instructor : Jim PolarineLiveTuesday, March 27, 2012
This 90-minute webinar on Disinfection and Cleanroom Cleaning will cover effective ways to rotate disinfectants, most current industry methods for applying disinfectants and effective methods for controlling residues.
Instructor : Jim PolarineLiveFriday, March 16, 2012
This Software Verification and Validation training will help you understand and recognize the most common software V&V failings and their fixes. You will learn how to develop and use a repeatable software V&V template for all software validation projects.
This 6-hr virtual seminar will focus on the regulatory compliance requirements and procedures for conducting Clinical Trials on Pharmaceutical Products in South Korea. It will also cover topics relating to pre-clinical and clinical requirements and address the structure of the regulatory agencies in South Korea.
The webinar will discuss the do’s and don’ts for using social media in marketing FDA-regulated products. Common issues, misconceptions, perceptions, and possible solutions will be discussed. The presentation will to familiarize you with the current FDA rules and help you plan for developments expected in the near future.
Instructor : Mukesh KumarLiveThursday, February 16, 2012
This 90-minute Verification and Validation Planning training will cover "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.
This Software Validation training webinar will discuss how to approach Strategic software Validation planning so as to satisfy FDA by complying to new enforcement initiative by FDA.
This 90-minute training on Major cGMP Issues for 2012 will show what drug and device companies can do proactively to address failures over cGMP issues and ensure better regulatory compliance.
Jon Groetzinger
is a Visiting Professor of Law at Case Western Reserve University School of Law and teaches courses in International Business Transactions, Business Associations and Doing Business in the U.S. With over 30 years of international business practice experience, he has served as Senior Vice President, General Counsel and Secretary of American Greetings, listed on the New York Stock Exchange.
