"Pharmaceutical regulatory Compliance training delivered by leading experts through webinars. This section contains compliance training affecting Pharma industry in areas - Documentation, Software Regulations, Pharmacovigilance & Drug safety, Japan Regulations, Biopharmaceuticals, Cleaning Validation, Computer Systems, Assay Validation, Phase 1 INDs, 510(k) Submissions, National Practitioner Data Bank (NPDB), Healthcare Integrity and Protection Data Bank (HIPDB), Steam Sterilizer Validation, Pharmaceutical Care 101."
This 90-minute webinar will help you understand the problems that can occur with statements by pharmaceutical manufacturers directed to off-label uses of pharmaceuticals.
Instructor : James Lindon LiveThursday, May 24, 2012
This 3-hr virtual session will cover pharmaceutical stability study requirements for Phase I, Phase II, Phase III clinical studies, show how to choose the right stability methods and specifications and review common pitfalls in pharmaceutical stability programs.
This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10.
This course will provide necessary information to those in the drug and device manufacturing industries on how to best work with consumers and health professionals regarding off-label claims of relevant drugs and devices that arise from third parties or from the natural progression of social media.
This 2-hr webinar will review the FDA and FTC regulations for promoting and advertising dietary supplements, walk you through real-life case studies, help you address compliance, and tell you how to respond to an FDA enforcement action.
Instructor : Mark GardnerLiveWednesday, June 13, 2012
This webinar on Risk Evaluation and Mitigation Strategy (REMS) will help you understand how to adhere to REMS policy, its implementation and submission requirements. It will discuss FDA's current thinking on REMS, how it reduces the REMS obligations for sponsors, and how the agency's requirements and procedures in this area are evolving.
Instructor : Orest Hurko LiveThursday, June 14, 2012
This 90 minute webinar will help you comprehensively understand the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application.
This 6-hr training will focus on important microbial issues with pharmaceutical water systems and provide proven solutions for microbial control. Attendees will learn effective sanitation and validation approaches to successfully control biofilm in water systems.
This webinar will provide an introduction to FDA’s regulation of veterinary regenerative medicine and highlight the regulatory requirements that a biotech company needs to satisfy to commercialize a stem cell or other complex biotech product for animal use in the U.S.
Tony Gutierrez is Vice President of Integrated Benefit Solutions, Inc./White Bear Group Consulting. He has expertise is group life, health and voluntary benefits. Tony is currently a member of and webmaster for the Triangle Association of Health Underwriters. He is also technology chair for the North Carolina Association of Health Underwriters. Tony has served as media relations chair for the Triangle chapter, NC state chapter, and National Association of Health Underwriters. He has been to Washington on several occasions representing health insurance agents and brokers to discuss Health Reform legislation. He is an experienced course designer, developer, and instructor. Tony has a bachelor degree in Electrical Engineering from NC State.
