"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 combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
This 6 hour virtual seminar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.
This 2-hr Dissolution Instrument Qualification webinar will discuss recent FDA requirements for dissolution instrument qualification and provide practical suggestions to avoid pitfalls in performance of the tests, minimize Performance Verification Test and product failures.
Instructor : Gregory MartinLiveTuesday, February 28, 2012
In this sterility assurance documentation webinar, you will learn specifically what information is required in sterility assurance documentation for injectable drug products and how to present it in CTD format. You will understand differences in content for terminal sterilization versus aseptic processes.
Instructor : Colin DavisLiveThursday, February 23, 2012
This US FDA draft guidance documentation webinar/ training will give an insider’s insight into the new guidance and regulation and discuss the rationale for such.
This webinar on addressing fungal and bacterial spore outbreaks will discuss case studies on excursion investigations and show how facility design, personnel practices and cleaning and disinfection effect excursion investigations.
Instructor : Jim PolarineLiveMonday, February 13, 2012
This 90 minute interactive webinar will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations.
In this Water System Webinar the author will explain the process he uses as a consultant for investigating and solving water system or product contamination problems with water organisms. Case studies of real life problems he has resolved will be presented to illustrate the process. Though there is no rule book or SOP for such contamination problem solving, learn the best practices of solving these problems from an expert.
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.
