"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 FDA warning letter Webinar/training will discuss what to do to avoid additional software related compliance along with the response steps where the citations that directly or indirectly include automated system.
This webinar on validating legacy computer systems will give a good understanding of FDA and EU regulatory requirements for validation (retrospective validation) and provide tools for effective implementation.
This training will provide a practical methodology for creating and applying Risk-Based Equipment Validation. It will show an example of how this process may be integrated into a facility Master Validation Plan.
This webinar will cover techniques and process that can help you assure reliability and consistent quality from your suppliers or contract manufacturers. You will learn how to monitor your supplier and ensure they meet FDA's quality requirements.
This FDA warning letter closeout program will discuss how to successfully complete warning letter close out program which will help firm to obtain a closeout letter from FDA.
Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable.
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 GAMP® 5 training/Webinar will discuss on the GAMP® software validation model and the defined process of GAMP® 5 as it applied to FDA 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 will provide you a thorough understanding of the updated framework surrounding Good Pharamcovigilance Practices (GVP) in the EU. This will include updates to the EU regulation, Directive and the first seven PV Modules, which have been published for consultation.
Alan Calder
Alan Calder is an international authority on IT governance and information security management. He is the author of IT Governance: Guidelines for Directors, and IT Governance Today: a Practitioner's Handbook. He is the founder director of IT Governance Ltd (www.itgovernance.co.uk), and has consulted with a wide range of companies (including Cisco) on how to deploy best-practice frameworks to improve regulatory compliance and reduce compliance-related cost and risk profiles.
