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Why is FDA at my facility, and what do I do during an inspection?: 2-day In-person Seminar (by Compliance Online)
Summary: This two day course will prepare firms for a quick, productive, and efficient FDA inspection. Included are segments on FDA Law, how to prepare for the inspection, how to prepare your subject matter experts (SME’s) to respond properly, and how to respond to an FDA 483 or Warning Letter. Case Studies and Templates are included.
Understanding FDA and Avoiding Inspections Leading to Warning Letters, Seizures, Injunctions and Prosecutions: One and a Half-day In-person Seminar (by Compliance Online)
Summary: You will learn what are the observations and events that will signal to you that serious regulatory actions may follow
The Importance of a Risk Based Approach in Implementing and Maintaining an Enterprise Wide Compliance Program: 2-day In-person Seminar (by Compliance Online)
Summary: This seminar will provide an overview of the importance of the risk based approach in implementing and maintaining an enterprise wide compliance program.
The European Clinical Trial Directive…Plus…European Filings and Registration Procedures: 2-day In-person Seminar (by Compliance Online)
Summary: This interactive two day seminar will cover the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States, as well as fully across all Member States of the European Union.
Statistical Considerations for ICH Guidelines: 2-day In-person Seminar (by Compliance Online)
Summary: This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm.
Statistical Analysis for Product Development: 2-day In-person Seminar (by Compliance Online)
Summary: This highly interactive course will allow participants the opportunity to develop strategies for analysis of experimental data. The objective is to provide participants with key technical information along with perspectives to enable them to apply the technologies to their own projects and evolve their own statistical methods to support the various stages of product development.
SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations: 2-day In-person Seminar (by Compliance Online)
Summary: This workshop contains a collection of practical tips from the instructor’s extensive FDA audit experience. Common questions regarding validation requirements, handling deviations, frequency of review and update, evaluating non-SOP driven processes, global SOPs, and ways to address FDA 483s regarding SOPs will be discussed using sample SOPs.
Roadmap of California Medical Leaves - Ultimate Guide to PDL, FMLA, FEHA, SDI, CFRA, PFL, ADA and Workers Compensation and Handling Performance Management Challenges: One and a Half Day In-Person Seminar (by Compliance Online)
Summary: This comprehensive interactive training workshop will help clarify California specific leaves, how they interact with the Federal medical leaves and how to apply leaves accurately and consistently.