FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training on legal writing for regulatory submissions will provide practical tips that have proven to enhance the persuasiveness of regulatory submissions and help you succeed even if some of your test results or other supporting information are lacking.

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.

This training on FDA software validation related warning letters will discuss what to do to avoid additional software related compliance issues along with the response steps where the citations that directly or indirectly include automated system.

This training on managing FDA audits will discuss practical tips to be prepared for an FDA audit of your facility, the appropriate conduct during an audit and the follow-up activities to an audit. You will learn the Do’s and Don’ts of an FDA inspection to ensure a successful audit.

This webinar will discuss the scope of the Food and Drug Administration’s (FDA’s) authority to inspect manufacturers of foods, dietary supplements, cosmetics, pharmaceuticals, and medical devices and the Agency’s ability to access company records. It will also cover the potential impact of the draft guidance document on drug inspections that FDA issued in July 2013.

This Comparability Protocols training will provide you with the basics for use as well as provide you with new and expanded ways of using CPs. It will also assist you in finding ways to help shorten the time for implementing pre and post approval changes.

This Spreadsheet validation training explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.

This webinar will discuss the terms GLP and GMP, their definition, similarities and differences and their application in the biologics or pharmaceuticals development environment.

This webinar will discuss the best practices for documentation for FDA regulated companies. You will learn techniques and ideas that will help you identify effective methods to improve your document control systems.

This FDA software validation training will discuss how to approach strategic software validation planning so as to satisfy FDA by complying to new enforcement initiatives by FDA.

This webinar on objectionable microorganisms will show how to identify and prevent objectionable microorganisms that are beyond the ones outlined in USP <1111>. Attendees will learn the clinical implications due to presence of objectionable microorganisms.

This training will provide a solid understanding of FDA Requirements for Device Labeling. Attendees will gain comprehensive knowledge on creation, approval and control of labels and labeling.

This virtual seminar will start by evaluating important areas for regulated companies to focus in 2013-2014, based on the U.S. FDA’s recent "Strategic Priorities" initiative. The second-half of the session will discuss how FDA's global initiatives affect supplier chain management and vendor audits and how you can prepare to address them.

This webinar on handling FDA inspectors will discuss practical tips to cope with a difficult FDA compliance officer or inspector. You will learn how to wiggle out of complicated situations, make legal arguments and challenges to the FDA agent and use meeting requests and other tools to ease tensions.

This 3 hour virtual seminar on China regulatory compliance processes for life science products will discuss the regulatory structure and requirements for compliance against China’s CFDA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

This webinar on preparing for FDA inspections will present simple but powerful tools, with real world examples on how to prepare for an impending FDA inspection. You will learn what essential last minute preparation activities can be done and others that should be avoided.

This webinar on FDA social media regulations will discuss the best practices utilized by medical device, drug and other FDA and FTC regulated industries when using social media channels, i.e., Web 2.0, like Facebook, Twitter, YouTube and LinkedIn to promote products.

This webinar on responding to FDA 483s and Warning Letters will provide tips for avoiding FDA 483s and warning letters, and train you on the best practices in responding to a 483 or warning letter so that you can manage the consequences of the findings from escalating.

This training on FDA cGMPs for Dietary Supplements and Nutraceuticals will discuss current FDA regulations, GMP requirements and techniques to be compliant using easier, shorter and convenient strategies. Case studies of FDA audit experiences will be presented for easy understanding.

This 21 CFR Part 11 compliance training will present a methodology for system assessment, risk-analysis, 21CFR Part 11 compliance, remediation and inventory, along with templates and forms that attendees can modify for their own business.