Compliance Training Webinars for Regulated Industries

This training on medical foods will provide an introduction to FDA’s regulation of medical products, assist you in identifying when it may be appropriate to market a product as a medical food; recommend strategies for marketing such products; and summarize recent FDA enforcement actions in the area to help companies mitigate the risk of potential Agency enforcement action.

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 will discuss how to comply with Equal Employment Opportunity Laws, EEOC's investigative tactics and enforcement and what you can do to avoid discrimination charges.

This training will provide the attendees best practices for auditing the Enterprise Risk Management function. Learn the role and importance of audit in maintaining the effectiveness of ERM program.

This training on FDA compliance will provide the attendees with an understanding of FDA expectations regarding end-of-phase 2A meeting guidance. Attendees will learn the best practices to comply with the intent of the guidance and to achieve a higher quality outcome from the meeting.

This training on clinical compliance will focus on the requirements of trial master file (TMF) for pharmaceutical product, biotech, a medical device or a diagnostic product. Attendees will learn the best practices to ensure that the TMF is ready for inspection by the regulatory authority.

This webinar will discuss best practices for premarket notification [510(k)] preparation and submission compliant with FDA's eCopy and Refuse to Accept (RTA) Policy requirements.

This training on food safety compliance will provide the attendees with the knowledge of how food borne pathogens enter a food plant, expand its presence within the facility and contaminate the products. Attendees will learn the best practices for minimizing the presence of these pathogens in the food plant.

This webinar will show how you can devise a clinical trial billing system/ process to manage the billing of clinical trial charges in compliance with Federal rules and regulations.

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 Generic Drug User Fee Amendments of 2012 will discuss the new requirements under GDUFA and effect of GDUFA on the Drug Master File (DMF) process.

This training will provide the attendees tools and techniques for developing and implementing an effective Contractor Management Program.

This training on HIPAA compliance will discuss the modifications made to the Final Omnibus Rule and the impact of these changes on agreements between covered entities and business associates. Attendees will learn best practices for developing and negotiating new business associate agreements.

This trade webinar will cover existing and pending RTAs, the opportunities and challenges they present for your business, the new rules and procedures and how you can comply with them. It will discuss major RTAs involving the US and the EU and opportunities for exporters of goods.

This training on allergen cleaning will cover a rigorous approach to validating cleaning procedures or where cleaning is not possible supporting the need for a ‘may contain’ claim.

This webinar on the use of social media by covered entities will discuss the risks, compliance requirements, the effective policies and procedures that you should have in place when using social media.

This compliance training will provide you simple but powerful tools to effectively manage your legacy contracts. Learn the best practices to implement the processes and controls for contract management at your organization.

This training on FDA regulation of mobile medical applications is designed to provide attendees with an overview of the U.S. Food and Drug Administration's oversight of certain medical and healthcare mobile medical applications ("apps") designed for use on smartphones and other mobile computing devices. Attendees will learn to distinguish between those apps requiring FDA review and those not subject to regulatory oversight.

This HR compliance training will discuss the methods for implementing effective discipline policies and setting performance improvement plans in the workplace. It will also provide tools and best practices for communicating standards of conduct and performance tracking and documentation process.