Compliance Training Webinars for Regulated Industries

This webinar will provide practical information on the FDA requirements for complaints, but expands the traditional scope to include closely linked, but often overlooked processes. It will explore the problems that can trigger FDA reports such as Medical Device Reports (MDRs), Corrections Reports, and Removals Reports. On the servicing side, the course will detail the requirements to analyze service reports, show how they can trigger MDRs, and automatically become complaints. This webinar will minimize the use of regulatory language and easily illustrate how participants can implement an effective and unified system. As an added bonus, the webinar will include information on the UDI rule and the eMDR rule.

Through this course, attendees will learn what works and what doesn’t when trying to get the attention of a new prospect. And how to close more deals – sooner. If you’ve ever wondered why some sales and marketing approaches work better than others, then this webinar will illustrate why. Attendees will learn the dos and don’ts of good marketing and sales practices and how to stand out from competitors.

As compliance with the Foreign Corrupt Practices Act (FCPA) and other anti-corruption statutes has matured into its own field, compliance professionals are faced with the proverbial one-way ratchet. U.S. enforcers’ compliance expectations continue to increase, and compliance programs now need to address multiple laws as more countries enhance and enforce their own anti-corruption regimes. This course will address the essential elements of an effective compliance program.

This FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls.

This 90-minute webinar will provide an overview of regulatory management for clinical trials. It will discuss key regulatory aspects of a clinical project such as clinical protocol management, IRB management, safety reporting, rules for recruitment programs, seeking advice from FDA, trial master files, and training requirements.

This webinar will introduce attendees to the basics concepts and techniques of blinding of investigational drug products. It will also provide an understanding of the complexities of the work required to prepare blinded products for clinical trials.

Between federal and state laws, with so many changes and additions to disability leave, employers must be familiar with the latest updates to the disability laws. This webinar will offer insights into these updates on disability leave including ADA, FMLA, PPACA and HIPAA.

This webinar will help attendees comprehend how exempt and non-exempt workers are classified. It will offer key guidance for HR professionals to identify exempt versus non-exempt employees as given by the Fair Labor Standards Act.

This webinar will provide attendees insights on analyzing financial statements and reports for fraud. Attendees will learn to look at a financial statement with a knowledgeable outlook to understand its author’s motives.

This webinar will provide attendees an overview of the relevant statutes, including the Competition Act, Food and Drugs Act and relevant regulations and information about the existence and operation of Canadian advertising pre-clearance agencies. The rules around advertising and marketing health products will be explained using examples, and hot topics in advertising and marketing will be covered, including the use of social media, testimonials and endorsements.

Regulators, executives, and boards have raised the bar for operational risk programs. There has been frustration from all key stakeholders with the perceived lack of value. It’s critical that there is a realistic expectation and picture of a truly mature program. It is in everyone’s interest to agree upon a true maturity level that is sustainable, attracts talent and is attainable in line with business direction.

More than fifteen states have passed medical marijuana laws, and more are on the way. Even if your state does not have current marijuana legislation, a clear understanding of the present status of marijuana and medical marijuana under the federal and state laws is essential. This course will offer participants a broad overview of the proposed regulatory model for medical marijuana laws and drug testing policies, using case laws to illustrate the same.

The new omnibus update to the HIPAA regulations now in effect contains numerous changes based, for the most part, on The HITECH Act passed in 2009. Some of the most significant changes for medical offices have to do with changes to individual rights under HIPAA that require changes in policies and procedures and must be properly noted in your forms and notices. All HIPAA privacy policies and notices of privacy practices (NPP) must be updated to meet the new rules. This course will describe the schedule of implementation and scope of the changes.

Audit committees are a fundamental part of the proper governance of any organization, together with the executive management and internal as well as external audit. This webinar will explore the role of the audit committee in corporate governance and risk management.

This webinar will summarize the regulatory requirements for FDA’s proposed new regulation – “Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventative Controls for Human Food” - 21CFR Part 117. The GMP component of this regulation (Subpart B) is intended to replace the current outdated GMP regulation (21CFR Part 110) when it becomes effective, as expected, in 2015.

Selecting the best applicant who is the right match for your organization is vital to your organization’s success. This session will review effective interviewing strategies that can apply to all positions, including legal dos and don’ts for interviewing that expand beyond the human resources office.

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.

One of the first HR tools a company will install is an employee policy manual. It is important to have a manual and keep it current and reflective of the company, its mission and philosophy. This course will guide attendees in writing policies for different segments of the company, understanding the most common problem areas, and assuring consistent application of the policy.

This training will address the import record-keeping and audit compliance procedures that will emphasize the importer obligation to maintain and assess internal and external records that are related to their international trade transactions.

This course will aid participants in minimizing errors in pharmaceutical and chemical classification under the Harmonized Tariff Schedule (HTS). It will help better protect your company during import/export audits from the government. Participants will also learn how to take reasonable care as an importer and become aware of best practices and red flags in the area of classification for imports into the United States.