Compliance Training Webinars for Regulated Industries

This training program will analyze Title 19 CFR 171 - U.S Customs Prior Disclosure. It will objectively evaluate customs errors and mistakes and define the pros and cons of disclosing to customs. The program will further demonstrate the consequences of disclosure or non-disclosure and remedial measures.

This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.

This training program will closely examine what are extractables and leachables. It will focus on how to design and implement leachable stability programs, including the requirements for leachable stability programs, developing and validating methods for use in leachable stability programs, and drug product impurities vs. leachable impurities.

This webinar will discuss in detail the fundamentals of data integrity including the FDA guidance document. It will teach attendees practical steps to identify and avoid data integrity issues in pharmaceutical laboratory.

This training program will break down the essential elements covered under OSHA 29 CFR 1910 and 29 CFR 1926 with respect to construction, engineering and scientific cost estimating. In particular, the webinar will discuss techniques for preparing rough estimates, techniques for evaluating and estimating scientific processes, contingencies, overhead and profit, estimating cost of new construction, estimating costs of environmental remediation, and more.

This training program will offer insight into where extractables and leachables come from. Attendees will learn the regulatory expectations and trends for extractables and leachables in early phase development and learn which products may require E&L data in early phases. The program will also focus on how to design programs to meet the needs of early phase development – i.e. phase appropriate E&L programs.

This webinar provides understanding of the requirements for residual solvents addressed in ICH, USP, EP and JP and focus on the recent changes to USP <467>. It will also help attendees utilize strategies to minimize the testing and resources required to meet the requirements.

This webinar will review the best practices associated with use of ladders of all types, including the selection, inspection, storage and transport of ladders, along with safe practice when erecting, climbing, working from and descending a ladder. It will also discuss the process and practices related with aerial lifts and working from buckets on an extended boom.

This webinar will assist employers with effective strategies to identify, investigate, and terminate FMLA abusers. Additionally, the course will also instruct employers on when it is appropriate to deny FMLA requests in accordance with the law.

This webinar will explain the final version of USP Chapter <1224> and FDA guidance for conducting and documenting method transfer between laboratories and sites, and provide tools for effective implementation.

This webinar will explore the common failures associated with organizing and writing Job Hazard Analysis / Activity Hazard Analysis (JHA – AHA) documents. It will also de-mystify some of the language and concepts in the traditional JHA process, namely the risk assessment calculator.

This webinar will explain how to calculate the correct valuation on a product while importing from related party suppliers. Instructor will discuss how to document transactions for CBP process and to recognize valuation issues that may cause price adjustments after import. Participants will learn to avoid adverse consequences of declared valuation errors and what are the downsides to participation in reconciliation.

This training program will detail the requirements for ICH stability studies, discuss how to design stability programs for your drug product, and list analytical methods requirements. It will also focus on how to interpret the data generated by the stability programs.

This webinar will describe the elements and characteristics necessary for the development and writing of an occupational health and safety Plan. The main component of this Plan will be your ‘Company Safety Manual” however the actual Plan will encompass far more than a Manual.

This training program will go into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.

This FMLA and ADA training program will discuss why it is crucial for employers to have at least a basic knowledge of the laws to apply them correctly and avoid litigation. Both the FMLA and ADA are confusing laws on their own. When there is an overlap between the laws, it can be even more confusing, frustrating, and almost impossible to manipulate. The key to untangling ADA and FMLA is to understand the obligations under each statute.

This training program will concentrate on the requirements to classify a worker as an independent contractor or as an employee under the IRS rules. The course will further illustrate how the FLSA rules differ from the IRS rules and why you must follow both.

Medical Device Tracking is a very important aspect of the distribution chain of a medical device. This is because it is critical to have a mechanism by which a medical device can be traced and located in its place after it leaves the manufacturer. This system of tracking helps to identify a defective device and ensure that corrective measures are taken immediately.

Learn what constitutes a meal or rest break and your obligations as an Employer under California's employee break laws. Understand the requirements and the possible violations and penalties associated with CA meal and rest break compliance

In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 changes. He will also discuss best practices for negotiating and drafting physician practice acquisition arrangements on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided.