Compliance Training Webinars for Regulated Industries

This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use.

This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.

This webinar will review not only the Anti-Kickback Statute and its safe harbors, but will provide an in-depth overview of OIG guidance and advisory opinions dealing with marketing activities, as well as a review of case law regarding marketing behavior.

This webinar on Cal/OSHA Enforcement and Defenses will cover the recent changes in the law, specifically the four most significant developments in Cal/OSHA enforcement and defense that will have an impact in 2015.

A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.

This program is going to cover the proposed changes that CMS wants to make for all hospitals including critical access hospitals. These changes will affect many different departments of the hospital including nursing, QAPI, medical records, lab, restraint standards, discrimination, patient rights, and more.

This webinar will break down the Board’s role in effective cybersecurity oversight, the 12 questions a board member should be knowing to answer, key principles of oversight, tips and resources for board.

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.