Compliance Training Webinars for Regulated Industries

This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.

This webinar will review the OSHA PIT Standard with a focus on training and qualifications of Trainers, and the components of an effective Training Program. This process is not as simple as one would think.

This webinar will discuss Vicarious Liability and its implication, how managers can be implicated during disciplinary action due to their behaviors, how employers can train managers to mitigate risk during disciplinary actions and terminations. What part of affirmative defence can help reducing allegations of discriminations.

This webinar will help understand data analysis requirements for QSR, the techniques to identify problems, analyze cause and action plan preparation to avoid FDA inspection and MDSAP audits. It will help you understand how to pick right data analysis techniques from ISO/TR 10017:2003 and how to analyze data in excel.

This webinar training analyzes critical components of a Cyber Incident Response Plan and provides recommendations on how to prepare all staff for the inevitable situations. From internal considerations to your external solution providers, get a realistic view of how a cyber-attack can quickly spiral a typical day into complete chaos and cause significant losses without preparation. Attendees will receive a Cyber Incident Response Plan checklist to help their Incident Response Team analyze or develop a Plan.

This webinar will discuss the history of biosimilar - how EMA led the way and how FDA is catching up. It will give Insight into the varying regulatory approaches prevailing in different regions & overview of the Biosimilars picture across the world, the barriers (known as "The Patent Dance") to entry. It will discuss about interchangeability issues, what proof does FDA require, US biosimilar registrations success and failures and how to avoid failures. Enough background to determine whether entering the biosimilars market is an appropriate strategy for their company.

This OSHA recordkeeping webinar will discuss the more subtle nuances of recordkeeping, with review of pertinent OSHA Q&As and hypothetical scenarios. The OSHA 300 Log, the conflicting doctor rule, restricted work and significant aggravation.

This training program will address why internal controls over travel and entertainment (T&E) expenditures are a critical component of the control environment. Although the topic of travel and entertainment abuse is not one that management likes to address, it is a very important indicator of the adequacy of a company’s control environment.

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 explains how the ISO 13485 (Medical Devices) & ICH Q10 (Pharmaceuticals) quality manuals create a systematic, formal and collaborative approach for establishing roles, authorities and responsibilities in the planning, development, and implementation of inter-functional cGMP procedures (i.e. Incoming Material Control, Change Control, & Design Control), required by FDA regulations. Particularly applicable are 21 CFR Parts 210-211, Parts 803, 810 & 820, & ICH Q7A. The Quality Manual (QM) synchronizes the law and regulations with quality principles, industry practice, and the writings of “quality gurus”. The organization of the QM’s Table of Contents predicts how well the company understands and practices quality concepts.

This webinar will discuss causes of subcontractor delay and impact claims. Attendees will be exposed to contractual issues surrounding subcontractor delay claims and learn the theories of recovery a subcontractor can employ when pursuing a delay claim against the General Contractor. The program will identify practical problems concerning subcontractor delay claims from the project owner’s viewpoint and discusses what damages may flow from subcontractor delay claims and the recoverability of such damages.

This webinar will discuss differences between Pregnancy Discrimination Act (PDA) and the Family and Medical Leave Act (FMLA), disability and maternity leave, what benefits apply to new parents, what documentation required for pregnancy related absences, how to discipline a pregnant employee to avoid any kind of pregnancy discrimination complaints.

This 3-Hr webinar on “Validation and Verification of Analytical Methods” by Dr. Huber will discuss the recent changes in guidance from regulatory agencies (FDA/EMA, USP and ICH) on method validation and transfer, integrated validation, verification and validation of analytical procedures for equivalency testing and statistical evaluation. He will teach how to execute document development, how to demonstrate FDA and EU compliance to auditors and inspectors, how to explain company’s strategy for method validation, verification, transfer and equivalency testing etc.

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 discover the top trends ASC facilities are facing with contracting with Medicare and third party payers. You will get the tips and tricks to ensure your negotiations are successful. You will learn to weigh the pros and cons of contracting to decide if out-of-network billing may be the best route for your business.

This risk assessment webinar will discuss how to do perform risk assessments for ERM, IT and Internal control function of your organization. Attendees will learn how to create/develop risk assessments, how to complete the ERM Risk Assessment using the ERM Risk Assessment Matrix. And how to complete the general IT Risk Assessment as well as a thorough Risk Assessment for your Internal Controls.

This webinar will highlight the changing circumstances with respect to software regulations and FDA’s approach from a regulation to voluntary standard. How to understand the qualifications and terms of participation to clear its software for marketing, what to do in case of cybersecurity intrusion and how to update regulatory program as mobile apps are removed from FDA’s regulatory oversight.

This webinar will discuss the new GDPR regulation requirements in the context of clinical trial data, how it applies to clinical trials and pharma industry, the personal data types including clinical trial data, what are the rights of clinical trials subjects, data access requests, informed consent, how to transfer clinical trial data outside EU, data breach reporting, penalties and how to put a data governance program and process to comply with GDPR regulations.

This webinar will discuss how to accurately assess the impact of Brexit up on your operations and existing licensed life products in the UK and EU. How to plan to becoming compliant on “what is known” and how to be agile as the rest of implications become clearer. Impact on Filing Registrations with EMA in Q1 2019, How Will the UK’s Withdrawal Effect the Sunset Clause.

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.