Compliance Training Webinars for Regulated Industries

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 medical device reporting webinar will guide you to understand best practices to assess your current MDR efforts and implement changes to match the FDA's new guidance recommendations. Attendees will learn the current regulations that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for any device-related adverse events and certain malfunctions (investigational study 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 how to identify toxic personalities in work and Toxic buffers and protectors who help toxic people get away with bad behavior, how to change recruiting methodology to restrict hiring toxic personalities, what coaching method to use to rectify toxic personalities and make the workplace safe and respectful. Also it will discuss how to calculate the loss due to toxic people in organization so that it is worth come as prime initiative for top management buy in.

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 webinar will teach you how X-Bar and R Charts are used to identify and analyze variation within transactional and manufacturing processes. All Processes in an organizations need to be protected and monitored so monitoring control charts offers Process Owners a way to determine if their processes are in control, capable and stable.

Avoid fires and burns on the job. Learn how to perform hot work safely and keep your workplace injury-free with new Hot Work Safety Certificate Online Training. Learn hot work evaluation requirements, hot work team roles and responsibilities and how to approach for hot work safety.

This webinar will not only address the semantics, but will also discuss the appropriate analytical and statistical approaches to achieving successful verification and validation studies with respect to food microbiology. The quantitative and qualitative methods of performance measurement will be discussed for verification and validation.

In this webinar attendees will learn the guidelines on good storage & distribution practices of pharmaceutical products and the factors affecting the quality of products. Various types of storage conditions & environmental control processes will be discussed to avoid potency loss of drug products while stored in the premises.

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 webinar will discuss the regulations and guidance by EEOC related to termination, how to avoid discrimination or wrongful termination and have termination with dignity and respect. The policies and termination process and documentation steps required.

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.