Compliance Training Webinars for Regulated Industries

This 6-hr training will focus on important microbial issues with pharmaceutical water systems and provide proven solutions for microbial control. Attendees will learn effective sanitation and validation approaches to successfully control biofilm in water systems.

This webinar will provide an introduction to FDA’s regulation of veterinary regenerative medicine and highlight the regulatory requirements that a biotech company needs to satisfy to commercialize a stem cell or other complex biotech product for animal use in the U.S.

This webinar on Trial Master File (TMF) for clinical research sites will show how you can create an FDA compliant TMF to ensure that it will pass inspection by FDA investigators and QA Auditors.

This 90-minute webinar will discuss the current good manufacturing practices (cGMPs) for medical devices and in vitro diagnostic devices.

This 90-minute webinar on sampling plans using ANSI/ASQ Z1.9 will explain the methods in Z1.9 and shows how to use it in a more modern setting (using simple statistical calculators).

This webinar presents a best practices approach for preparing, characterizing and storing cell banks used for GXP analytical and bioanalytical test methods. It covers critical topics such as timelines for generation of cell banks, equipment, growth conditions, purity, consistency, and stability.

This webinar on issue detection and escalation in clinical trial settings will review the responsibilities of sponsors, investigators, IRB, vendors and CROs in clinical trial setting to maintain compliance. We will discuss how you can proactively monitor to prevent issues and in case of issue detection, escalate them.

This 90-minute presentation will discuss a structured way to mitigate risks with minimum cost. You will learn how to use FMEA to effectively estimate and assess risks in your medical device.

This 90-minute webinar will discuss the new FDA "Global Engagement" Initiative for new areas for heightened CGMP compliance from U. S. FDA-regulated companies and their global partners. It will cover areas for increased awareness, focus, and remediation, and the approaches that are now mandated.

This webinar on Risk Evaluation and Mitigation Strategy (REMS) will help you understand how to adhere to REMS policy, its implementation and submission requirements. It will discuss FDA's current thinking on REMS, how it reduces the REMS obligations for sponsors, and how the agency's requirements and procedures in this area are evolving.

This 90-minute webinar will help you understand the Americans with Disability Amendments Act (ADAA) requirements, concepts, and broad applicability of the Act. It will answer critical questions address common problems that employers face in implementing the ADAA.

This 90 minute interactive webinar will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations.

This training on harassment investigations in the workplace will cover practical steps to conduct effective and legally compliant investigations into harassment, discrimination, or other misconduct allegations/ complaints.

This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software.

This course will provide necessary information to those in the drug and device manufacturing industries on how to best work with consumers and health professionals regarding off-label claims of relevant drugs and devices that arise from third parties or from the natural progression of social media.

This 90-minute webinar on device corrections and removals will clarify your obligations for corrections and removals under Part 806 of the FDA regulations.

This training will provide a practical methodology for creating and applying Risk-Based Equipment Validation. It will show an example of how this process may be integrated into a facility Master Validation Plan.

This webinar on clinical trial audit/ inspection preparedness will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how you can ensure that the conduct of clinical research at the investigative site(s) complies with them.

This 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records.

This 90-minute webinar on HIPAA Breach Notification will show how to create an effective breach notification policy for your organization and how to follow through when a breach occurs. You will learn about the kinds of threats that exist for PHI, information security methods you can use to keep breaches from happening, and be in compliance with the HIPAA Security Rule as well.