Compliance Training Webinars for Regulated Industries

Get a detailed understanding of how to perform risk assessment as part of the 10-step risk based approach to CSV.

This V & V planning Webinar/ training will discuss how to companies can re-evaluate their V & V system and related documentation to get to a compliant and new systems and procedures.

Recent changes impact not only the employment of foreign nationals, but the broader workforce comprised of green card holders and international travelers. Executive leadership is looking to compliance officers, legal departments and human resources to understand how these changes affect their company. Tune in to learn how to ensure your business is not adversely affected by changes in immigration legislation and policy.

This comprehensive training package of five courses covers the control of foreign material and pathogens in food manufacturing as well as food recall handling techniques/management.

ISO 27001, ISO 27002, NIST SP800-53 rev.4 Information System Management System (ISMS) are systematic approaches to managing sensitive company information so that it remains secure. It includes people, processes and IT systems by applying a risk management process. In this webinar, You will receive valuable information that you can implement. This is a must in the new world that is facing new Information/Cyber risks every year.

Developing an efficient Incident Response Program that allows an organization to respond with speed and agility is crucial to empowering businesses to maintain continuous operations. Such a solution also reduces revenue loss, reduces fines and lawsuits and protects brand reputation. Information Security, Governance & Risk, are all critical aspects of planning and execution of the Information Security Plan.

This comprehensive training package of three courses is aimed at helping clinical laboratories ensure compliance with CLIA requirements.

This comprehensive training package of six courses provides enterprises a clear understanding of workplace safety issues such as accident investigation, lockout/tagout, OSHA inspections, OSHA injury and illness recordkeeping, effective safety programs and hazard recognitions techniques.

This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.

This webinar will highlight and summarize the main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.

Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when auditing EM programs.

This webinar training will discuss how to create, test and implement an effective cyber Incident program to counter cyber threat and malware attacks. The Instructor will explain how to measure an organisation’s susceptibility to a cyber attack and will outline critical action areas in such event.

This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.

In this Risk Management webinar attendees will learn the resilience strategies, recovery objectives, cyber/information security, business continuity and crisis management plans and including obtaining management support and organizing and managing the formulation of the function or process either in collaboration with, or as a key component of, an integrated risk management initiative.

This webinar is designed for managers and project leaders who have been tasked with implementing a computer security incident response team (CSIRT). Attendees will learn how to develop a CSIRT Policies, Program, Plan, Playbook, Training and Exercises in their organization.

This training program will discuss how to develop a great GRC program that ensures proper governance, risk management and compliance management of all IT systems and processes that support the business operations.

In this presentation attendees will understand the FDA regulations (21 CFR Subpart I) regarding NCMR, how NCMR should be integrated into your CAPA system, how to best approach NCMR (including initiation, segregation, evaluation, investigation, notification, and disposition), examples of documentation you can use to fulfill the NCMR requirement, as well as tips and tricks to what FDA auditors will look for when they come to visit your site. It will also highlight additional tips and tricks on how to convey the importance of NCMR within your organization and ensure resources are provided to meet process needs.

This webinar will discuss the evolving regulatory requirments for testing Biologics injectibles for sub-visible Particulates.

Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study.

This training will cover the best practices for implementing and auditing a Business Continuity Plan. The speaker will discuss the lifecycle of a BCP program with specific emphasis on Risk Assessment and Business Impact Analysis, Designing a living BCP & Testing & Maintenance. The program will also detail the various standards from FFIEC to ISO. Participants will understand what’s involved in a full BCP program and have insights based upon field experience that can be applied to Internal Audit work and BCP. The session will provide you with tools that you can bring back to your company to improve upon BCP programs & ability to audit them to provide targeted recommendations.