Compliance Training Webinars for Regulated Industries

This training on ISO 14971:2007 will help you understand the risk management process for medical devices, including risk analysis, risk evaluation, risk control and post-production information.

This webinar highlights the evolution of Enterprise Risk Management (ERM), the importance of ERM in meeting board fiduciary responsibilities, and the rationale and mechanisms for ensuring effective risk management through the board.

This Clinical trial auditing training will provide valuable assistance how to conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. How to assure your clinical trials are in compliance and meet the agencies requirements.

This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.

ISO 31000 is a standard developed by the International Organization for Standardization (ISO) which provides a basic guideline and principles for the application of risk management. Companies that use risk management processes vary across industries in scope and magnitude and address a wide variety of challenges. This training program will offer an in depth look into the key components of the ISO 31000 guideline and best practices to implement and support a corporate risk management strategy or program.

Corporations are facing more risks in the expanded environment of business. This webinar will provide auditors and audit management with advanced approaches to risk management and internal risk assessment at a corporate level.

This Risk management training module will describe a common set of criteria for disaster/emergency management and business continuity programs.

This Product risk management training/webinar for Medical devices will help in to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007. The US FDA is increasingly stating that many regulated activities should be “risk-based”. Major resource-consuming activities such as product and process / equipment / facility, and software validation, CAPA investigations, vendor audits can all be tailored to a risk based approach. This eliminates the current SOP-defined “one size fits all” approach, to a flexible, resource adjusted approach, less arbitrarily defined in an SOP, but yielding results targeted to real needs. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry. Then how to use this document to accomplish the above goals.

This Enterprise Risk Management training (ERM) will provide a framework for evaluating the effectiveness of risk management based on an inventory of questions an effective ERM program should be able to answer.

This FDA compliance training will be valuable who are involved in the development of REMS and who are planning a submission and need to understand what might be required by FDA and how to comply and for those who have Risk Management Plans.

This Cleaning validation training will provide valuable assistance to all regulated companies that need to develop and validate their equipment cleaning processes. This session will address risk-based approaches to cleaning validation studies using ICH Q9 and recent FDA comments and observations as a foundation. Recent FDA warning letters illustrate just how critical good cleaning practices are. Understanding and employing good cleaning practices are instrumental to improving cleaning consistency, quality and traceability. The FDA favors automated CIP systems since they reduce operator variability while enhancing consistency and reproducibility. Our research has indicated that in the last 5 years, cleaning citations were noted in 50% of warning FDA letters. Many cited contamination issues have an element of poor cleaning practices associated with them. Examples include “investigations…did not include an evaluation of the cleaning processes and procedures…to determine if equipment cleaning is effective in preventing cross contamination of the inactivated batches”, FDA Warning Letter, Jan 2008; "vaccine manufacturing plant in Pennsylvania, has been served with an FDA warning letter asking for measures to ensure batches of its flu shot ingredients do not become contaminated again.” Jul-2006..

An overview of ICH risk management techniques and how to apply them to equipment cleaning programs will be discussed. In addition, case studies from manufacturing facilities will be used to illustrate risk-based cleaning validation principles and practices.

This 510(k) Training covers the content requirements of a traditional 510(k) application and covers in detail the recommended 20 sections. This 510(k) Training deals only with those medical devices that require a 510(k) application. All Manufacturers introducing Class II medical devices to the US market must submit a FDA 510(k). It is also required for manufacturers that are changing the intended use of the medical device, or changing the technology of a cleared device such a way that it may significantly affect its safety or effectiveness.

This Risk Management training will cover Risk management & Risk assessment within all business processes. Risk management is a concern that must be taken seriously in all aspects of your business. Are you prepared for the problems you may face?

Learn how to comply Sarbanes Oxley compliance in a cost-efficient manner. Many have questioned whether the Sarbanes-Oxley law requirements can be met in a cost-efficient manner. Absorbing the first-year lessons — and, going forward, is a challenge facing all public companies as they prepare to meet quarterly and annual reporting requirements. And further challenges will arise as new compliance issues emerge and PCAOB regulations evolve.

The training supports SOX Compliance (particularly Section 30 as it pertains to anonymous hotlines), and conforms to key criteria of the revised US Federal Sentencing Guidelines. Know how to promptly and effectively REPORT incidents of fraud or suspicious conduct.

This presentation explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.

While simple to describe many companies fall into the trap of territoriality, and confusion of roles and responsibilities. This webinar will walk through the elements of a process validation program for biological products with an emphasis on the involvement of all functions especially process development.

This webinar discusses the use of risk analysis techniques applied to medical device software including discussions of pitfalls in the process of risk analysis. This webinar will provide guidance to medical device companies that need to perform risk analysis on their software products and internal systems.

This risk-based software V&V training will guide you through 11 "must have" elements of software validation and how to use your Risk Management Tools (per ISO 14971:2007).

The keystone of AML compliance is the reporting to proper authorities of those transactions and activities considered to be suspicious