Compliance Training Webinars for Regulated Industries

As one among the most leading causes for warning letters and consent decrees, software validation and its compliance are essential to keep your business ready for FDA audits and inspections. Learn best practices to conform to FDA software validation requirements in this webinar with a leading FDA and regulatory affairs expert.

This webinar highlights the importance of an effective ERM program in project management and risk assessment. Attendees will learn how to implement a viable ERM program including documenting and testing it.

This webinar will discuss in detail key auditing elements of an Active Pharmaceutical Ingredient (API) facility/operation. It will cover selection, designation and documentation of starting materials; qualification of analytical methods; control requirements for multi-product/multi-processing API production facility; QA review and release of API and much more.

This webinar will explain what FDA expects in incorporating risk in the CAPA process, what strategies can be used to assign resources to CAPA activities, and how to manage multi-level CAPA processes so that they will not run afoul of the FDA during inspections

This webinar will discuss the FDA guidelines for handling unsolicited requests about off-label information. It will provide attendees a list of dos and don’ts related to social media techniques in off-label promotion.

This webinar will discuss regulatory requirements for adverse event reporting for dietary supplements and OTC products. It will explain the similarities and differences in reporting adverse events for dietary supplements and OTC products and will also discuss trends in FDA audit for these products.

This webinar will highlight the key elements of the Chemistry, Manufacturing and Controls (CMC) section of an IND and NDA application for a 505(b)(2) product using examples and case studies. It will also discuss role of Drug Master Files (DMFs), and cross reference authorizations.

This Comparability Protocols training will provide you with the basics for use as well as provide you with new and expanded ways of using CPs. It will also assist you in finding ways to help shorten the time for implementing pre and post approval changes.

In this Quality management training you will learn how to develop thorough maintenance documents that are clear and confusion-free and you will discover how to perform and document corrective work in a manner that eliminates ambiguity.

This Internal Quality Audit training is presented as a practical way for an organization to evaluate its internal audit program and make required improvements.

Below Training CDs are top identified trainings on financial frauds, most important rules and regulations and how to stay compliant. Along with techniques to identify and how to deal with various frauds like Accounts Payable and Employee Reimbursement Fraud, you will also learn all about Standby Letters of Credit, OFAC, Anti Boycott and US PATRIOT Act.

The current Federal OSHA administration is taking steps to require employers to create and enforce Injury and Illness Prevention Programs, what they refer to as I2P2. These training CDs will cover information on OSHA Recordkeeping Compliance and how to write a safety plan that complies with OSHA requirements.

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.

A training package comprising three best-selling webinars that covers all aspects of the Physician Payment Sunshine Act, including the final rule, reporting and tracking requirements, how sponsors and investigators of clinical trials can comply and acceptable and unacceptable practices.

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 90-minute webinar will highlight actual examples of travel fraud that happen in organizations and focus on internal controls that you can have in place to prevent fraud related to travel and subsistence claims.

This webinar on clinical site audit/ inspection will outline the responsibilities of the Investigator and the clinical research coordinator during and after site audits/inspections and show what you must do to ensure preparedness at all times.

This training on auditing of software vendors for FDA compliance will explain the types of audit and its use in qualifying and selecting vendors. It will discuss sample forms and checklists which may be used by the participants for observations, recommendations and remediation.

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.

Understand the regulatory framework for increasing export controls and sanctions restrictions and how to manage both for US and EU.