Compliance Training Webinars for Regulated Industries

This training program will highlight why a vendor questionnaire is the keystone your vendor management program is built on. The course will help ensure attendees get the whole picture and determine appropriate controls for information security and privacy.

This training program will guide attendees in implementing and complying with the requirements of ISO 27001:2013. ISO 27001 is an international standard published by the International Standardization Organization (ISO), and it describes how to manage information security in a company. The latest revision of this standard was published in 2013, and its full title now is ISO/IEC 27001:2013.

This webinar will help managers establish best practices for managing their workforce using sound performance management techniques, especially documentation of poor job performance and code of conduct violations to best support terminations. Learn how HR can coach their executives and managers on how best to work through their performance management strategy.

This training program will provide attendees with an introduction to FDA’s veterinary drug approval process. It will also discuss key components of an appropriate animal field study needed to support new animal drug approval and explain how jurisdiction is split between various federal agencies in certain cases.

This training program will discuss the basics of the Medical Device Reporting (MDR) regulation and review the process for preparing and submitting Electronic Medical Device Reports (eMDRs).

This webinar will discuss the disclosure requirements for clinical investigators under the Sunshine Act. It will discuss the details of the processes; provide templates for reporting formats; and timelines for reporting.

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 webinar will focus on the regulatory and design requirements for an effective change control system in the pharmaceutical industry. Attendees will learn the role and importance of change control system in implementing an effective quality system.

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.