Compliance Training Webinars for Regulated Industries

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 SOP best practices webinar will show how to create “state of the art” SOP or review your current SOP so as to successfully manage FDA Investigators and other Regulatory Authorities Audits which can help improve and influence Audit Outcomes.

Onboarding new employees in a pharmaceutical company, which is required by law to follow the regulations governing current Good Manufacturing Practices (cGMP), creates additional complexities besides the Human Resources element. As government regulatory agencies have expectations regarding the process of qualifying employees to perform their job duties, it is essential to become familiar with these expectations and the implications that they have for the company’s training plan. In addition, companies have been penalized for failure to follow established regulations, which can create issues that can impede production, damage a company’s reputation, or ultimately lead to recalling or discontinuing product. Still, the process is not straightforward, and questions inevitably arise regarding the application of the regulations. This course will address the issues that accompany onboarding new or transferred employees and enable you to navigate them successfully.

This Software Auditing Procedure training will discussion on FDA software Standard “General Principles of Software Validation”, Actual FDA investigator software auditing techniques for software failure investigations.

This Webinar will describe, explain and clarify the differences between DHF, DMR and DHR . It will also detail the requirements and the expected contents of each record.

This Webinar will highlight the requirements of ISO 17025 and ISO 34 and explain the preparation, testing of certified reference materials along with assessment of suppliers of reference materials.

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.

This Spread Sheet Validation training/ webinar explains FDA requirements for Excel spreadsheets used in production or the quality system. The regulations come from 21 CFR §820.70(i) Automated Processes and 21 CFR Part 11.

This Regulatory compliance training will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

The Latin America Regulatory compliance requirement training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

This JPAL (Japanese Pharmaceutical Affairs Law) QMS training/webinar will explore, in detail, the QMS requirements placed on the foreign manufacturer via Ministerial Ordinance 169, Ordinance 2 and Ordinance 179.

This Japan Regulatory Filing training for life sciences is designed to provide an overview of the regulatory environment in Japan.

This Good Laboratory Practice training defines deviations and unexpected events, the similarities and differences between deviations and amendments, and will present strategies to minimize the occurrence of unnecessary deviations.

This Spreadsheet validation training will cover the use of spreadsheets to report data from the inception of the spreadsheet (user requirement specification), through the development process, validation, and use.

This Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan.

This Quality management training will review processes for integrating a reasonable level of risk management into the quality management system.

This medical device compliance training will be helped to see how to understand the similarities and differences of these two complimentary documents and how to comply with the respective requirements and develop compliant files to address. The U.S. FDA’s Design Control requirements of the QS Regulation mandate the initiation and maintenance of a product Design History File for products to be marketed in the U.S. The European Union’s Medical Device Directive and a company’s Notified Body require a Technical Dossier or Technical File to show compliance to the Essential Requirements of the MDD and associated relavant standards for product to be CE-marked and marked in those countries (and others). Attendees will be helped to see how to understand the similarities and differences of these two complimentarty documents. Attendees will be further helped to comply with the respective requirements and develop compliant files to address either or both.

This Clinical Trial training will provide a detailed review of the FDA regulations for Clinical Trials Process. This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics.

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.