FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

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 webinar will provide an in-depth review of enforcement actions taken by the HHS OIG over the previous two months. We will also briefly review the Anti-Kickback Statute (“AKS”), discuss any new safe harbors, and OIG Advisory Opinions that have been issued.

This Quality inspection training will teaches tools and techniques that can be employed to get to the “root cause” of unexpected quality events, and to resolve them in a manner such that they stay resolved in a GMP compliant manner.

This webinar will provide valuable guidance to regulated companies in development and implementation of Design Control Planning and Techniques for new or heavily changed product development under 21 CFR 820.30, "Design Control", and ISO 13485 7.3. Also regulatory compliance proof of "progress against plan", and other activities requiring a planned documented rationale. It should be an important part of a company's IP (Intellectual Property).

In the IT world, contracts and Service Level Agreements (SLAs) are often very standard, cookie-cutter agreements, and what I have found in my decades of consulting related to GxP systems, they are not scrutinized appropriately. This will likely be a large capital investment or expense to the company, and it is clear that the experiences of many in the Life Science industries have proven less than acceptable.

In today's rapidly evolving scientific landscape, the 90-minute webinar titled "Human Error and Documentation Practices in Good Laboratory Practices (GLP)" offers an essential exploration of the critical role that accurate and complete documentation plays in maintaining the integrity of research processes. Delving into the heart of Good Laboratory Practices (GLP), this enlightening session uncovers the intricate relationship between meticulous documentation and the reliability of scientific findings. Over the course of the webinar, attendees will gain a comprehensive understanding of the multifaceted challenges posed by human errors within laboratory environments. With real-world examples, the webinar illustrates the potential consequences of inadequate documentation, underscoring the significance of precise record-keeping in safeguarding data integrity, research reproducibility, and regulatory compliance. Attendees will also glean valuable insights into common documentation errors and pitfalls, as well as invaluable strategies for bolstering documentation practices. From proactive measures and standardized procedures to fostering a culture of clarity and collaboration, participants will leave equipped with the tools to elevate their documentation practices and contribute to the overall credibility of their scientific endeavors.

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.

Data integrity refers to the accuracy, completeness, and consistency of data over its entire lifecycle. Data integrity is crucial for any organization as it ensures that the data they rely on to make decisions is trustworthy and reliable. This topic discuss the importance of data integrity in regulated industries, such as pharmaceuticals and medical devices.

This system based inspection for Laboratory Control System training/webinar includes measures and activities related to laboratory procedures, testing, analytical methods development and validation or verification, and the stability program.

This FDA Inspection training will provide you an understanding of how the FDA conducts systems based inspections, and will review examples of FDA 483 observations, so you can better prepare for your PAI.

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 FDA inspection training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.

In this FDA audit & Inspection training we will focus on ideas that will help identify areas of improvement before the formal inspection occurs. Further, you will learn techniques that will enhance your effectiveness during the audit execution.

This FDA audit & inspection training will provide your firm with key insights on how to perform superior supplier audits. It will help you uncover purchasing controls GMP violations.

This FDA compliance training will provide valuable assistance to all new & existing OTC drug firms that are regulated by FDA due to their domestic USA sales.

This FDA compliance training will guide you through Software Verification and Validation process in FDA-Regulated Industries. U.S. FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based software V&V. Starting with a Project Validation Plan, evaluating its elements against ISO 14971:2007 hazard analysis / risk management, allows development of meaningful product / process validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources (personnel, budget, time). Two matrices / models simplify regulatory requirements for “as-product”, “in-product”, process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. QMS and 21 CFR Part 11 require yet another approach.

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 21 CFR Part 11 training will deliver concrete guidance which will provide a roadmap for compliance that will have immediate benefits, withstand FDA’s changes to Part 11, and discuss the new Obama administration approach to enforcement.

The FDA Audit inspection training defines the laboratory environment; points out problem areas and common pitfalls; and details solutions and also details how to prepare the Laboratory staff for an Inspection as well.

This CAPA training will focus on defining the specific steps to be taken when implementing a CAPA system and review some of the possible pitfalls one may encounter when implementing a CAPA system. This presentation will begin by defining risk in compliance and the methods, which can be used to mitigate risk. One of the methods defined by the regulators and the industry is “Corrective Action Preventive Action” otherwise referred to CAPA. We will first define what we mean by risk. We will then explore the factors associated with risk in compliance. We will also explore risk causing events and how to address them. A review of risk severity/level will then ensue. Upon completion of risk part of the presentation we will define what a CAPA system would look like.

The presentation will focus on CAPA as it applies to risk mitigation. We will define what we mean by a CAPA system. We will further define the tools CAPA uses during implementation. Finally an overview of a CAPA system will be presented and a CAPA approach will be proposed. The approach will focus on defining the specific steps to be taken when implementing a CAPA system and review some of the possible pitfalls one may encounter when implementing a CAPA system. We will also review some of the benefits which may accrue by having a robust CAPA system in place.