FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

This session will include the requirements for all of the complaint handling responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.

This course provides medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

Attendees of this webinar will learn statistically valid methods for using small sample sizes and for using lots as few as 3 when validating processes or products.
The focus of this webinar is on providing the information needed for attendees to understand the concepts of risk in relation to process validation and to be able to compute sample sizes and lot sizes according the desired or required specification criteria or the process or product.

This webinar provides an overview of FDA’s requirements for vendor management and oversight for pharmaceuticals, biologicals, and medical devices.

This session will discuss the requirements for Management Controls, including organizational structure, internal audits, establishment of a quality policy and confirmation it is being followed, establishment and contents of a quality system.

This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.

This course teaches tools and techniques that can be employed to get to the root causes of unexpected quality events, and help resolve them in a lasting, GMP compliant manner.
The course examines actual situations, guiding participants in effective investigation resolution and determining solutions to effect proper corrective action.

This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems. It will cover the common problems from FDA 483 observations and warning letters and teach you how to avoid them.

Many of the commonly used statistical tests and calculations of chart limits (or other measurements) require that the data be “normally distributed”. This webinar will show you how to check for normality in your data and apply transformations to non-normal data. You will also learn tools and concepts to understand when a transformation of data is, or is not, necessary.

This webinar will discuss the steps to perform a good fact-based investigation, tools, and when to use them for analyzing facts gathered during investigation to identify one or more root causes and Tools for determining appropriate actions to take to address identified root cause(s).

This webinar reviews the requirements for good manufacturing practices for active pharmaceutical ingredients. It is based on the requirements of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and its document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

This workshop is designed to train the principal investigators charged with executing deviation investigations. It will present tools and how they are used to gather facts about a problem, evaluate those facts to determine root cause, develop corrective actions and to tell a coherent story of the execution of the deviation management activity.

In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. Attendees will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents and also they will learn how to react to discrepancies found in these records.

The purpose of this presentation is to provide an overview of the regulations and guidance applicable to managing Recalls of drugs, biologics and devices in the United States. It will describe the quality management system components that are necessary for supporting recalls and encourage you to prepare for a recall well in advance of any actual need to execute a recall.

Labeling, Advertising and Promotion of drugs, biologics and medical devices are heavily regulated and aggressively reviewed on behalf of the regulators such as FDA, FTC and other Federal Authorities. This course provides an overview of label development, building a Target Product Profile, the label’s impact on advertising and promotion, and recent changes in how these areas are monitored and enforced.

This course will describe the preparations needed for and the process during and after an FDA inspection. The legal authority will be discussed along with the documents and facilities FDA is entitled to see.

In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.

This course will focus on Regulatory Inspections and Quality Audits. It will cover Health Authority inspections as well as internal Quality Audits and also managing corrective action plans that can result from audits.

Successful cannabis product development requires having the-end-in-mind regarding excipients-cannabinoids compatibility, shelf-life/product stability and bioavailability of cannabinoids. This webinar will utilize presenter’s expertise and experience in both pharmaceutical and cannabis industries to provide guidance and examples on successful product development. You will learn various techniques to successfully initiate and optimize formulation for products containing cannabinoids.