FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.

Attendees of this webinar will learn specific concepts and formulas commonly used to measure the ability of a process to produce output within customers’ specification limits. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the various types of process data (attribute or variable).

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.

In this webinar, you will learn just how cyberattacks threaten medical devices and how industry is currently responding to them. We will discuss the many ways of preventing and mitigating the cybersecurity risk, and about the industry best practices that can help your company do the same.

IATF 16949:2016 consists of ISO 9001:2015 plus additional requirements for automotive suppliers, and many of these features have universal as opposed to automotive-specific applications. ISO 9001 users can benefit by adding them to their own quality systems as well.

ISO 11135:2014: “Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices”, defines the latest requirements for the validation of Ethylene Oxide sterilization of medical devices, the sterilization chamber, and sterilization controls. This webinar will use ISO 11135 as a basis for a field-tested approach to sterilization validation and its documentation, including the chamber control software.

ISO 14971:2019 requires an overall Benefit-Risk Analysis but many companies struggle with constructing the rationale for demonstrating overall benefits outweigh overall risks. This webinar will provide one systematic approach which has proved successful for approaching the analysis.

Almost two years ago the US FDA announced new steps necessary to modernize FDA’s 510(k) clearance pathway, but companies have been slow to respond, leading to unnecessary delay in achieving marketing clearance. This was reiterated one year ago in the FDA’s Medical Device Safety Action Plan and the related Draft Guidance Document. These steps are viewed by the Agency as a top priority, and provide insight into the Agency’s thinking about what a 510(k) could do to advance medical benefits to the patient.

Within the Pharmaceutical Industry, the changeover from one product to another on a filling/packaging line, although relatively a simple concept, has significant implications from a regulatory standpoint if cross-contamination is permitted to occur. Preventing cross-contamination requires a precise accountable process to be properly executed.

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

This equipment qualification webinar will discuss the requirements for IQ, OQ, and PQ protocols. It will train about the various components of each protocol, Proper language for documenting qualification testing including how to Collect data, conduct tests, and obtaining all necessary documents.

Attend this course to prepare for and understand what will happen during a Drug Manufacturing Inspection for Surveillance Inspections. It will explain the FDA criteria to perform a For Cause Inspection.

Attend this course to learn the rationale, strategies and flow on how to plan for an FDA inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.