FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

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 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.

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.

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.

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.

This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.

This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.

If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. It is important to interact with the FDA employee in the most productive manner. But there is a variable you must deal with that will determine how productive your interaction is. The variable is the FDA employee. That is the purpose of this webinar.

This webinar provides some practical and useful answers to the question "What Kind of Statistical Methods and Tools Does the FDA Want Pharma to Use?"

FDA’s guidances and regulations have emphasized the use of statistics for many years. Statistical thinking and methods is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many. This presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.