Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training will cover several recommendations to improve the hospital’s due diligence when administering and dispensing narcotic drugs in a hospital setting and what steps to take to detect and prevent the illicit use or diversion.

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

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 webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.

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 presentation reviews the six levels of metdata level processing that all organizations need to be aware of and plan for. In the current days of automation in our daily lives at home, in the car and in various industries, FDA submissions in the pharma industry is next in line for more automation through metadata. We will explore examples for each of the metadata level. Metadata will be reviewed to understand how metadata has answers to key questions for logical processing. SAS tools will be reviewed to write code for more automation process.

This webinar will explore the area of training in regulated environments, its importance, and its relationship to compliance documentation. You will learn how to achieve world-class compliance, improved operational performance, improved quality, and improved employee/associate safety through training.

This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.

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.

In order to properly, effectively, and efficiently bring generic drugs and medicinal products to market, it is crucial to anyone interacting with the submittal process to understand how the process is structured and functions

The goal of pharmaceutical development is to design a manufacturing process that can produce a drug product to a consistently high quality. This webinar sets out regulatory expectations for pharmaceutical development, taking account of the risk-based approach set out in ICH guidance documents (Q8, Q9, Q10 and draft Q12). It covers some examples of problems encountered during drug development.

This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.

Annex 1 is a European mandate for Sterile Products Manufacturing but encompasses many critical utilities including pharmaceutical water. The current version is under revision and may be contrary to some Pharmacopeias. Annex 1 will be enforced by PIC/S, EMEA, and other European regulators. This is a very important subject to anyone manufacturing products either in or for the European market.

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.

Preclinical development is a critical stage of drug development that determines as well as measures the “therapeutic” doses needed and the ability to achieve these doses. Moreover, preclinical studies assess the safety of the drug at these doses.

Accelerated assessment of medicines in the EMA’s centralised procedure may be granted for treatments that are of major interest to public health. It is one of a number of regulatory mechanisms designed to provide early access to new drug treatments.