Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.

This online training will offer an overview of what Health Canada considers to be a Natural Health product (NHP) and review Canadian regulatory requirements for Natural Health products. It will compare Canadian requirements with U.S. FDA requirements for marketing and labeling dietary supplements and convey an understanding of how they differ.

This 2-hr webinar on DEA Due Diligence will cover several recommendations to improve the Corporate Due Diligence when controlled substances and regulated chemicals are purchased by their customers and the steps that can be taken to detect and prevent the illicit use or diversion of any narcotic drug sold to customers.

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

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.

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.

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 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.

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.

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.

This webinar will discuss the risks in IV sterile compounding and how to mitigate those risks. We will review the safety requirements in USP <797> and USP <800>, to ensure the safe compounding of CSPs and protection of the patient and compounding staff.

The consequences of an immune response to biologicals, range from transient appearance of antibodies without any clinical significance to severe life-threatening conditions. Understanding why an immune response is generated, how to detect or predict its generation will help in designing products that will be efficacious and therapeutic.

In response to the global coronavirus pandemic, the UK’s MHRA has published guidance designed to protect the drug supply chain. The scope of the guidance is far-reaching (see below for details) and includes temporary changes to GMP and GDP expectations as well as some licensing arrangements.

The U.S. Food and Drug Administration’s is responsible for regulating the Over-the-Counter Drug market. In this webinar, attendees will learn what is required to market and sell an OTC drug in the U.S. It will provide information on what is an OTC drug, how they are regulated, the different types of products, how to read a Monograph, whether or not a certain ingredient can be used, the parts of a proper label, and a variety of other important requirements needed to be successful.

This webinar provides some practical and useful answers to the question: “What Strategies Should I Use to Speed Up Formulation Development?” A strategy based on QbD principles that have been proven to effectively and efficiently develop useful multi-component formulations is presented in this webinar. A critical goal is the creation of formulation understanding and design space that will consistently produce a product that meets specifications with minimal risk of failure. This strategy will be described and discussed along with several examples of its use.