Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar provides attendees with an introduction to FDA Import Alerts and what they are, examine why they are issued, show you where to locate them and how to determine whether a company or product is on one, and finally, provide strategic recommendations for removal from an alert.

Prices for some products can vary from around $1,000 per pack in the US to one third of that for the certain product in South East Asia. In EU markets, prices are in between these two extremes and the same product can sell for anything between one-half and two thirds of the US price. The webinar sets out to examine these difference, explain how the price variations have arisen and aims to provide participants with some insights into ways of coping with them when moving into new markets.

Attend this training to learn how to implement a Human Error Reduction Program at your site. It includes practical tools and explains how to measure effectiveness to continuously improve human reliability at your site.

This DMFs (Drug Master File) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.

The Canadian Drug Approval Process is misunderstood by many and considered harsh by some. We will explore reasons why the Canadian market should not be overlooked and the benefits of including Canada in strategic drug development initiatives. We will share insights and practical examples that facilitate a positive, proactive and transparent interaction with Health Canada, and provide strategies for avoiding obstacles and managing them efficiently should they occur.

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Process Analytical Technology was released by the FDA as a 21st century guideline in September 2004. This guidance was released to help the pharmaceutical industry with real-time release, process understanding, and using the process to ensure all CPPs and CQAs meet compliance, URS, and SOPs. The use of PAT can alleviate strenuous validation procedures by using the process as the function of validation.

This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.

This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.

This webinar provides some practical and useful answers to the question: “How to Detect Lack of Data Integrity?” Humans, equipment or both can be the source of lack of data integrity. This session discusses both types of data integrity sources and introduces the assessment of “data pedigree” as a concept that puts focus on the types of data integrity issues and analytical and statistical methods for detecting data problems. Pharma and biotech case studies are used throughout the presentation to illustrate how the various approaches fit together.

This webinar provides insights into the European generic market, its regulatory procedures and the impact of the differing national pricing and healthcare environments that have shaped the individual country markets.

This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes. Several types of hypothesis tests will be covered such as 1 and 2-sample means tests, tests of variances, and tests of proportions. Equivalence tests will also be discussed. The importance of selecting appropriate sample sizes will be stressed.

This seminar will give you a snapshot of what is current, what is coming and what this means to anyone who is currently developing Drugs and other Health Products for the Canadian market. The focus will be on drugs, biologics and medical devices.

Drug-Induced Liver Injury (DILI) is one of the most common adverse drug event leading to drug candidate termination and post marketing drug withdrawal. This webinar will describe the known mechanisms associated with DILI and will inform modern methods used to identify and assess risks. Importantly, it will describe mitigation strategies that may be successful in minimizing DILI risks.

This webinar is on microbials and their mitigation in pharmaceutical water systems. Microbials, as determined by traditional inoculation and incubation, delineate acceptance or rejection of pharmaceutical water for production and usage. Microbes and bacteria have different states as they develop into biofilms. Mitigation of these single cells or colonies is via sanitization methods. All Pharmaceutical water systems regardless of which pharmacopeia is enforced, must adhere to stringent values of colony forming units (CFUs) per ml.

This process capability analysis webinar will discuss the relationship between variation and accuracy, and process yield, short term versus long term variation, non-normal distributions and how to perform a process capability study.

This webinar provides some practical and useful answers to the question: “How Large a Sample Do I Need?” Methods for determining appropriate sample sizes in raw materials acceptance, finished product release, process and product development experimentation and process monitoring for process stability and capability is discussed. A comparison is made of the square root (n)+1 sampling rule with the ANSI Z1.4 sampling system for process monitoring including incoming raw materials, in-process manufacturing and finished product. The value of a systems approach to sampling and practical tips, traps and guideline for sampling is discussed. The presentation includes portable methods for making power calculations for experimental design. The concepts and methods involved are introduced and illustrated with pharmaceutical and biotech case studies and examples.

Pretreatment technology is quite diverse with many tried-and-true options. This seminar describes and identifies new and innovative technology which can eliminate many traditional pretreatment modules. The new ISO-22519 elucidates on many pretreatment issues which will be discussed. ISO is a voluntary standard which may be instituted by a company and is often quoted or cited by a regulatory agency. This presentation offers ideas, physical modules, and descriptions of alternative pretreatment options.