Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.

This webinar will discuss the steps to guide the technology transfer for the successful implementation, ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company.

This equipment qualification and validation webinar will help you to understand the various processes of equipment qualifications (IQ, OQ & PQ) and process validation steps (when, what and how to tests) in a manufacturing process. It will also highlight all the requirements of FDA cGMP regulations that all equipment to be qualified and all manufacturing processes to be validated if problems are encountered changes have to made and periodically as necessary.

This webinar will discuss the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place.

Structure Alerts, also known as toxicophores, are classes of chemicals, functional groups or substructures that, when present in drugs or drug candidates, have been linked to preclinical toxicity and/or adverse drug reactions in humans. This webinar will define and describe many of those structure alerts and outline the mechanisms that have been associated with their toxicity. Mitigation strategies will also be discussed.

This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.

This webinar distills learnings from more than 20 years spend providing guidance to biopharmaceutical companies and related stakeholders. You will learn how to find and evaluate branded and generic entry opportunities, how to anticipate changes in demand for drugs, and how to add value to your partnerships.

This laboratory compliance training will teach you how to validate an analytical method under the GLP requirements. It will cover in detail the criteria for the validation of an analytical method including statistical and documentation requirements.

This webinar will cover in detail the FDA Compounding Pharmacies Guidance and will review the Aseptic Guidance document. It will help Compounding Pharmacies understand what actions are needed in order to prevent insanitary conditions.