Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.

This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.

This Method validation protocol training will discuss the regulatory requirements of analytical test methods, the USP good documentation practices <1029> and how to establish acceptance criteria for validation.

Amid several other critical discussions, this training program will detail FDA and international requirements for system suitability testing; SST in comparison with equipment qualification and quality control sample analysis; critical parameters for SST in EP and USP; recommendations for implementing the updated <621>; and developing an SOP for system testing.

This SQM webinar will discuss how to establish a Supplier Quality Management program from selection to approval, the ON-going maintenance and disqualification of suppliers will be explored through definition of supplier classifications. How to build risk management into the process will be discussed. The webinar will explore the use of Quality Agreements to manage suppliers.

In this Water System Webinar the author will explain the process he uses as a consultant for investigating and solving water system or product contamination problems with water organisms. Case studies of real life problems he has resolved will be presented to illustrate the process.

This 90-minute training will discuss the requirements of ICH for using testing and stability data to set specifications for drug substances and drug products including use of special stability studies. Attendees will also learn the requirements for changing specifications through the lifecycle of the product.

This Drug GMP webinar will review the pharmaceutical GMP regulations and discuss how to avoid deviation from them, what to do when deviations do occur and what happens when the regulations are not followed. It is crucial that all employees involved in pharmaceutical quality be familiar with these regulations and review them on a regular basis.

In this 1-hr webinar you will learn how to differentiate and draw boundaries for GMP and GLP practices if done in same laboratory and how to transition a procedure in development to one used routinely.

This webinar will evaluate guidelines for recreational drug use during breastfeeding, how to counsel mothers who are breastfeeding and using recreational drugs, including marijuana and also Evaluate ethical concerns regarding marijuana use.

This Biologic stability webinar will discuss the issues present during design and implementation of stability program for large molecule therapeutics. We will discuss the design and validation of stability indicating methods and expiry dating.

This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.

This equipment cleaning validation webinar will explain cleaning validation program steps, cleaning agents selection, documentation, cleaning method set up and how to reproduce cleaning validation program and various simple but powerful tools for achieving an in-depth Cleaning Validation Program, and continuous monitoring that meets FDA expectations.

This GMP training will elucidate the key elements of world class QA and compliance practices specifically for animal health manufacturing companies. These practices support a robust quality system, ensure the firm’s quality standards remain current, and inform the GMP auditing and training processes.

This Medical device complaints handling webinar will discuss the best practices of complaint handling and how to include it in your CAPA program and how to apply risk management to the complaint handling system.

This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.

This project and alliance management webinar will present tools valuable for planning a project, identifying required outsourced activities, selecting a CDMO, monitoring/controlling an outsourced project, and communicating project performance to leadership.

This webinar will provide you with an Update on FDA’s judicious use strategy using antimicrobial drugs in Animal Feeds.

This pharmaceutical water systems webinar training will discuss what you should do when your monitoring data tells you that you may have a significant biofilm problem. It covers how to verify that the data and your interpretation of the data are correct, as well as the location of the problem which gives you clues as to what caused the problem and its impact on manufacturing and product.