Biotech Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).

This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.

In this training program, attendees will learn how process robustness tools and metrics can be utilized to enhance process understanding and control. The new FDA paradigm is shifting to the expectation that organizations certified by other standards such as ISO and EFfCI demonstrate process robustness. It is the obligation of the primary pharmaceutical provider to ensure process robustness throughout the supply chain.

Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.

This webinar will review FDA’s regulations related to suppliers in manufacture of drugs, biologics and medical devices. It will discuss the current regulations, guidance documents and best practices for supplier management and enforceable quality agreement using case studies for a variety of scenarios. Common FDA audit findings will be discussed.

This training program will dispel mistaken paradigms regarding the risk based approach to water system lifecycle. It will detail how to eliminate variability – the cause of most deviations. Attendees will learn how to capitalize on the advantages of online analytical instrumentation (chemical and microbiological rapid methods).

This course will detail various sterilization methods and various approaches for the validation of a sterilization process.

This regulatory training will help attendees understand key benefits for implementing and maintaining an effective global regulatory plan. Attendees will also gain exposure to the elements and a methodology for global regulatory plan development and maintenance.

This training program will prepare attendees for new regulatory requirements that will arise and apply to your cell line, even if it was made before the requirements were in place. One of the first steps in a recombinant project is the development of the cell line to produce the protein of interest, generally years before the product will be filed for licensure. How do you peer into the future to make sure that when the day comes to file for approval that you have collected and saved all the necessary information on that cell line and your master and working cell banks? Don’t make the mistake of assuming that you can find all that information years from now – create a plan to ensure everything is documented and saved.

This webinar will focus on the microbiological element of non-sterile manufacturing cleaning validation and the need to design a robust cleaning routine. It will address the different pharmacopoeia regulations and current regulatory trends. It will also cover the theory in setting the baseline profile and limits along with determination of routine testing.

This training program will discuss each of the critical aspects of freeze drying and the related effects of variables. The course will also discuss sublimation rate variability, heat transfer, loss of protein activity, and freezing effects on primary drying.

This webinar will highlight rules governing HCT/Ps using case studies. Practical suggestions for compliance with FDA requirements and tips to negotiate with the agency regarding disputes with interpretation of the law will form the core of this training session.

This training program will discuss why it is important for you to be better aware of and to become better acquainted with FDA inspection best practices. In particular, the webinar will detail a list of Dos and Don’ts before, during and after the inspection.

This training program will detail best practices for documentation, list types of documents, and highlight key documentation requirements. Documentation is essential where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are a set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.

This training program will provide attendees with an introduction to FDA’s veterinary drug approval process. It will also discuss key components of an appropriate animal field study needed to support new animal drug approval and explain how jurisdiction is split between various federal agencies in certain cases.

This webinar will teach attendees how to prepare for, manage, and follow up on FDA inspections. It will discuss common pitfalls to avoid during an inspection.

This webinar will provide an overview of regulations for the use of social media for promoting FDA regulated products. Attendees will learn how to comply with these regulations and avoid enforcement actions.

This webinar will clarify the cleaning and material handling requirements outlined in USP 797 and present additional best practice guidelines. It will discuss principles related to the selection, preparation and use of cleaning, disinfection and deactivation agents. The correct sequencing of critical activities related to daily and monthly cleaning of both primary and secondary engineering controls will be presented as well.

This webinar will cover in detail the current Good Manufacturing Practices (cGMPs) regulations for pharmaceutical products. Attendees will learn how to comply with these FDA regulations and avoid pitfalls.

This webinar will explain how to incorporate a quality system into the validation process to reduce cost and ensure compliance. It will cover the analysis, design and initiation phases, including full implementation of the incorporation.