Regulations & Guidances 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.

Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.

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 training program will guide attendees on how to best deliver water from a high purity water distribution system. Attendees will learn to capitalize on the advantages of online analytical instrumentation and understand the value of rapid microbiological methods. The program will also offer an understanding of real-time release of water.

This FDA training program will guide attendees on how to get the best advice from FDA with the proper actions before, during and after your FDA meeting.

This training program will enumerate the inspection process for API, drug and device manufacturers and summarize recent changes. It will guide attendees on preparing staff for the new FDA inspections and discuss the role of exit meeting to avoid enforcement.

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 webinar will help you understand the rationale for Generic Drug Product Development via an ANDA Filing and the potential added value of a Paragraph IV Application, exclusive to the US market.

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 discussion is geared for the pharmaceutical industry. It will provide pharmacovigilance (product safety) departments with solid ideas to help them prepare for and manage a health authority inspection. Medical information, research and development and quality and compliance groups in the pharmaceutical industry would benefit from tips discussed in this session as well.

This webinar will discuss the disclosure requirements for clinical investigators under the Sunshine Act. It will discuss the details of the processes; provide templates for reporting formats; and timelines for reporting.

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 help industry better understand FDA regulations and its role in governing opioid medications. Among other key topics in the area, it will also discuss recent FDA approvals for opioid medications.

This webinar will focus on the process of establishing an environmental monitoring program for non-sterile manufacturing facility and the need to design a system and routine that will satisfy the expectations of the global regulatory agencies. It will also address the different pharmacopeial regulations and current regulatory trends.

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 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.