Biotechnology Contamination Control Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

This 60-minute webinar will show how you can design a robust microbiological audit program for pharmaceutical and biopharmaceutical product manufacturing, that effectively assesses your facility and that of your supplier to ensure your facilities and products are free from microbial contamination.

This training program will help attendees understand the sources of mycoplasma contamination and how to minimize the occurrence of contamination. The regulatory standards for testing will be described as well as the methods of mycoplasma detection and the resources for testing. At the conclusion of this webinar, attendees will have knowledge of the importance of mycoplasma contamination testing and how to successfully perform the tests in their company’s setting.

This webinar will cover the regulatory perspective in testing raw materials for microorganisms and how you can manage the risk of raw materials being the major source of microbial contamination in your medical product manufacturing process.

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 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 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 provides a thorough demonstration of what information can be extracted from a surface swab recovery study for maximum leverage in a cleaning and cleaning validation program.

This microbial excursions training will address microbial excursion and the best practices for troubleshooting them. Attendees will gain a new understanding of the complexity of troubleshooting outbreaks and contamination issues based on real life experiences and details of specific excursion.

This webinar on objectionable microorganisms will show how to identify and prevent objectionable microorganisms that are beyond the ones outlined in USP <1111>. Attendees will learn the clinical implications due to presence of objectionable microorganisms.

This 90-minute webinar on personnel practices and microbial control in Pharmaceutical, Biotech, and Medical Device manufacturing will cover effective ways to train personnel on gowning and personnel practices in cleanroom operations to limit contamination. This webinar will also address controlling microorganisms on process equipment and product contact surfaces.

This contamination control training will focus on how to use the EM data appropriately as part of a contamination control plan and also discuss about Designing and Managing a Microbiological Monitoring Program.

This biotech training will provide valuable assistance to all regulated companies (Pharma, OTC etc) that manufacture non-sterile products.

This Water system compliance training/webinar focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches.

This Water system compliance training will guide you through the changes to implement to Validate Water system and better understanding of quality specifications and process control levels, as well as the microbiology of water systems.

This Objectionable Microorganism training will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

This water compliance training/webinar covers the reasons for diverse types of flora from one type of water to the next, the differences in the compendial water test methods, the advantages and disadvantages of harmonization.

This Water System Compliance training will review what biofilm is and how it grows and will cover how it affects just about every kind of unit operation used in today's water systems.

This Contamination-Control training will provide valuable assistance to companies that need to validate their cleaning and disinfection programs.

This Biopharmaceutical Compliance training provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Designing an effective disinfectant validation program to meet FDA and EMEA scrutiny. This webinar provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Current 483's, Warning Letters, and Field Experiences will be conveyed that allow end users to determine that best methods to validate their products against their isolates.