Medical Device Sterilization Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

This webinar explains what actions should be taken following an unexpected positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It also addresses the actions to take when a test of sterility demonstrates unexpected growth during validation or routine dose audits. The various items that should be investigated to determine the root cause and the follow up to the investigation will be covered.

This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.

This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.

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 sterilization validation process training webinar will review the FDA or ISO requirements for tests following validation and emphasis is placed on the appropriate tests for validation, the appropriate routine tests and the frequency of testing.

This Sterilization training will provide valuable information to companies that design products for terminal sterilization with ethylene oxide.

This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.

This webinar will discuss the role of Process Challenge Devices (PCDs) both during ethylene oxide (EO) validation and during routine processing. It will explain the difference in requirements for PCD during both the processes.

Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.

This 90-minute webinar will cover general considerations for microbial control for non-sterile manufacturing areas, including attributes of an effective cleaning and disinfection program. Points to consider specifically aimed at oral solid dose (OSD) manufacturers will also be presented, including cleaning and disinfection of both product contact and non-product contact surfaces.

This course will provide a foundation for developing your technical skills related to sterility assurance.

This webinar will help the attendee gain an understanding of the requirements of current USP <85> Bacterial Endotoxin Test (BET), European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01). The webinar will provide the attendee the ability to understand the different LAL testing methodologies, choosing the best test method applicable to the product type, criticality of the BET test result as it applies to the release of a cGMP manufactured product.

This 90-minute webinar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.

This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.

This Steam Sterilization training will review the general requirements for performing a steam sterilizer validation via the “overkill” half-cycle method as described in ISO 17665 (supersedes ISO 11134). For decades, steam sterilization (autoclaving) has been an integral part in the manufacturing and laboratory processes in the medical device, pharmaceutical, and HCT/P industries.

This presentation will review the general requirements for performing EO validations via the "overkill" half-cycle method as described in ISO 11135.

This presentation is the third of three presentations on the methodologies for the determiniation of the minimum sterilization dose.

This will review how EO sterilizes, basic factors affecting sterilization, calculating the D value, Biological Indicators, the processing steps, EO residuals, and product release in a practical manner. Many companies are using EO to achieve product sterility. Whether EO sterilization is performed in-house or with a contract sterilizer the product manufacturer must be informed as to how the process works.

In this Sterilization training will review these requirements and practices for gamma and electron beam irradiation in a practical manner so the product manufacturer can better understand the application of the ANSI/AAMI/ISO 11137 and AAMI TIR 27.