Product Id: 703875
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.
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
Product Id: 703885
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.
Product Id: 704429
This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are.
Product Id: 704377
This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.
Product Id: 705317
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.
Selection and Auditing of Analytical Contract Laboratories: Best Practices for Pharmaceutical Scientists
Product Id: 705169
This webinar on selection and auditing of analytical contract laboratories will guide the participants to understand the process of CRO selection for analytical testing. Attendees will gain knowledge on the basic principles of quality auditing of a CRO; including audit planning, scheduling, conducting an audit, and the audit report process.
Product Id: 705279
This training program will discuss in detail the requirements of Revised Total Coliform Rule (RTCR) including its history and background, key provisions, comparison with the TCR (Total Coliform Rule) and much more. It will also describe the best practices to comply with the RTCR requirements.
Product Id: 705078
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.
Product Id: 705060
This webinar will give you the tools you need to maintain a quality supply of media and reagents in a variety of microbiology laboratories. A thorough understanding of the variety of challenges necessary in maintain quality media and reagents will be brought to the fore. This will allow you to perform microbiology testing with confidence.
Product Id: 705072
This webinar you will discuss how to help your organization get a better handle on what is an “objectionable microorganism, ” exactly how “objectionable” it really is and what you can do to minimize the risk if you find one in your process or product.
Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)
Product Id: 705018
This webinar training will benefit manufacturers of manufactured products to achieve an effective, robust and compliant SOP and STM which will result in a cost effective and efficient manufacturing and testing of products. A well planned and written SOP or STM will reduce the incidence of out-of-specification (OOS) results, failure, product non-conformances, deviation and invalid assay investigations.
Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?
Product Id: 703058
This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.
Product Id: 705008
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.
You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals
Product Id: 702964
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.
Product Id: 704361
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.
Product Id: 704272
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).
Product Id: 703072
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.
Personnel Practices and Microbial Control in Pharmaceutical, Biotech, and Medical Device Manufacturing
Product Id: 702446
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.