Automating Assays for Clinical Diagnostics

Presented by Todd Graham

With this webinar, you will be able to understand the steps needed to transfer, validate and maintain an automated assay in the laboratory. First, a key understanding of the various steps technicians performs on the bench is necessary, as certain methodologies are difficult to translate onto automation. Then the procedure must be made to work on the automation in a way that is reliable and repeatable. Validation studies must be performed and properly scaled to make sure that the automation works reliably, and that any issues involving the method of transfer have been properly resolved. Finally, developing a quality assurance plan in concert with both the assay team and the manufacturer of the automation equipment will be discussed, as quality methods must adapt to the new technology to maintain proper quality.

How Successfully Apply for a Breakthrough Therapy Designation

Presented by Carolyn Troiano

After attending this webinar, you will understand:

Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach

Presented by Jerry Dalfors

From the topics listed above the areas covered provide the mathematical means of developing and proving the sterilization process is effective and does not generate a problem for heat liable products.  

Quality Control for Analytical Materials used in Microbiology Laboratories

Presented by Michael Brodsky

Upon completion of this session, attendees will learn:

Trial Master File – Clinical Data Systems

Presented by Carolyn Troiano

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). This seminar will help you understand in detail the new requirements for trial master files.

Method Validation of HPLC/ UPLC Methods

Presented by John C Fetzer

Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that do regulatory-compliance work. For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.

To meet US EPA or FDA requirements, a method must meet many stringent requirements. The more important of these for specific analytical methods are method validation and instrument validation. To not do so is a non-compliance in which any data is not usable or reportable.

Todd Graham is a clinical laboratory scientist for a large hospital system in the New York Tri-State Area as well as a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world and R1 Research Level Universities.

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid and other FDA-regulated industries.

Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.

Michael Brodsky has been an Environmental Microbiologist for more than 44 years. Michael accepted the position of Chief, Environmental Microbiology, which he held until he changed his career path in March of 1999. He is currently operating as Brodsky Consultants, an independent microbiological consultant in food and water safety, laboratory accreditation and quality assurance.