3 Valuable Webinars to describe a Compliant Program, Aspectic Techniques And Human Factor Validation of FDA
Product ID : QUAL-FDA-0001
Level : Intermediate
Qualification of Suppliers and Contract Manufacturing Organizations
Presented by Edwin Waldbusser
Suppliers and CMO’s must be selected following a rigorous formalized procedure. This webinar will describe a compliant program based on regulatory requirements. Phases of supplier and CMO selection from initial telephone inquiry to the quality survey to qualification audit will be explained. The qualification audit will be described with key points to evaluate explained. How to deal with uncooperative suppliers will be explained.Understanding Aseptic Technique and Cleanroom Behavior
Presented by Danielle DeLucy
Aseptic technique, in sterile compounding, contributes to preventing microbiological contamination. Aseptic technique is being used to provide safety, efficacy, and sterility to the products that are sterile in nature, especially when it comes to various patient injections. This course by expert speaker Danielle DeLucy will benefit those Aseptic operators, Aseptic sample handlers, personnel who work in a Biological Safety Cabinet (BSC) and their management and Quality Assurance counterparts, in highlighting how to operate in a cleanroom environment, proper facility design, proper personnel gowning, and the equipment needed to conduct environmental monitoring. Cleaning, Gowning, and proper methods of contamination control will be reviewed along with why cleanrooms are designed the way they are. In addition, this course will review how Quality Systems help define requirements for aseptic technique and clean rooms and how to properly maintain these environments.
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.
Instrumental liquid chromatography is an analysis that is widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.
Edwin Waldbusser retired from the industry after 30 years in management of the development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems, and inhalation devices. His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control, and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with an emphasis on design control, software validation, risk analysis, and human factors analysis. Ed has a B.S. Mechanical Engineering from NYU and an M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents. He is also an owner of www.meddeviceadvisors.com which offers over 80 easy to customize medical device Quality System SOP.
John C. Fetzer has had over 30-years of experience in laboratory compliance, including developing methods, writing SOPs, training, and auditing. He has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.
Danielle DeLucy, MS, is an owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices, and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility.
This webinar package gives you access to 3 webinar courses to brush up your knowledge on the Qualification of Suppliers and Contract Manufacturing Organizations, Understanding Aseptic Technique, and Cleanroom Behavior, Method Validation of HPLC/ UPLC Methods.
The webinar format is 1-1.5 hours of audio-visual presentation, including a brief Q&A session.
This webinar bundle includes below 3 recorded webinars: