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Standadardizing Operations to Eliminate Human Error Potential in Life Sciences Operations
Human Error occurs in all settings. In the world of pharmaceutical manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients. Human is a frequent occurrence in pharmaceutical manufacturing. It occurs even ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
- Mar 19, 2019
Adopting Price Controls for U.S. Prescription Drugs: Federal Policy Outlook for 2019 & Beyond
The cost of prescription drugs in the United States remains a hot-button issue for policymakers and consumers alike The vast majority of the public sees drug prices as unreasonably high with one in four people taking prescription drugs reporting difficulty ...
- Basic & Intermediate
- 60 Mins
- Dennis Weissman
- Mar 19, 2019
Risk Based Approach to Auditing Quality Suppliers and Vendors
The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implem ...
- Basic & Intermediate
- 90 Mins
- Joy L. McElroy
- Mar 19, 2019
FDA – Is your cGMP Water System READY for their VISIT
Pharma cGMP Water Systems are very critical to the safe production of patients modifications. Several Departments are required for continued High-Quality operations. These include Quality, Manufacturing, Maintainence and Validation on a daily basis. This prese ...
- Intermediate
- 90 Mins
- Peter T. Vishto
- Mar 19, 2019
Pharma Curriculum Development Using a Learning Management System (LMS)
Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date. They often boast great functionality but also have limitations that must be overcome for ...
- Basic & Intermediate
- 90 Mins
- Michael Esposit
- Mar 20, 2019
PK/PD Studies in Drug Discovery and Development
Pharmacokinetics (PK) describes the time course of drugs in the organism i.e. the processes that a drug undergoes after administration. PK, therefore, assesses the absorption, distribution, metabolism, and excretion of new chemical entities. In other words, ...
- Basic
- 60 Mins
- Stefano Persian
- Mar 20, 2019
FDA Regulations for Pharmaceutical Current Good Manufacturing Practice (cGMP)
This webinar will review all the sections of FDA cGMP regulations. Regulation text and examples from the instructor’s experience will be presented. Warning Letters and Inspectional Observations will be used as examples of what not to do.
- Basic
- 90 Mins
- Loren Gelber
- Mar 26, 2019
Technical Writing: Best Practices
Technical Writing generally conforms to Good Documentation Practices (GDocP). This term describes standards to create and maintain documents. The term is primarily associated with the pharmaceutical and medical devices industries but applies to documents creat ...
- Basic
- 60 Mins
- Robert Peoples
- Mar 27, 2019
Environmental Monitoring for Pharmaceutical Clean Rooms
This webinar will discuss various broad and critical aspects of an effective EM program such as the Phases of a cleanroom EM Program, Pre-Monitoring of a Cleanroom prior to Facility Validation, Facility Validation, Implementation of Routine EM using Facility V ...
- Basic & Intermediate
- 90 Mins
- Joy L. McElroy
- Mar 28, 2019
The Pharmaceutical Quality System: An element of Contemporary Compliance
The term Quality System began appearing in FDA publications and guidance about the turn of the century. In 2008 the FDA and ICH released ICH Q10, The Pharmaceutical Quality System and many of the FDA publications are based on the Quality System philosophy. The ...
- Basic & Intermediate
- 90 Mins
- Jerry Lanese
- Mar 28, 2019