Global Compliance Panel (GCP) Past Events
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project`s objectives. Participants will be walked through the scheduling process from start to finish in language that will clearly describe those scheduling tasks that must be accomplished to build a solid project schedule from the point of creating the WBS to the actual execution of the project and monitoring and controlling project performance. Scheduling compression and optimization techniques will be discussed and applied to the examples used to explain the scheduling process.
Scientific Writing Fundamentals - Mastering the Basics in Life Sciences Documentation is a dynamic and comprehensive 90-minute webinar designed to empower researchers, students, and professionals in the life sciences field with essential skills for effective written communication.
This workshop is about understanding what is behind the Monte Carlo Simulation. First, you will find out who is using simulations and for what purposes (risk analysis, operations, investments.) The next part is about having fun applying simulations - rolling dice on a spreadsheet. Once you understand how it is done we can go into a couple of projects. One project is when we simulate a four years budget for 200 times (800 years.) The workshop will have other examples of Monte Carlo simulations.
Course "Applied Statistics for FDA Process Validation" has been pre-approved by RAPSas eligible for up to 12credits towards a participant`s RAC recertification upon full completion. In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the `process design stage through commercial production` into three distinct stages of the product lifecycle:
FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA`s thinking, negotiate with the FDA and offer anecdotal examples of FDA`s import program curiosities.
Course "Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC" has been pre-approved byRAPSas eligible for up to12credits towards a participant`s RAC recertification upon full completion.
There are two phases to this topic. The first is auditing itself. Good audits are well structured. They must consider the reasons for the audit, the regulatory requirements, as well as the nature of the laboratory being audited. We will discuss the considerations that must be made when auditing a laboratory. The social interactions that must be expected, the nature of the regulatory requirements and the nature of work that the laboratory performs will be discussed.
