Training Courses, Classes, Seminars and Webinars

Our one day critical thinking workshop containing a framework and the core tools to learn and immediately put to use. Click on the link for more information March 5 - 2020 - Denver, CO

This course is a comprehensive training on pharmaceutical water systems encompassing over 15 different course subject and modules. The modules include design, build, installation, validation, regulatory compliance, regulatory audit expectations, documentation expectations, modules on continuous electrodeionization (CEDI), ozone, reverse osmosis (RO), distillation methods, pure steam generation, pretreatment options, microbial mitigation and sanitization methods, raw water and sourced water criteria, instrumentation for both observational and compendial criteria, and automation expectations. Microbial mitigation is one of the most important aspects for purification systems. This course emphasizes the mitigation of microbials in Purified Water and WFI water systems. Profiling microbials in pretreatment systems is a non-compendial exercise.

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. https://www.globalcompliancepanel.com/seminar/-901993SEMINAR?channel=trainingregistry-mar_2020_SEO

Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices. Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Simple linear regression and analysis-of-covariance (ANCOVA) are used for setting expiries and conducting stability analysis studies. Two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used for analyzing designed experiment for process development and validation studies.

Understanding the complexities of the Fair Labor Standards Act (FLSA) is critical to effectively identifying, assessing, and mitigating FLSA risk. Covering everything from minimum wage to misclassification, this intensive course lays out all of the FLSA’s key requirements to help HR professionals and employment counsel assess their overall wage and hour compliance profile and effectively audit and manage their FLSA risks. The course covers a broad range of FLSA issues, including compensable time and off-the-clock risks, overtime exemptions for executive, administrative and professional employees, calculating regular rates of pay, and worker classification.

This SharePoint 2013 End User class is for end users working in a SharePoint 2013 environment. The course teaches SharePoint basics such as working with lists and libraries as well as basic page customization.

This one-day course is for technical personnel involved in the sizing, selection and operation of Pumps in Oil and Gas Processing facilities. The course focuses on the hydraulic principles of centrifugal pumps, their sizing and system design. You will learn quick pump calculations for conceptual studies along with rules of thumb as well as rigorous calculation required during detailed engineering phase. This course is tailored for individuals who have some pump basic knowledge and/or are seeking a deeper understanding of how centrifugal pumps work, and when and how to apply this knowledge. This course benefits those who are involved in some facet of pump design or application. Technicians, Operators and Junior Engineers will find this course especially helpful and relevant.

This 1-day course addresses the challenges and barriers facing many individuals in the workplace regarding the giving of constructive feedback. Often a difficult and awkward topic of conversation, this session will explain the rational for providing constructive feedback, along with skills and techniques for having difficult yet productive conversations with colleagues. Feedback scenarios, small and large group discussions, and learning activities will provide participants with opportunities for peer-to-peer practicing for giving constructive feedback.

The purpose of this seminar is to increase the skill and knowledge of Engineers, managers and operators in Technical Safety BC, and Safety Code requirements in British Columbia Oil and Gas industries. Seminar Objectives The overall objective of this seminar is to give students a background in: 1. Technical Safety BC requirement for Design, Fabrication, Construction, Welding, Inspection, In-service Inspection of Pressure Equipment. 2. Interfaces between Technical Safety BC and OGC (British Columbia Oil and Gas Commission)

The purpose of this seminar is to increase the skill and knowledge of Engineers, Managers and Operators in ABSA (Alberta Boilers Safety Association), and Safety Code requirements in Alberta Oil and Gas industries. Seminar Objectives The overall objective of this seminar is to give students a background in: 1. ABSA requirements for Design, Fabrication, Construction, Welding, Inspection, In-service Inspection of Pressure Equipment. 2. Interfaces between ABSA and AER (Alberta Energy Regulator) A complete set of course materials is included in the ABSA Requirements From Design to Operation course.

This highly interactive one-day course is designed for leaders, team members, and anyone who needs to assess risk and make decisions. Too often these two activities are based on subjective bias and not objective facts. This course will discuss the bias that we all have and present methods to assess risk and make decisions as a team with minimal bias to obtain the best possible results. The methods of facilitated risk assessment using risk matrices and fault tree analysis will be explained and both methods practiced in the classroom. A structured and quantified method of making decisions will be taught and practiced based on the Kepner Tregoe Method.

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.

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: Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities. Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing. Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.