Protocol Web-based Seminars

MOC 2277 - Implementing, Managing, and Maintaining a Microsoft Windows Server 2003 Network Infrastructure: Network Services This Windows Server 2003 training class provides students with the knowledge and skills to implement, manage, and maintain a Microsoft Windows Server 2003 network infrastructure. The class is intended for systems administrator and systems engineer candidates who are responsible for implementing, managing, and maintaining server networking technologies. These tasks include implementing routing;  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePan ...with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result from willful or knowing  more...

Breakthrough Performance Management that is Practical Effective and User-Friendly ...s necessary to achieve them. Using a simple but effective protocol and checkpoints along the way, the manager is assured that the employee is progressing as planned and the employees always knows whether they are on-track to produce the right kind of results. Use performance conversations instead of the negative performance confrontations that occur at annual appraisals is a 21st century way of  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ...and Differences-Supplier and Component Consistency * Protocol Approval Process for Installation & Operational Qualification and Process Validation * Executing the Protocols * Reviewing the Issue Protocols, Taking Appropriate Actions, and Writing the Report * Revalidation Who Will Benefit: * Quality, quality control, regulatory, engineering, and manufacturing and IT  more...

Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel Overview: The Cloud Computing / Software as a Service (SaaS) Webinar will present the best practices for the validation of a SaaS Customer Relationship Management (CRM) Solution. Our presentation will offer an introduction to cloud computing and explain the benefits of using a SaaS system. We will detail the differences between a Conventional Implementation and a SaaS Implementation  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ...e is to follow exactly the signed and approved (IRB + PI) Protocol to the letter. This, in fact, is included on the FDA Form 1572. In the current regulatory climate, GCP Investigator site audits are a part of the clinical trail process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...ply with FDA and international regulations for validation protocols. Attendees will also learn how to maintain adequate validation documentation systems and perform equipment qualifications and process validations, and evaluate the need for re-validations. Why you should attend: The guideline on "General Principals of Process Validation" was issued in May, 1987, and since then, medical  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel ...ing out this clinical study * Prepare outline of the protocol * If the study is carried out in EU obtain the EUDRACT number in accordance with the Clinical Trial Directive requirements * Start to prepare the outline plan for the study using the work breakdown structure (WBS) technique, outline Gantt chart with estimated timelines for main activities of the study * Identify  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...tended use + Establishing the validation protocol o The guidance document + How much validation evidence is needed? + Defined user requirements + Validation of off-the-shelf software and automated equipment * Electronic records o General requirements for records o Definitions from Part 11  more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel ...cesses. PV requires writing and executing a validation protocol that explores either natural variation or introduced variation in a process and shows that the process can consistently produce a quality product. Writing and executing good process validation can be a daunting task given the complexities of today's biotech and pharmaceutical processes. Guidance's are helpful in writing process  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane ...with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result from willful or knowing  more...

Navigating Pediatric Trials from recruitment to successful on-time completion - Webinar by GlobalCompliancePanel ...d difficulties in developing the right study criteria and protocol. When conducting research on children, drug companies must ensure that ethical boundaries are observed in both the design and execution of pediatric trials. Attend this Webinar to understand the ethical, economic, regulatory and technical considerations when conducting clinical studies on children. Discussions evaluate the  more...

Defining and Managing Protocol DeviationViolationException - Webinar by GlobalCompliancePanel ... trial be followed exactly. If there are Instances of "Protocol Not Followed" (PNF), that could result in a failure to determine safety and effectiveness. That is why eligibility criteria are so strict, and why any PNF or unexpected events need to be reported immediately. Principal investigators in clinical trials are expected to adhere to the study protocol. Instances of a Protocol Not  more...