This seminar gives guidance on how to achieve compliance for Excel spreadsheets and other end user applications, such as small databases, in a GxP environment. While the examples given in this seminar are mainly spreadsheets, the same principles can be applied to other end user applications.
Spreadsheets are available for creating a wide range of end user applications, including customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as they are not originally designed for the regulated environment.
Prepare Your Company to Comply with the New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods
In this two-day workshop conference, you will learn the legal requirements, how to develop a company plan that meets FDA and your customer requirements. You will review and learn how to establish appropriate temperature monitoring, sanitation, container test and traceability, training and data reporting procedures.
New low-cost GPS enabled traceability and temperature monitoring technology, EPA approved container sanitizers, washout technologies, temperature maintenance equipment, and food residue and bio-contaminant testing will be presented.
The session will also review the future of transportation food safety in light of new and evolving technologies. References to upcoming technology providers and Internet links to detailed information will be provided.
Course "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
FDA's risk-based regulatory strategy
National Institute of Standards and Technology
Voluntary standards and programs
Premarket software validation and design requirements
Postmarket Software recalls
This 2-day seminar includes an overview of the need for clinical research, types of clinical trial designs, common statistical tests, considerations of sample size, and randomization techniques.
The role of statistics in clinical trials incorporates the tools used to develop a robust study, minimize bias, and assess efficacy of new treatments as relates to efficacy and comparison to competing therapies.
Prior to the use of experimental research, clinicians often used subjective measures and anecdotal evidence of treatment efficacy. Concepts such as variability among individuals and treatments were not considered in early applications.
This hands-on course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with Computer Systems Validation as follows:
What is 21 CFR 11/Annex 11 and Computer Systems Validation and how is it implemented
How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?
Data Integrity Frequently Asked Questions
Validation Master Plan
Risk Based Assessment
Complete Validation for a System (software development lifecycle)
Understand what is expected in Part 11 and Annex 11 inspections
Avoid 483 and Warning Letters
Learn how to buy COTS software and qualify vendors.
Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
Requirements for local, SaaS, and cloud hosting
How to select resources and manage validation projects
"Right size" change control methods that allows quick and safe system evolution
Minimize the validation documentation to reduce costs without increasing regulatory or business risk
Write test cases that trace to elements of risk management
Protect intellectual property and keep electronic records safe
Europe's new Medical Devices Regulation 2017/745 (MDR) takes effect in May-2020. That seems like plenty of time, but smart companies should start planning their CE transition strategy right away. With manufacturers all over the world transitioning to the MDR and ISO 13485:2016 in the next few years, Notified Body staff shortages and work backlogs are likely to cause delays.
This two-day seminar will provide you insights that allow you to identify the best transition strategy for your company based on your product range, certification cycle, markets you serve, and your Notified Body.
This course will begin by presenting a primer on statistical analysis, focusing on the methods required for analysis of designed experiments. It will then present the steps to DOE, while demonstrating valuable risk management tools (Ishikawa and FMEA) which can be use pre and post DOE studies. Next, participants will learn to generate and analyze multiple screening and response surface designs; the participants will leave with an understanding of why and how each are used. Then, the participants will learn how results of the studies can be presented. Lastly, using the results of the studies, the risk management tools will then be updated.
Course "Clinical Evaluation Report for Europe and MEDDEV Expectations: Impact with New Medical Device Regulations (MDR)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Clinical Evaluation Report and MEDDEV
Consulting Case Study Practice
Case Study Practice
Interactive Exercises and Discussions
Questions and Summary
Venue: Hilton Zurich Airport, Zurich, Switzerland
The webinar includes a brief overview of the Interagency Appraisal and Evaluation Guidelines and its requirements for appraisal reviewers and what agencies enforce USPAP.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/USPAP-Issues-Best-Practices-for-Residential-Appraisal-Reviewers-Avoiding-Violations-508477/JULY-2018-ES-TRAININGREGISTRY
Learn best practices to protect accounts payable payment process from potential fraud and risk management techniques for handling ACH, Check, and Credit Card Fraud.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/Accounts-Payable-Payment-Fraud-Risk-and-Risk-Mitigation-ACH-Check-and-Card-505141/JULY-2018-ES-TRAININGREGISTRY
Join this webinar to understand relevant inspection steps in relation to Root Cause, how to use RCA to better effect, what RCA tools really, more.
Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/Problem-Solving-Root-Cause-Analysis-in-Pharma-Manufacturing-503456/JULY-2018-ES-TRAININGREGISTRY
This webinar will discuss the best practices of analytical method validation, including components of a validation, how to include critical reagents comparison, selectivity experiments, assessment of stability, importance of communication between the development and the validation labs and accuracy of transfer documents.
This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).
This Project management training will provide you with a solid foundation for managing that first project or to simply sharpen existing project management skills, It is not just important to learn about project management - project management has its own body of knowledge, Also The webinar is designed to build a working understanding of the subject and for a quick start-up for those unanticipated project management assignments.
Attend this webinar to learn how to reduce the risk of penalties in your practice and tips for avoiding breaches and learn about real-life HIPAA compliance issues.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/Is-Your-Medical-Practice-HIPAA-Compliant-Requirements-for-Privacy-Security-and-Breach-Notification-508689/JUNE-2018-ES-TRAININGREGISTRY
Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.
This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls!This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control.
You'll learn about the essential elements of purchasing control and how you can translate them into your procedures. We'll discuss the process steps for purchasing control and how it relates to other parts of your QMS including receiving and acceptance activities.
This webinar focuses on DOE strategies, and explains use of DOEs during process validation, The effective and progressive use of a Screening DOE, a Mapping DOE and a Robust Process DOE will lead to a better understanding of the process and the location of the best optimum.
This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program.
The ISO 62366 is an "Consensus"Standard, making it a gold standard for regulatory submissions. We will look at other reference points regarding HF, like AAMI/ANSI HE75:2009 and how HF Engineering include consideration of:
Use Environments and User Interfaces
Exploratory HF/Usability Evaluations
Hazard Mitigation and Control