Training Courses, Classes, Seminars and Webinars

This seminar is based on the current state of regulations and will cover the essential parts of the data management plan, study startup, study conduct, study closeout and study monitoring. A data management plan or DMP is a formal document that outlines how data are to be handled both during a research project, and after the project is completed. The goal of a data management plan is to consider the many aspects of data management, metadata generation, data preservation, and analysis before the project begins; this ensures that data are well-managed in the present, and prepared for preservation in the future. Attendees will be able to: Define best practices as they apply to CDM processes Describe CDM processes from study start-up to database lock Apply best practice rationale when assessing data collection requirements/instruments Evaluate the benefits of standardization in establishing CDM processes Discuss current technology/methods of data collection and associated documentation

The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary recommendations

This two-day, experiential seminar presents attendees with the most up-to-date neuroscience findings on mindfulness practice, including which techniques have been shown to change specific areas of the brain for better mental health. Brain-changing mindfulness exercises that can help depression, anxiety, trauma, and addiction symptoms will be discussed. Additionally, most of these techniques will be practiced during the seminar, and attendees will be provided with detailed instructions and scripts for all techniques taught, so that they may begin to incorporate these techniques into their practice immediately. Neuroscience research Neuroscience of mindfulness Clinical applications of mindfulness Mindfulness practices Treatment compliance

Attendees will leave the course clearly understanding the role and all the requirements as the designated as a HIPAA Security and Privacy Official. This one day comprehensive seminar will cover reviews, creation, and amending policy and procedure. After completing this course, a HIPAA Security and Privacy Official will have a clear understanding for what needs to be place when it comes to all of the HIPAA regulations. What is HIPAA, HITECH & the Omnibus Rule The Role of the HIPAA Privacy & Security Officials How Officials Can Mitigate Risk HIPAA Privacy Rule Requirements Reviewing Notice of Privacy Practices (NPP) Authorized and Permitted Disclosures How to Preform a HIPAA Privacy Assessment HIPAA Security Rule Requirements Administrative, Technical, and Physical Safeguards Managing the Business Associates Process How to Perform a HIPAA Risk Assessment What HIPAA Policies and Procedures Must be Covered HIPAA Risk Management Plans HIPAA Enforcement Trends - Lessons Learned

Areas Covered in the Session: What is HIPAA, who is covered and what is HIPAA Compliance Why the healthcare organization should be concerned about HIPAA compliance How to perform a HIPAA Risk Assessment How to prepare HIPAA Policies and Procedures How to perform HIPAA Training What is IT's role in the healthcare organization's HIPAA Compliance How to prepare a Business Continuation/Disaster Recovery Plan How to handle a potential HIPAA Breach

This seminar addresses the integrity of GxP records and data used within the regulated industries including pharmaceutical, biological, medical devices, cosmetics, food and any other industry where data integrity is important. It provides a method for managing risk to record and data integrity. Learning objectives for the seminar include: data integrity Requirements Critical Areas of Regulatory Focus and Concern Key Concepts A Framework for data integrity and Human Factors A Complete Data Life Cycle Approach as Part of a Quality Management System, from Creation to Destruction How to Apply Risk Management to data integrity

Upon completing this course participants should be able to: Evaluate linear quantitative measurement procedures and sources of error. Distinguish the difference between confidence and tolerance intervals Evaluate the appropriateness of the effect of sample size in given procedures. Evaluate laboratory/clinical quality control based on risk management Interpret statistical process control Distinguish between FDA requirements and ICH guidelines

This two-day seminar will cover the essentials of an effective yet efficient Quality management system for medical device companies. An efficient and effective Quality System can be a competitive advantage for companies by leading to improved Quality and compliance as well as optimizing the cost of Quality. This seminar will get you started in setting up just such a Quality System. We'll discuss the "case for Quality" and how you can use compliance, not as an end itself, but as a means to improved Quality and reduced cost of non-compliance. In this Seminar, we will discuss: Regulatory Expectations How to plan, structure, and implement a Quality System Common problems and lessons from 483 and Warning Letters Red-flags that your QS is not effective Six essential capabilities for an effective and efficient QMS Risk analysis and management techniques Process control and performance monitoring Culture, Management Responsibility, and maturity Strategies for improvement

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. Topics: FDA's risk-based regulatory strategy Cybersecurity Interoperability National Institute of Standards and Technology Voluntary standards and programs Mobile Apps Premarket software validation and design requirements Postmarket Software recalls

This one-day seminar will be addressing how medical practice managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, as there is so much misleading information regarding the do's and don'ts with HIPAA - I want to add clarity for specific to medical practice managers.

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) Equipment Qualification Infrastructure Requirements Change Control SOPs

Course Objectives: 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. http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901633SEMINAR?trainingregistry

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 https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901861SEMINAR?trainingregistry

This one-day seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, as there is so much misleading information regarding the do's and don'ts with HIPAA. I want to add clarity for compliance officers.

This course will also show you how to perform ongoing assessments of learners' retention of knowledge of SOP content for continuous improvement and avoidance of procedural deviations, using the tools already available in your company's training software.