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Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: 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: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend : * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors /

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: 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: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend: * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors / Senior

Seminar on Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant at Boston, MA Course "Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: In this two day workshop conference you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies will explore how your management practices of your analytical equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors. This seminar will help attendees understand the instrument qualification and system validation processes and will provide instruction on how to prepare for FDA audits and how to become part 11 compliant. Why should you attend? The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility? Areas Covered in the Session: * Learn about the regulatory background and requirements for laboratory instrument qualification and system validation * Understand the logic and principles of instrument qualification and system validation from validation planning reporting * Understand and be able to explain your company's qualification and validation strategies * Be able to independently prepare execute test protocols, this includes s

Overview: Upon completing this course participants will leave with a preliminary preventive control implementation plan and will: * Understand US FDA final rules for the Preventive Controls for Human and Animal Foods * Define and review your current system to identify gaps in your preventive controls planning. * Be able to develop and implement a valid preventive control company food safety plan to close any gaps * Write and implement appropriate procedures. * Know your requirements for control over your supply chain * Be able to plan and implement HARPC * Be able to perform environmental monitoring * Know how cross contamination can impact your preventive control plan * Know the difference between validation and verification * Understand and be able to use statistical process controls basics * Be able to plan and implement a team approach to preventive controls * Be able to help your food importers to jump through FDA hoops * Develop a system to risk rank your suppliers * Have a plan in hand that will pass any validation check for preventive controls * Understand some of the technology and costs that can help you establish preventive controls * Prove that your system actually prevents food safety problems * Be able to document and report results to upper management, external food safety auditors and FDA auditors * Save your company money Establish simple, low cost complete data collection and reporting systems. * Establish teambuilding between food safety and quality personnel to develop and implement changes to your current system * Understand food safety, security and recall responsibilities in light of cargo theft, adulteration and temperature failures * Learn how to use your system to get some ROI and improve your marketing position * Review current and future technologies designed to improve and simplify data collection * Establish a completely documented system Why should you attend: Validation of preventive co

Course "Verification vs. Validation - Product Process Software and QMS" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. Why you should attend: This session helps participants: * Understand Verification and Validation, differences and how they work together; * Discuss recent regulatory expectations; * Know how to document a "risk-based" rationale, and use it in a resource-constrained environment; * Determine key "milestones" and "tasks" in a project; * Locate and document key subject "inputs"; * Compile "generic" Master and Individual Validation Plans; * Learn the key element of a Product V&V File/Protocol; * Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols; * Get a grasp of basic Test Case construction; * Understand sample sizes and their justification; * Learn the key elements of Software V&V expected by the FDA and how to document; * Deal with hardwa

2-day In-person Seminar Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing Overview: The 2-day seminar explains how to apply statistics to manage risk 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. 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, from a risk management perspective Agenda Day One Lecture 1: Regulatory Requirements Lecture 2: Vocabulary and Concepts Lecture 3: Confidence Intervals (attribute and variables data) Lecture 4: Normality Tests and Normality Transformations Lecture 5: Statistical Process Control (with focus on XbarR charts) Lecture 6: Confidence/Reliability calculations for Proportions Lecture 7: Confidence/Reliability calculations for Normally distributed data (K-tables) Lecture 8: Process Capability Indices calculations(Cp, Cpk, Pp, Ppk) Day Two Lecture 1: Confidence/Reliability calculations using Reliability Plotting (e.g., for non-normal data and/or censored studies) Lecture 2: Confidence/Reliability calculations for MTTF and MTBF (this typically applies only to electronic equipment) Lecture 3: Statistical Significance: t-Tests and related "power" estimations Lecture 4: Statistical Significance: ANOVA calculations Lecture 5: Metrology (Gage R&R, Correlation, Linearity, Bias , and Uncertainty Budgets) Lecture 6: QC Sampling Plans (C=0 and Z1.4 attribute AQL plans, and alternatives to such plans) Lecture 7: Statistically valid statements for use in reports Lecture 8: Summary and Impleme

Course "Risk Analysis and Design of Experiments (DOE) in Process Validation and Development" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to help scientists and engineers plan and conduct experiments and analyze the data to develop predictive models used to optimize processes and products and solve complex problems. DOE is an extremely efficient method to understand which variables (and interactions) affect key outcomes and allows the development of mathematical models used to optimize process and product performance. The models also provide an understanding of the impact of variability in controllable and uncontrollable factors on important responses. The concepts behind DOE are covered along with some effective types of screening experiments. Case studies will also be presented to illustrate the use of the methods. This highly interactive course will allow participants the opportunity to practice applying DOE techniques with various data sets. The objective is to provide participants with the key tools and knowledge to be able to apply the methods effectively in their process and product development efforts. Why should you attend: · Plan and conduct experiments in an effective and efficient manner · Apply good experimental practices when conducting studies · Determine statistical significance of main and interaction effects · Interpret significant main and interaction effects · Develop predictive models to explain and optimize process/product behavior · Check models for validity · Utilize models for one or more responses to find optimal solutions · Apply very efficient fractional factorial designs in screening experiments · Apply response surface designs for

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. Why should you attend: Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supp

Course "Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP) Both FDA Quality System Regulation (QSR) and ISO 13485 require that companies do internal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effectiveness of their internal audit system from the FDA during FDA Inspections. ISO 13485 auditors do look at internal audits, but are most concerned that you define a process that meets the requirements of the standard and are following your process. Both require that you define Auditor training is required, but this sometimes just requires reading the company's procedure, although most external auditors will look for more than this. Do you need to train new auditors for yours medical device quality management system or to audit your suppliers? Or do you need to improve the training of your internal and supplier auditors so that they add value to these audits? If you need to do either of these, this seminar will provide this training. In addition to auditing skills and hands-on auditing exercises, this seminar will provide an ove

Overview: The presentation takes the participant through the steps needed to ensure a successful health care computer system implementation. Once presented the participant will see the logic of the tools and processes and be able to apply them to their system implementation. The tools and processes presented in this material have been developed by implementing health care systems for over 40 years and seeing what has worked and WHY it has worked. These tools and processes have been equally and successfully applied to the implementation of large, complex systems and smaller, simpler systems for large, multidepartment organizations and for small health care organizations. The process focuses on establishing the project's implementation expectations, identifying meaningful metrics for success, establishing project plans, assigning individual accountabilities and responsibilities, establishing and executing project tasks, monitoring project progress and validating project success. To establish viable project expectations, the presentation addresses the need for bringing all of the stakeholders (organization owners, providers and management, operations staff, IT staff and the vendor) into establishing common and realizable expectations. These are reviewed in context of the organization's current environment and its short and long term goals and are considered as a critical part of the implementation completion process. In the case of turning around an already troubled or failed system implementation, the process emphasizes the tasks of reassessing the project stakeholder expectations - why they decided the system would help the organization and what they expected to get from the system. Next the process shows the participant how to convert these expectations to realistic and measurable project success metrics. The process focuses on learning how to separate "so what" metrics from meaningful and measurable metrics. In addition, the process provides direction regardin

Overview:   Institute for Healthcare Improvement (IHI) defines reliability as "failure-free performance over time2". This is simple enough to be understood by anyone. The aim is to have no failures over an extended time period in spite of variability in the patient environment. spite of variability in the patient environment.  This is in line with the technical definition of reliability as the probability of successful performance of intended functions for a specified length of time under a specified user (patient) environment. In a system where the severity of consequences is high, such as in hospitals, the goal is to achieve reliability as close to 100% as possible. This is called failure-free performance. Some hospitals have achieved this goal for specific medical procedures for several quarters. Can they extend this performance over years instead of quarters? That is the challenge we need to face and find elegant solutions zero mistakes or find a way to protect patients if a mistake cannot be prevented.  Why should you Attend: The failures of the U.S. healthcare system are enormous considering the severity of failures. As much as 400,000 patients die each year from hospital mistakes. Another 2.1 are harmed from nosocomial infections (infections acquired during hospital stay). The cost is in billions. Discussions with doctors show that there is reluctance to apply reliability principles to healthcare systems because the variability in healthcare is enormous compared to the aviation and industrial fields. Each customer (patient) is different and each illness is unique in its own way. Then there are interconnecting systems such as cardiology, gynecology, gastroenterology, emergency medicine, oncology, and patient data from various doctors, pagers, computers, vendor software, and intensive care, each operating independently most of the time. But good approaches to improving the system reliability have been tried and tested in many industries. There is a

Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? State laws are enacted for the protection of the public by legislatures in all the fifty states. A list of individual professions and their applicable statues and administrative regulations takes up entire volumes of lawbooks. These state laws impose significant regulation on these professionals, and often in very different ways found in many aspects of state regulation, from the educational process, the examination requirements, the state licensure applications, and the legal standards and rules of each unique profession. Explore how state licensure boards are created and function at the state level. While most such state agencies have common, core functions and operations, there are many differences - and some requirements that are truly the opposite from profession to profession. Review the common requirements the state imposes on the health care provider. Know the basics of professional education and licensure. Understand the difference between legally binding laws and mere codes of ethics, which are aspirational and do not form the basis for legal action. Find out how to understand and navigate the challenges presented from differing and conflicting state laws governing the many health care professions. Know where key requirements exist that are common to many professions. This program offers an obje

Course "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from

Course "Internal Auditing for the Medical Device Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course provides an overview of internal auditing requirements and techniques for medical device companies as a method for risk management and quality improvement. The course will cover auditing requirements, audit planning, preparation, knowledge, auditor skills, interviews, documents and records review, objective evidence, audit report writing and corrective action. Why should you attend: Attendees should attend this seminar for risk management and improvement purposes to identify weaknesses, problems, compliance risks, and improvement opportunities. Who Will Benefit: * Quality Manager * Quality Associate * Quality Engineer * Quality Technician * Regulatory Associate Agenda: Day One Lecture 1: Overview of an auditing program, principles of quality management systems and how they related to auditing, benefits of auditing, and what is auditing. Lecture 2: Types of audits, auditor qualifications, ethics, responsibilities, audit phases, audit planning, and scheduling. Lecture 3: Conducting audits, interview techniques, objective evidence, data collection, tracing, use of checklists, and reviewing documents and records. Lecture 4: Conducting process audits, running closing meetings, audit report writing, corrective actions, and improvement Day Two Lecture 1: Overview to auditing to ISO 13485 and FDA QSR. Global differences which affect auditing approaches, auditing document control and record keeping, management responsibility, and resource management. Lecture 2: Auditing order handling, design control, purchasing, and supplier controls. Lecture 3: Auditing production, validation, and preservation. inspection and testing, control of test equipment, customer property, and sterilization Lecture 4: Auditing customer feedback, internal auditing programs, complaint

Breast cancer is the type of cancer that has a valid preventive strategy if we're talking about active prevention. There are about 1.38 million new cases and 458 000 deaths from breast cancer each year. Early diagnosis is a cornerstone for breast cancer care.

Instapay Healthcare Services is a good example of how AI can be used to check medical credentials. Their platform offers advanced verification and validation, faster processing of applications, and updates and alerts in real time. These features make it easier for healthcare organisations and providers to sign up providers and improve the overall experience for both groups.