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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

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

Course "Fundamentals of Statistical Process Control: Implementation and Assurance of SPC" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This 2-day seminar provides the information you need to use one of the most powerful tools in quality, statistical process control. It will help people in design, quality, and production understand the concepts and effectively implement them. The examples and issues in the seminar come primarily from the medical device industry, but the material is applicable to any production environment. Production process must be controlled to help ensure they are stable. While there are many control methods, the most powerful and often used is statistical process control, SPC. It uses data from the process itself to detect changes - changes that could result from an unstable process. SPC helps determine if a process continues to operate the way it was set up. If not, SPC produces a signal that calls attention to the problem. One very important application is process capability analysis. With a stable process, SPC data can help determine if the process is capable of meeting the product specifications. These are often expressed as process capability indices. Continuous improvement programs can use the information generated by SPC to monitor process variation and identify its causes. These methods can reduce cost, improve product, and enhance customer satisfaction. Why should you attend: Manufacturing companies, especially medical device manufacturers, must control process. Not only is this a regulatory requirement, but is a good business practice. Without a solid understanding of SPC, you put yourself and your company at a disadvantage. On a personal basis, the material in this seminar will help improve your skills; it aligns with the ASQ Body of Knowledge for the Certified Quality Engineer, Green Belt, and Black Belt. These are areas you should master

Amidst the corona pandemic, CMS offered flexibilities to assist QPP MIPS 2020 eligible clinicians. Learn about the changes to submit data to CMS successfully.

Amidst the corona pandemic, CMS offered flexibilities to assist QPP MIPS 2020 eligible clinicians. Learn about the changes to submit data to CMS successfully.

With MIPS 2020 just around the corner, eligible clinicians are ready to submit quality data to CMS in order to improve their financial situation. We all are rooting for quality healthcare services, and technology incorporation is an efficient way to achieve this goal. For the same reason, MIPS eligible clinicians from all specialties are adopting

CMS expects eligible clinicians to perform well in MIPS QPP. Sometimes despite the efforts, physicians are unable to meet even the minimum performance threshold. We can't blame them if they happen to suffer from unexpected hardships such as severe weather conditions or other unfavorable situations.

CMS expects eligible clinicians to perform well in MIPS QPP. Sometimes despite the efforts, physicians are unable to meet even the minimum performance threshold. We can't blame them if they happen to suffer from unexpected hardships such as severe weather conditions or other unfavorable situations. CMS offers relaxation for such cases.

Corona has overburdened the healthcare system, and CMS has announced some relaxations for eligible physicians to facilitate them. Read how CMS has eased the MIPS 2020 data submission process.

Different types of medical practitioners qualify for MIPS 2021 reporting. They can do it as individuals, as part of a group, or even as a virtual group. Though, there are some exclusion cases from participation.

CMS extends the deadline for MIPS 2020 targeted review to help eligible clinicians check their data, score, payment adjustments, and apply for reweighting in case of any effect.

Discover how Instapay Healthcare Services provides comprehensive ortho revenue cycle management solutions for orthopedic practices. From eligibility verification to claims management and financial reporting, Instapay streamlines the revenue cycle, ensuring efficient and timely reimbursement. With their specialized expertise, ortho clinics can focus on delivering exceptional patient care while maximizing profitability.

At Instapay Healthcare Services, we offer a wide range of services that cover all aspects of the revenue cycle management process, from eligibility verification to denial management.

Hip Hop 4 Healthcare is an association that introduces the Patient Protection and Affordable Care Act through hip hop culture. Our goal is to enroll all eligible Americans in affordable healthcare. We offer different types of health insurance plans that suits your budget and your health needs.

Government introduces healthcare services across the United States to make sure all the eligible Americans can get qualified health insurance plans to avoid a tax penalty.

We bring our clients the proven expertise of a large network of trained and qualified coders with substantial exposure to the coding requirements across all specialties, and working experience with small clinics, multispecialty providers, and hospitals.

We bring our clients the proven expertise of a large network of trained and qualified coders with substantial exposure to the coding requirements across all specialties, and working experience with small clinics, multispecialty providers, and hospitals.

MIPS put forwards the opportunity to get incentives and bonuses aside from the regular payment model. The revenue cycle runs smoothly, and also if a clinician performs well in all MIPS performance categories, he/she can earn a reputation in the healthcare industry among fellow physicians.

MIPS 2019 performance year is about to end. Only a little time is left until eligible clinicians can report for MIPS healthcare. MIPS put forwards the opportunity to get incentives and bonuses aside from the regular payment model.

Here you'll find the official resources to report MIPS 2020; P3Care has a habit of coming up with useful information about the MIPS program. As a CMS MIPS Qualified Registry, in an effort to find the most relevant content for physicians, consider it as another episode.

Small Medical Practices! P3Care has been doing well as MIPS Qualified Registry for four years now. During this time, we come up with many little tricks to achieve a minimum performance threshold to be safe from the penalty. Read the article below to know how small practices can avoid the negative payment adjustment in MIPS 2019 reporting.

Physical therapists are included as one of the groups of healthcare practitioners eligible for MIPS reporting in 2019. It was time their duties were rewarded with an open heart and a clear head. Physical therapy is a serious branch of medicine that, now, comes in the quality circle of the government where physical therapists (PTs) can receive incentives based on their performances.

According to CMS, the year holds comparatively doable reporting requirements as well in an effort to reduce physician burnout. By the introduction of the "Opt-In" policy, clinicians can now participate in the program and win rewards as if they were eligible for it.

The argument that CMS needs to improve MIPS is a thing in the past. Now, the focus is on "how to devise ways that actually implement the change and stands true to its promise of a better healthcare system.