FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

The FDA has set out requirements for validating all computer systems that handle data regulated by it. These should be in accordance with its guidance on computerized systems, first issued in 1983. The main points of this guidance continue to be consistent today, even with all the changes that technological developments have brought in.

The 1990’s was a decade in which this guidance was revisited for its relevance to the medical device industry. This was because the first issuance was limited to pharmaceuticals.  In 1997, in the context of the move of many FDA-regulated organizations to move into a paperless environment, the FDA issued 21 CFR Part 11, which sought to address electronic records and signatures.

A few changes, such as discretionary enforcement measures, have been brought into this guidance from then, to fashion it to the needs of the industry. Yet, this issuance is rather confusing, although it was intended to help the industry avoid creating a huge regulatory compliance cost, which was the main reason for which many companies were reluctant to adapt the technology.

What are the current trends in compliance and FDA enforcement?  Technology is a major basis for these trends, although there are other that are based on economics, social media, new diseases, politics, and many other influences.

All these will be discussed in detail at a six-hour learning session from GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance.  Carolyn Troiano, a senior compliance professional who has worked in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, will be the expert at this webinar, which is being organized on October 28.

Please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-fda-trends-for-computer-system-validation-(csv)-compliance-and-enforcement-10310LIVE to enroll for this valuable learning.

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Everything that is required to protect the validity of data that is regulated by the FDA and is stored in electronic format in computer systems will be explained at this webinar. The expert will describe the ways by which to properly validate an FDA-regulated computer system so that security is ensured and data integrity objectives are met.

It is accepted that implementation and adaptation of the System Development Life Cycle (SDLC) methodology is the ideal approach for Computer System Validation (CSV) and for maintaining the system in a validated state throughout its life. Carolyn will explain this aspect in detail at this webinar.

She will also discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation.

The following areas will be explained at this webinar:

Session 1 (90 Mins):

• FDA Regulatory Oversight
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology

Session 2 (90 Mins):

• GAMP 5 Software Categorization
• System Risk Assessment

Session 3 (90 Mins):

• Requirements
• Design
• Testing
• Requirements Traceability Matrix (RTM)
• Additional Validation Documentation

Session 4 (90 Mins):

• FDA Inspection Trends
• Regulatory Influences
• Response to Change

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About the speaker: During the over 35 years she has served in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, Carolyn Troiano has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.

She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and also collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Medical Device Recalls – How to Handle in a Compliant, Diligent Manner

A Medical Device Recall (MDR) can be a handful to deal with. It not only indicates that the device has a quality issue; failing to address an MDR rightly can lead to loss of reputation, not to speak of regulatory penal actions from the FDA. It is up to the company whose device has been recalled, to take prompt, prescribed action. Its actions should be proportionate to the level of risk the faulty device poses.

An MDR should be planned well in advance, for it is not something that a medical device can handle hastily, in a piecemeal fashion. The ways by which to prepare for an MDR is thus a matter of crucial importance. GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, will offer this valuable learning at a six-hour webinar it is organizing on October 28.

Susanne Manz, an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, will be the speaker at this session. To enroll for this webinar, please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-medical-device-recalls—how-to-handle-in-a-compliant,-diligent-manner-10304LIVE

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Even a high degree of preparation by a medical device company cannot completely rule out quality issues that result in a recall. There is no substitute for preparation. The objective of this webinar is to offer learning to its participants on how to prepare for an MDR. Susanne will explain how to decipher signals that could trigger a recall. She will also explain how to face the investigation and what actions are required, what corrective and preventive actions need to be taken, and how to send out notifications to customers and the regulatory bodies.

The expert will give a thorough understanding of the regulatory requirements for dealing with an MDR. She will help understand FDA expectations and regulations, and what to understand and learn from 483s and Warning Letters. The ways of putting robust processes, the basis to efficiently and effectively managing failure investigations, will be explained.

This webinar will also give a proper understanding of recalls, and explain the appropriate corrective and preventive actions that need to be taken. The ways in which these processes link to other aspects of the Quality Management System will be explained. It will give an idea of the best practices for making an MDR efficient. This will help participants prepare for a possible post-recall FDA inspection.

This webinar will have the following agenda:

• Regulatory Expectations
• Medical device authority and guidance
• Complaint Handling, Medical Device Reporting, and Recall requirements
• Recall Types and Classifications
• Failure Investigation
• Difference between a product enhancement and a recall
• Roles and responsibilities
• Non-conforming material control
• Recall strategy and FDA notification
• Required Communications
• Firm’s MDR reporting and FDA’s handling of MDRs
• Lessons learned and enforcement case studies
• Processes and Procedures
• Linkages between Complaint Handling, MDRs, Recalls, and CAPA
• Corrective and Preventive Action
• Minimize your risk of regulatory actions
• FDA’s new guidance on risk
• Preparing for an FDA Inspection

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About the expert: Black Belt, Master Black Belt, Regulatory Affairs Certification (RAC) and Certified Quality Auditor (CQA) Susanne Manz brings an extensive background in quality and compliance for medical devices, which spans all areas from new product development, to operations, to post-market activities. Her consulting business provides services to help medical device companies achieve world-class quality and compliance.

Become Better With Biostatistics for the Non-Statistician In 10 Minutes

That statistics can be a vital decision-making tool for clinical research is well-established. It is helpful for the clinician in situations where a p-value can help determine the next steps in the development of a drug or procedure. It is thus vital for decision makers to comprehend the theory and application of statistics.

We have many statistical software applications that help in arriving at crucial decisions. However, almost all these software applications were developed for statisticians. These software applications could confound the non-statisticians. Their confusion could start with something as basic as even knowing which key to press.

In this scenario, learning how to use biostatistics and derive its benefits is important. A marathon, six-hour webinar being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, on October 25, will explain biostatistics for the non-statistician.

Elaine Eisenbeisz, a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California, will be the expert at this webinar. Please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-biostatistics-for-the-non-statistician-10307LIVE to register for this webinar.

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This webinar, designed for non-statisticians, provides a non-mathematical introduction to biostatistics. Elaine will arm the participants with all the information and skills necessary for understanding statistical concepts and findings as they apply to clinical research, and to confidently convey this knowledge to people with whom they work.

This webinar will emphasize statistical concepts, application, and interpretation, and not on mathematical formulas or actual data analysis. Participants are expected to have an elementary understanding of statistics, but this is not mandatory.

It is aimed at professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

This will be the agenda that will be covered at this webinar:

Why Statistics?

• Do we really need statistical tests?
• Sample vs. Population
• I’m a statistician not a magician! What statistics can and can’t do
• Descriptive statistics and measures of variability

The many ways of interpretation

• Confidence intervals
• p-values
• effect sizes
• Clinical vs. meaningful significance

Common Statistical Tests

• Comparative tests
• Regression analysis
• Non-parametric techniques

Bayesian Logic

• A different way of thinking
• Bayesian methods and statistical significance
• Bayesian applications to diagnostics testing
• Bayesian applications to genetics

Interpreting Statistics – Team Exercise

• Team Exercise: Review a scientific paper and learn how to
  • Interpret statistical jargon
  • Look for reproducibility, transparency, bias, and limitations
  • Convey information coherently to non-statisticians

Study power and sample size

• Review of p-value, significance level, effect size
• Formulas, software, and other resources for computing a sample size

Developing a Statistical Analysis Plan

• Using FDA guidance as a foundation, learn the steps and criteria needed to develop a statistical analysis plan (SAP).
• An SAP template will be given to all attendees.

Specialized topics/Closing Comments/Q&A

• Comparing Survival Curves
• Pharmacokinetics/Pharmacodynamics (PK/PD)
• Taking a holistic view to study design and interpretation
• Question and Answer session.

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About the Director:

Elaine brings over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations to start-up companies and individual researchers. She has designed the methodology for numerous studies in the clinical, biotech, and health care fields.

She currently is an investigator on approximately 10 proton therapy clinical trials for Proton Collaborative Group, based in Illinois. She also designs and analyzes studies as a contract statistician for nutraceutical and fitness studies with QPS, a CRO based in Delaware.

Cracking the Code to Healthcare Billing, Coding and Reimbursement

Medical billing, coding, and reimbursement are the triumvirate that constitute the heart of a healthcare financial system. These three systems work in tandem with each other; yet, one miss in the cog in the wheel results in utter chaos. The whole system can go into disarray.

A marathon, four-hour session that is being organized on October 17 by GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, will explain all these elements in detail, so that confusions regarding the same can be eliminated.

At this session, which meets AAPC guidelines for 6.0 Core A continuing education units, Rich Hendriksen, Chief Executive Officer and founder of Nokomis Health, will be the expert. Kindly log on to https://www.globalcompliancepanel.com/virtual-seminar/4-hour-virtual-seminar-on-medical-claims-boot-camp—cracking-the-code-to-healthcare-billing,-coding-and-reimbursement-10309LIVE to register for this valuable session.

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At this course, the expert will explain the fundamentals of medical billing, coding, and reimbursement. He will show how all of these components work with each other. He will demonstrate how to practically apply all the latest industry knowledge and standards. As a result of this learning, those who work with medical claims and claims data stay ahead of the game. They will learn the following:

• The claim flow process from registration through adjudication and payment
• How physicians and hospitals set and manage charges
• Critical data elements on the two major claim forms and what they mean
• How and why the major coding systems are utilized
• How various reimbursement methods are used by payors.

The expert will organize the learning in this session into three parts: the life cycle of a claim, coding systems, and reimbursement. He will explain each of these in depth.

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About the expert: Rich has 30 years of experience in healthcare systems, coding, billing, and reimbursement. He has led managed care departments and provider contracting units at a variety of organizations, including hospitals, clinics, and health plans.

Rich has worked with over 70 different organizations, ranging from hospitals and clinics to third-party administrators, law firms, and internet-based companies. As a respected industry expert, he is well known for his unparalleled depth of knowledge in all aspects of healthcare coding, billing and reimbursement.