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

How to link these processes link to other parts of your Quality Management System. We’ll cover best practices so you can be prepared for a possible post-recall FDA inspection.

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.

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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.

Virtual Seminar on Upcoming Changes with HIPAA 2019

What factors might spurn a lawsuit or a HIPAA audit? are you doing these things?

We will go point by point through the entire HIPAA Security Rule and uncover simple methods to comply and create policy.
The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do’s and don’ts with HIPAA – I want to add clarity for compliance officers.

It will also address major changes under the Omnibus Rule and any other applicable updates for 2018.

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Do you know all of the requirements of this enigmatic law? Are you abiding by them?

My goal is to make this extremely complex enigma known as “HIPAA” very easy to understand with a painless step by step approach to an otherwise harrowing task Times have changed and new laws are now in place concerning protected health information.

The best way to protect your practice or business and save yourself future headaches and possible litigation or Federal fines is to be proactive instead of reactive This once rarely enforced law has changed and you need to know what’s going on! Protect your practice or business!

These day’s trial attorney’s pose an even higher risk than the Federal government!

State laws are now in place increasing liability for patient remedies!

What factors might spurn a lawsuit or a HIPAA audit? are you doing these things?

We will be discussing 2019 changes taking place in Washington with the Health and Human Services regarding the enforcement of the HIPAA laws already on the books as well as some detailed discussions on the audit process and some current events regarding HIPAA cases (both in courtrooms and from live audits)

What are areas covered by the Instructor:

  • Study all 18 Standards and 44 Implementation Specifications of the regulations
  • Updates for 2019
  • Requirements of Compliance Officers
  • New definition of what constitutes protected health information
  • Real life litigated cases
  • BYOD
  • Portable devices
  • Business associates and the increased burden
  • Emailing of PHI
  • Texting of PHI
  • Federal Audit Process
  • HIPAA and suing – how this works
  • Risk Assessment
  • Best resources

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21 CFR PART 11: Complete Manual for Compliance Success

FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to support these activities.
21 CFR PART 11 Complete Manual for Compliance Success

The number of warning letters is increasing proportionally and we as quality and other professionals utilizing the technology and systems to support our businesses are not ready – we are not ready to prepare and host FDA inspections when Part 11 is in scope, we are unsure how to best use and implement Audit Trails and certainly we have challenges with internal and external auditing for Part 11 compliance. This webinar address all these topics and provides you with plenty HOW TO we as auditors and inspectors increase our comfort level with the regulation, with its elements and compliance and practically implement audit system and audit trails – especially since Audit Trails play major role in Part 11 compliance – they can be your best friends and/or worst enemies at the same time.

Areas Covered in the Seminar:

  • How to Prepare and Host FDA Inspections (will cover elements and details of preparation for the inspection as well as elements of the successful practices of hosting an FDA inspection when Part 11 is in scope or the scope of the inspection. We will also cover some commonly asked questions by the inspectors and benefits of being compliant)
  • Internal and External Auditing for Part 11 Compliance (this subtopic includes all aspects of auditing for Part 11 compliance- starting at the audit program level and then going down on how to prepare for an audit to how to successfully execute the audit and follow up on the completed audit. This subtopic also includes CAPA and responses for the audit findings related to Part 11 – what to expect and handle the difference between “regular” audits and Part 11 audits. We include some of the common audit findings and common pitfalls as well as tools for a successful planning and execution of the audit.)
  • Audit Trails (includes types of audit trails, strategies for implementing complaint audit trails, proms and cons of audit trails, how to use audit trails as an audit tool during the internal and external audit as well as during the FDA inspection visit, some examples of “should” and “shouldn’t” when it comes to the audit trails and commonly asked questions related to audit trails.)
  • Overview and Understanding of the Regulation (covers topics such as introduction and development of the regulation, what to expect in the future when it comes to the regulation, options for (non)compliance, “what ifs”, as well as most impactful sections and subsections of the regulations.)
  • How Part 11 Regulation Relates to Other Regulations (this subtopic compares the Part 11 regulation with other regulations focusing on commonalities so that you and your organization can see how easy/hard is to identify gaps as well as how harvest the low hanging fruits when striving to comply with Part 11 regulation. We cover comparison with 3-4 other regulations quoting the exact subsections of each.)
  • Sample Audit Questions (throughout the material, we ensure that we present you and prepare you to deal with some commonly asked audit and inspection questions. These questions are ready-made for you to use when you and your team are conducting internal and/or external audits, but they are also ready-made for you and your team to use as you prepare to/and host FDA inspection when Part 11 in scope of the inspection. We include some of the questions in the material presentation and in addition to that we provide you with additional 30+ commonly asked questions document which you can use for your references and training purposes.)
  • Trends; Warning Letter Examples; Advantages and Challenges of the Regulation (we conducted research to bring you and your team results of inspections and audits that have been conducted in past several years. We include trends and graphs showing how and where Part 11 regulations impacts you the most, but will also show examples of the warning letters that have been issued in last several years due to lack of compliance with the Part 11 regulation. Finally, we cover and include some examples of advantages and challenges you may be benefiting from or facing to address while striving to be Part 11 compliant.)
  • More (we talk about the importance and significance of the regulation regardless if it (currently) applies to you or not. We provide examples and HOW TO so that you and your team can get most out of the materials and presentation – and to be able to use it immediately after attending this training/webinar.)

Who Will Benefit:

  • Quality Managers
  • Quality Engineers
  • Manufacturing engineers
  • CAPA investigators
  • Inspectors
  • Six Sigma specialists
  • Consultants
Speaker Profile

Jasmin NUHIC serves a major medical devices OEM as a Sr. Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation.

Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

It is also critical that the system specify the exact meaning of the signature. It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result. A person may simply be attesting to the fact that they reviewed the work and the signatures, and there was appropriate segregation of duties (i.e., the person recording the result is not the same as either the person reviewing or the person giving final approval).

A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability. These must clarify the 21 CFR Part 11 regulation and provide insight as to the way the company interprets their responsibility for meeting it. As FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt.

New technologies will continue to emerge that will change the way companies do business. While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a computer system validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.

Why you should attend

FDA requires that all computer systems that handle data regulated by the Agency be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.

The guidance was revisited for its application to the medical device industry in the 1990s, as the first issuance addressed pharmaceuticals only. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many FDA-regulated organizations began seeking ways to move into a paperless environment.

This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures, but still remains somewhat confusing. The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.

This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.

Who Will Benefit

  • Information Technology Analysts
  • Information Technology Managers
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
  • Auditors Engaged in Internal Inspection

Session 1 (90 Mins):

  • FDA Regulatory Oversight
  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • GAMP 5 Software Categorization
  • System Risk Assessment

Session 2 (90 Mins):

  • 21 CFR Part 11 Compliance (Electronic Records/Electronic Signatures)
  • Security, Access, Change Control and Audit Trail
  • Validation Documentation

Session 3 (90 Mins):

  • 7 Most Common Problems with Validation
  • FDA Audit Preparation

Session 4 (90 Mins):

  • Policies and Procedures
  • Training and Organizational Change Management
  • Industry Best Practices and Common Pitfalls
  • Q&A

Speaker Profile

Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She 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. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

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Seminar on Biostatistics for the Non-Statistician

Why should you attend:

Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.

Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test?

This seminar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

The focus of the seminar is to give you the information and skills necessary to understand statistical concepts and findings as applies to clinical research, and to confidently convey the information to others.

Emphasis will be placed on the actual statistical (a) concepts, (b) application, and (c) interpretation, and not on mathematical formulas or actual data analysis. A basic understanding of statistics is desired, but not necessary.


Who will benefit:

  • Physicians
  • Clinical Research Associates
  • Clinical Project Managers/Leaders
  • Sponsors
  • Regulatory Professionals who use statistical concepts/terminology in reporting
  • Medical Writers who need to interpret statistical reports

Day 1 Schedule


Lecture 1 (90 Mins):

Why Statistics?

  • Do we really need statistical tests?
  • Sample vs. Population
  • Statistician ≠ Magician. What statistics can and can’t do.
  • Descriptive statistics & measures of variability.

Lecture 2 (90 Mins):

The many ways of interpretation

  • P-values
  • Effect sizes
  • Confidence intervals
  • Statistical vs. Meaningful significance

Lecture 3 (90 Mins):

Common Statistical Tests

  • Why Test? Null Hypothesis Significance Testing (NHST)
  • Comparative tests
  • Correlation
  • Multiple Regression analysis
  • Non-parametric techniques

Lecture 4 (90 Mins):

Bayesian Logic

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

Day 2 Schedule


Lecture 1 (90 Mins):

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

Lecture 2 (90 Mins):

Study power and sample size

  • Review of p-value, significance level, effect size and how they are use in sample size calculations
  • Formulas, software, and other resources for computing a sample size.

Lecture 3 (90 Mins):

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.

Lecture 4 (90 Mins):

Specialized topics/Closing Comments/Q&A

  • Logistic Regression.
  • Comparing survival curves
  • Cox Regression
  • Question and answer session.

Speaker

Elaine Eisenbeisz

Owner and Principal Statistician, Omega Statistics

Elaine Eisenbeisz, is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has 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.

In addition to her technical expertise, Elaine possesses a talent for conveying statistical concepts and results in a way that people can intuitively understand.

Elaine’s love of numbers began in elementary school where she placed in regional and statewide mathematics competitions. She attended University of California, Riverside, as a National Science Foundation scholar, where she earned a B.S. in Statistics with a minor in Quantitative Management, Accounting. Elaine received her Master’s Certification in Applied Statistcs from Texas A&M, and is currently finishing her graduate studies at Rochester Institute of Technology. Elaine is a member in good standing with the American Statistical Association as well as many other professional organizations. She is also a member of the Mensa High IQ Society. Omega Statistics holds an A+ rating with the Better Business Bureau.

Elaine 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 nutriceutical and fitness studies with QPS, a CRO based in Delaware. Elaine has also worked as a contract statistician with numerous private researchers and biotech start-ups as well as with larger companies such as Allergan and Rio Tinto Minerals. Not only is Elaine well versed in statistical methodology and analysis, she works well with project teams. Throughout her tenure as a private practice statistician, she has published work with researchers and colleagues in peer-reviewed journals. Please visit the Omega Statistics website at http://www.OmegaStatistics.com to learn more about Elaine and Omega Statistics.

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200+ followers. WOWWWWWW…

followed- 200

Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

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Statins ‘should be given to children with heart risks before the age of 10’

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Statins should be given to thousands of children by the age of 10 under radical new NHS guidance.

GPs are being urged to identify those who have an inherited risk of high cholesterol, amid warnings that the vast majority of cases are going undetected.

Estimates suggest up to 260,000 people – including 50,000 children – are suffering from genetic deficts which affect the body’s ability to break down cholesterol.

New guidance from the National Institute for Health and Care Excellence (Nice) today says statins should be offered to such cases, to reduce their risk of heart or stroke in midlife.

Just 15 per cent of those with the condition are being treated for it, Nice said, including just 600 of 56,000 children with the genetic problem.

Family doctors are being asked to trawl records to idenitfy those with very high cholesterol levels.

Where levels of more than 9 mmol/l are found in those over 30, and those of 7.5 mmol/l are found in those under 30, high-dose statins should be offered, the NHS guidance states.

And it says gene tests should be used to find other family members – including those below the age of 10 – who are at such heightened risk that they should be put on medication.

Around 56,000 children are estimated to suffer from familial hypercholesterolaemia (FH), yet just 600 have been diagnosed, charities say.

The condition gives men a 50 per cent chance of suffering a heart attack or stroke before the age of 50, while women have a one in three chance by the age of 60.

To continue reading