An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls

Adverse Event Reporting, and Recalls4

The fact that medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other is recognized and empathized by the new ISO version, the ISO 13485:2016. Because of the divergence in the requirements of each regulatory system; manufacturers are required to identify their roles, as well as the regulatory requirements for that role, and then incorporate them into their Quality Management System.

When it comes to post-market device issues; the various jurisdictions, however, deal with these in different ways. Three interlocking, interrelated processes need to go into the QMS:

  • Complaint management
  • Adverse event reporting
  • Recalls

Supporting QMS processes such as corrective action and design changes also need to complement these three processes. Over and above the QMS processes come the regulatory requirements, which usually involve areas such as recordkeeping and reporting.

A complete learning on how to implement an integrated QMS

Adverse Event Reporting, and Recalls3

A highly educative and valuable learning session on these primary and secondary QMS processes and the way they need to be understood and implemented vis-à-vis the US, EU, and Canadian regulations is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

The Director of this two-day seminar is Dan O’Leary, who is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, which focuses on analytic skills and a systems approach to operations management. Dan brings more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.

To understand the way in which to implement an integrated QMS in which the various aspects of complaints, adverse reporting and recalls are built; please register for this seminar by visiting An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Alignment with the FDA’s QMS is a major point

Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach

One of the highlights of the final version of the ISO 13485:2016 standard, which has now become available, is the extent of its alignment with the FDA’s Quality Management System (QMS) requirement. Although the degree of alignment set out in 2016 version of 13485 is significantly higher than that of the previous version of 2003; there still do exist a few points at which it deviates from the FDA’s QMS. Companies that are required to comply with this standard have to keep this in mind.

Now that the ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), and the new EU Medical Device Regulation have been introduced; companies need to update their QMS and integrate all of the elements if their implementation has to be effective and compliant. At this two-day session, Dan will provide the tools that the participants will need for this.

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The agenda of this learning session will be the following:

  • The Regulatory Structure
  • FDA QSR
  • ISO 13485:2016 and regional variants
  • ISO 14971:2007 and regional variants
  • Implementing MDSAP
  • The EU Medical Device Regulation
  • Servicing
  • Identification of problems
  • Servicing data analysis
  • Input to the complaint process
  • Complaints

Identifying complaints

  • Evaluating complaints
  • Investigating complaints
  • Complaint data analysis
  • Input to the corrective action process
  • Input to the risk management process
  • Corrective Action
  • Developing the process
  • Analyzing product and process information
  • Determining subsequent actions
  • Input to the design process
  • Input to the risk management process
  • Design and Design Changes
  • Determining the need for a design change
  • Documenting design changes
  • Design change verification and validation
  • Input to the risk management process
  • Input to the pre-market submission process
  • Risk Management
  • ISO 14971:2007 and regional variants
  • Incorporating post-market information
  • Updating Pre-market Submissions
  • US – The 510(k) guidance
  • EU – Technical files and design dossiers
  • Canada – License changes
  • Adverse Event Reporting
  • US – MDR
  • EU – Vigilance Reports
  • Canada – Mandatory Problem Reporting
  • Recalls
  • US – Corrections and Removals
  • EU – Field Safety Corrective Actions
  • Canada – Recall.

 

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

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Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till April 30. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit https://www.globalcompliancepanel.com/seminar?wordpress_SEO and use MGCP50 Promo Code.

This offer is valid till April 30, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

 

 

Design of Experiments (DoE) for Process Development and Validation

Design of Experiments (DoE) is a very important process development and validation component in several kinds of industries. DoE for process development and validation involves carrying out a number of tests recurrently and steadily over a period of time. Its responses are then observed.

DoE is important for process development and validation as it offers an understanding of the predictability and reproducibility of an experiment. Fundamentally, Design of Experiments for process development and validation seeks to rule out fluke or chance in the methods needed for bringing about control for a product.

DoE in medical devices

In the area of medical devices, guidelines for Design of Experiments for process development and validation are set out in the Global Harmonization Task Force (GHTF) Process Validation Guidance for Medical Device Manufacturers. This document offers guidance in the area of Design of Experiments for process development and validation by suggesting the exact areas in which design of experiments should be applied during Process Validation.

The GHTF guidance also suggests the use of both screening and response surface designs during Operational Qualification. It further requires Design of Experiments for process development and validation to be used during various phases of design controls. These include:

o  Design and development planning

o  Design verification

o  Design validation

o  Design transfer

o  Design changes.

Get a full understanding of Design of Experiments for process development and validation

The ways of approaching Design of Experiments for process development and validation will be topic of a two-day seminar that is being organized by GlobalCompliancePanel, a highly respected provider of professional trainings for the areas of regulatory compliance.

Jim Wisnowski, who is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, will be the Director at this seminar. In order to gain a full understanding of the principles and application of Design of Experiments for process development and validation; please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900794?linkedin-SEO .

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All about Design of Experiments for process development and validation

This seminar will offer total and all-round understanding of all the aspects of Design of Experiments for process development and validation.

Process development studies need to be completed before a process control plan is developed as part of an overall risk management strategy. These process development studies help gain knowledge and understanding about the impact of variation in process parameters on the variation in the product quality characteristics of the product.

An explanation of the methods used

The methodology of Design of Experiments for process development and validation offers a means for identifying process parameters, which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to those critical quality attributes.

Design of Experiments for process development and validation uses screening designs such as 2k factorial and D-optimal designs to determine critical process parameters. Design of Experiments for process development and validation use response surface designs, such as Central Composite Designs (CCDs) and I-optimal designs for fashioning the functional relationship between those critical process parameters and the critical quality attributes.

A primer on statistical analysis

This seminar on Design of Experiments for process development and validation will present a primer on statistical analysis, during which it will focus on the methods required for analysis of designed experiments. Jim will then move on to the steps to a proper DoE, during the process of which he will demonstrate the nature and uses of important risk management tools such as Ishikawa and FMEA, which can be used pre and post DOE studies.

The Director will also teach how to generate and analyze multiple screening and response surface designs, and why and how each are used. After teaching participants how to present the results, Jim will explain how to update the risk management tools using the results of the studies.

This session on Design of Experiments for process development and validation will cover the following areas:

o  Identify critical quality attributes (CQAs) that will be used as responses in your designs

o  Utilize risk management tools to identify and prioritize potential critical process parameters

o  Identify critical process parameters and develop a functional relationship between those process parameters and your critical-to-quality attributes (CQAs) using both screening and response surface designs

o  Be able to design and analyze screening designs including a factorial, fractional factorial, and D-optimal design

o  Understand the need for adding center points to a design

o  Be able to design and analyze response surface designs including central composite designs (CCDs), Box-Behnken designs, and I-optimal designs

o  Present results of DOE studies

o  Use systematic understanding from DOE studies to update the control plan that is part of the overall risk management plan.

All about HIPAA compliance

all-in-one-HIPAA-Compliance

HIPAA compliance is a must for Covered Entities and their Business Associates. It is a sine qua non requirement from the Department of Health and Human Services (HHS), a US federal department that is charged with the responsibility of enhancing and protecting the wellbeing and health of all Americans. It provides the means for bringing about effective health, as well as human services. Its mission is to engender improvements and developments in the fields of public health, medicine and social services.

The HHS requires complete compliance with its laws by a Covered Entity and its Business Associate. The HHS’ Office for Civil Rights (OCR) considers Covered Entity as one that is involved in generating, storing, receiving or transmitting electronic Protected Health Information (PHI). A Business Associate is one that does all these on behalf of its affiliated CE. HIPAA compliance is mandatory because the nature of information that Business Associates carry with them –Protected Health Information –is of a highly confidential and sensitive nature. Not only that; when there is a breach of data on the part of the Business Associate or the Covered Entity, it results in huge costs by way of damages. Data breaches also carry a bigger penalty: They dent the reputation of the business, something no money can compensate.

Locating the source of data breach

Most of the patient information breaches take place at the Business Associate’s end. This makes compliance with HIPAA compliance rules by BA’s all the more important. The basic reason for which most such breaches take place is the many misconceptions that abound among healthcare organizations about the nature of the HIPAA privacy and security regulations. What these regulations are, what they mean to healthcare organizations, and the steps that the healthcare organizations, Covered Entities and their Business Associates need to do –all these are areas of considerable confusion.

It is to equip professionals from the healthcare industry with the complete knowledge needed to understand and implement HIPAA compliance that GlobalCompliancePanel, a highly popular provider of professional trainings for all the areas of regulatory compliance, will be organizing a two-day seminar.

A complete roundup of HIPAA compliance

Senior healthcare professional Jim Wener, who brings four decades of experience in the industry and has been assisting providers and payers in identifying their automation requirements and helping them select and successfully implement the ideal automation for their needs, will the Director of this seminar. To gain the benefit of the vast experience that Jim brings and to ensure total HIPAA compliance for your organization; please register for this seminar by logging on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900874?wordpress-SEO.

Questions, questions, questions

At this seminar, Jim will take the participants through HIPAA compliance from start to compliance. He will provide answers to all the questions that Business Associates and Covered Entities face during the process of ensuring HIPAA compliance. He will show what healthcare organizations need to do to secure their healthcare information.

Some of the questions that he will seek to answer include:

Do the HIPAA regulations apply to the organization? What risks does the organization face, and how does it mitigate these risks? What is it that the organization is required to do, and how is this done? Is there a role assigned for and expected of the organization’s computer resources in assessing and managing HIPAA compliance risks? What is the level of safety that the healthcare organization’s computer and paper patient information carry? Is there a way by which the organization determines if its computer resources provide the needed features and functions for the organization to become compliant?

Diligence can lessen the severity of penalties

These are just some of the questions for which Jim will seek to provide answers. Framing these questions and answering them is a watertight means to developing and executing a compliant plan. This in turn is critical to ensure that the organization takes the right path in ensuring HIPAA compliance. A breach is a very bad thing to happen for an organization, but diligence that the organization has showed in protecting patient information will go a long way in mitigating penalties. This is one of the prime reasons for which attendance at this seminar is necessary.

  • 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.

https://www.hhs.gov/about/index.html

 

GlobalCompliancePanel Professional Training and Development Courses with Flat 50% OFF on all Seminars

Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till March 31. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit http://www.globalcompliancepanel.com/ and use MGCP50 Promo Code.

This offer is valid till March 31, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

GMPs for API Bulk Manufacturers

Till recently, till 2001 that is, Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs) bulk manufacturers was carrying a bulky load on its shoulders, so to speak. GMP for active pharmaceutical ingredients (APIs) per se had no independent guidelines. The GMPs that they were to follow and implement were bunched with those of APIs for bulk manufacturers. So, GMPs for API bulk manufacturers consisted of GMPs for both APIs and API bulk manufacturer.

All that changed, however, in 2001, with the FDA’s issuance of a draft guideline called Q7A, which was meant separately and exclusively for APIs alone. This draft guideline was meant solely for APIs, and GMPs for API bulk manufacturers were exempt from the provisions of the new guideline.

No clear guideline yetThat said, while the FDA draft guidance of 2001 merely separated GMPs for APIs; it did not make any changes to the existing GMPs for API bulk manufacturers, which continued to remain the same and continued to suffer the same insufficiency. The major deficit that plagued GMPs for API bulk manufacturers continued to do so. As in the past, there was no guideline on GMPs for API bulk manufacturers at all. Instead, all that was required was that bulk manufacturers go by their heart. In other words, the onus of maintaining GMPs for API bulk manufacturers was left to them, based on their unique individual needs and situations.

Leaves it to the individual pharma organizationThe FDA and other regulatory bodies merely require that established practices be followed as GMPs for API bulk manufacturers. This, as noted, leaves the task of ensuring that conception and implementation of all-round GMPs for API bulk manufacturers to the individual organization, based on its discretion and assessment of what it deems as appropriate. The following are the areas into which pharmaceutical organizations may take steps at implementing GMPs for API bulk manufacturers:

  • Manufacturing equipment
  • Components that go into the materials and packaging
  • Requirements relating to record-keeping
  • Facilities and buildings
  • Personnel
  • Process controls
  • Laboratory controls

Learn more on this topic for your reference: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900964SEMINAR?Linkedin-SEO

Applied statistics for scientists and engineers

Applied statistics for scientists and engineers is necessary for a number of reasons. 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries specify the application of statistical methods for these functions:

o  Setting validation criteria and specifications

o  Performing Measurement Systems Analysis (MSA)

o  Conducting stability analysis

o  Using Design of Experiment (DOE) for process development and validation

o  Developing process control charts, and

o  Determining process capability indices.

Since scientists and engineers are at the heart of these functions, they need to have a thorough knowledge of how to use applied statistics. Each of these particular applications requires different and specified statistical methods. The common tools used for setting acceptance criteria and specifications are data and tolerance intervals, while for setting expiries and conducting stability analysis studies; simple linear regression and analysis-of-covariance (ANCOVA) are used.

For analyzing designed experiment for process development and validation studies, two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used, while for developing process control charts and developing process capability indices; descriptive statistics (distribution, summary statistics), run charts, and probability (distributions) are used.

Explaining the importance of applied statistics for scientists and engineers

A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will explain the importance of applied statistics for scientists and engineers.

In the course of making the importance of applied statistics for scientists and engineers known; the Director at this seminar, Heath Rushing, who is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, and has been an invited speaker on applicability of statistics for national and international conferences, will provide instruction on applied statistics for scientists and engineers and statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries.

To enroll for this highly valuable and practical course on applied statistics for scientists and engineers, just register by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900790?wordpress_SEO .

The course “Applied Statistics for Scientists and Engineers” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The tools that help an understanding of applied statistics for scientists and engineers

This course on applied statistics for scientists and engineers will offer thorough instruction on how scientists and engineers need to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building. The Director will present the ways of establishing competence in each of these areas and industry-specific applications.

The application of statistical methods across the product quality lifecycle is specified in the 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries. There are many statistical methods that may be applied to satisfy this portion of the QSR. Yet, some commonly accepted methods can and should be used by all companies to:

o  Develop acceptance criteria

o  Ensure accurate and precise measurement systems

o  Fully characterize manufacturing processes

o  Monitor and control process results and

o  To select an appropriate number of samples.

At this seminar on applied statistics for scientists and engineers, Rushing will provide instruction on all these. He will cover the following areas over the two days of this seminar:

o  Describe and analyze the distribution of data

o  Develop summary statistics

o  Generate and analyze statistical intervals and hypothesis tests to make data-driven decisions

o  Describe the relationship between and among two or more factors or responses

o  Understand issues related to sampling and calculate appropriate sample sizes

o  Use statistical intervals to setting specifications/develop acceptance criteria

o  Use Measurement Systems Analysis (MSA) to estimate variance associated with: repeatability, intermediate precision, and reproducibility

o  Ensure your process is in (statistical) control and capable