Medical device companies need to get their design controls right

Design controls are among the most frequently cited areas for 483 and Warning Letter observations from the FDA, despite the regulatory agency considering this area as critical. It goes without saying that Design Controls are indispensable for ensuring the safety and effectiveness in the production of medical devices. Statistics show that a substantial percentage of all medical device recalls are due to design problems. This is despite the fact that intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase.

When Design Controls are not built strongly enough into the medical devices, these are some of the implications:

o  Design Control flaws are a reason for a significant number of recalls

o  Design Control issues lead to complaints and medical device reports

o  When Design Control is not properly put in place, the manufacturer can face issues related to manufacturability, like low yields and excessive scrap and rework.

The solution is getting trained on Design Control issues and understanding the ways of implementing them

Given the severity of Design Control issues, medical devices manufacturers need to address the problem with one solid solution: Understand how to locate and fix issues early on in the design process. If this is not done, the consequences can be expensive. Finding and fixing problems for medical devices that are already in production is must more expensive than doing so at an earlier stage. What is more; such a process can also make the Design Control less effective.

How do medical device companies ensure a Design Control process that is free of hassles and will serve the primary intention for which it is to be implemented? This is the teaching a two-day seminar that is being organized by GlobalCompliancePanel, a highly regarded provider of professional trainings for the regulatory compliance areas, will impart.

At this seminar, Susanne Manz, an accomplished leader in the medical device industry, who emphasizes quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities, will be the Director.  In order to gain insights into how to imbibe Design Controls into the earliest possible stages of medical device manufacture, please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900852SEMINAR?linkedin_SEO to register for this seminar.

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

An important session on Design Controls

The main intention of this seminar is to provide a clear and deep understanding of the nature and importance of Design Controls in medical devices, and the ways of developing Design Controls processes and tools that are compliant with the regulatory requirements. Susanne will offer these to ensure that they become a competitive strength for their organizations. With this learning, participants can learn from past issues and mend their next generations of product.

An explanation of the requirements for design controls and an understanding of how to translate them into an efficient and effective process for their organizations will be given. Susanne will begin with the history and requirements for Design Controls. The next topic she will take up in detail is the requirements and tools needed to ensure product quality, while also meeting business needs for speed to market.

Also included are exercises to help participants practice what they have learnt here theoretically. At the end of this two-day session, participants will have gained the knowledge needed to improve their design control process.

Susanne will cover the following areas at this seminar:

o  Expectations

o  Regulations and History

o  Design Control process, procedures, forms, records, files

o  Linkages to the rest of your Quality Management System

o  Lessons Learned

o  Myths

o  Challenges

o  Best Practices

o  Inspection Readiness.

Statistics for Medical Professionals

Medical statistics, also called biostatistics, is an important area for medical professionals. Statistics and the medical professionals may not seem very easily associable with each other at first glance, but a deeper look suggests the connection between statistics and the medical profession.

Statistics is a set of data and tables. These figures are meant to offer understanding and perspectives on a number of issues. When it comes to the medical profession; statistics for medical professionals becomes very important to those in the field of public health. Every time a government or an international agency of a world body such as the UN undertakes a program on public health; statistics are of immense importance for medical professionals.

Many uses of statistics for medical professionalsStatistics for medical professionals is useful in helping them analyze public health issues. Detailed figures of the incidence of malaria for instance, are a very useful piece of statistics for medical professionals. This kind of statistics helps them determine the causes of the disease and helps them decide on the plan of action.

Statistics for medical professionals is also useful at the local level. A medical professional working in a town or village could benefit immensely when she has statistics meant for medical professionals. It helps the professional understand what local causes are giving rise to health issues. Statistics for medical professionals thus helps them tackle issues at the local as well as the global levels

A specialized fieldIn developed countries, statistics for medical professionals has become a full-fledged profession. It is finessed at graduate and postgraduate programs at which they study the essentials of statistics for medical professionals. They then carry out programs that are suited for their profession.

Statistics for medical professionals is used in a wide variety of disciplines. Usually, courses on statistics for medical professionals cover the following areas:

  • Data Analysis of statistics for medical professionals
  • Dealing with Missing Data
  • Higher Issues in Trials
  • Linear Regression and Correlation
  • Logistic Regression
  • Correlated Data analysis
  • Continuous Data comparison between groups
  • Survival Data analysis
  • Risk, Rates and Odds of statistics for medical professionals
  • Randomized Trials
  • Observational Studies of statistics for medical professionals
  • Categorical Data comparison between groups
  • Calculations of Sample Size
  • Testing of Estimation and Hypothesis

More information go through this link: https://www.globalcompliancepanel.com/seminar?Linkedin_SEO

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

Applying ISO 14971 and IEC 62304 to medical device software

158245439.jpg

Risk management of software used in medical devices has to be implemented diligently, completely and correctly, scrutinizing the gaps thoroughly and correcting them right from the very start of product development. This is critical because of the following reasons:

  1. Medical products that have gaps or are implemented incorrectly or incompletely suffer serious ailments such as impediments or delays in production. Further, such products fail to get the required certification and/or approval;
  2. Given the close linkage between most activities and the development lifecycle; almost no activity can be isolated and performed with retrospective effect after detection of a gap. As a result, all the activities performed till the identification of gaps become unproductive and redundant. When this happens, the company has to start from the beginning, irrespective of the stage at which an anomaly gets detected, incurring huge delays and cost overruns.

The solution to these problems is to embed software risk management into the bigger scope of overall risk management. This is the only real solution to problems associated with faulty product development. Globally applicable standard requirements such as ISO14971 and IEC62304 are major guidelines that help medical device companies get the risk management of software used in medical devices right. These standards have made risk management central to and a mandatory component of almost any activity in the medical device industry.

Getting it right from start till finish

Regulatory requirements set out in ISO14971 and IEC62304 standards that deal with risk management of software used in medical devices need to be implemented in the right manner, if medical device companies have to clear regulatory hurdles and meet quality standards. Expert professional trainings that help them do this will give them an understanding of how to design, implement and test critical medical device software in a regulatory compliant environment.

All these will be part of a learning session that is being organized by GlobalCompliancePanel, a very well-known provider of professional trainings for the regulatory compliance areas. This two-day, live seminar will have Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, as the course Director.

To gain the benefit of expert training from the Director of this seminar; please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900750?wordpress_SEO  to register.

Globally applicable standard requirements

Markus will explain the requirements set out by international consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, which has led to risk management being a mandatory component of almost any activity in the medical device industry.

Since the need to embed software risk management into the bigger scope of overall risk management is a critical aspect; Markus will introduce all the steps needed for designing, implementing and testing core medical device software in a regulatory compliant environment, even as they adhere to the principles of risk management. Another important learning Markus will impart is system level risk management and the resulting interfaces to software.

The safety case method

A well-established method for collecting and consolidating all safety related information together in one location, so that all risk related activities are comprehensively summarized, and the safe properties of a device demonstrated, is what is called the ‘Safety Case’ or ‘Assurance Case’ document.

Although as of now, the FDA requires this method for only infusion pump submissions; this system of documentation is almost certain to become standard practice in the future across all devices that come up for approval. At this course, Markus Weber will introduce the basic concepts and content of safety assurance cases. He will also explain and illustrate their utility for internal and external review of safety related information.

Tips for practical application of risk management principles

Real-life examples and proven tips and tricks that make the application of risk management practical and beneficial will be offered at this webinar. The Director will describe the system level issues of risk management as well as the increasingly important software related issues of critical systems.

He will introduce the concept of an assurance case to make the combined effort needed to design, implement and verify a safe device transparent. An important outcome of this learning is that it will help participants to meet and comply with regulatory requirements with highly lessened overheads and resource burdens.

Supplier Management Conference for Medical Device Manufacturing in HONG KONG

 

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 supplier management program. This is why the Good Manufacturing Practice (aka Quality System Regulations) is called cGMP. The C stands for current, meaning what the FDA considers the current state of the art in the areas they regulate. Also European Notified Bodies also periodically update their expectations, and for suppliers this happened with the publication of a guidance document by the Notified Body Operations Group (NBOG).

This seminar will go into the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation on supplier management.

One of the major things introduced in these guidance document, is the concept of Risk, and the use of identified risks as part of the evaluation and monitoring of suppliers.

This seminar will review requirements and expectation of the FDA and European Notified Bodies for supplier management, and then how to incorporate these into your own supplier management process.

Areas Covered in the Session:

  • Understand FDA QSR and ISO 13485 requirements for supplier management
  • Creating a Risk-based Multi-tier supplier classification system
  • Understand when suppliers have to register and list with the FDA
  • Defining and using supplier Metrics
  • Explain the link between design control and purchasing data
  • Develop an risk-based supplier management process
    • Incorporating supplier regulatory and safety risk
    • Incorporating supplier business risk
  • Create supplier measurement and monitoring systems
  • Understand the how to develop and implement supplier controls
  • Create a risk based Value-added system for supplier audits
  • How to prepare yourself and your contract manufacturer for unannounced audits from your Notified body
  • Creating acceptance criteria and understand how that fits into your supplier control process

Who will benefit:

  • Quality Managers
  • Quality Engineers
  • Audit Managers
  • Supplier Engineers
  • Internal quality auditors
  • Supplier auditors
  • Quality associates
  • Quality Specialists
  • Regulatory Compliance Managers

Agenda:

Day 1 Schedule

Lecture 1:

Introductions

Lecture 2:

Fundamentals Regulatory Requirements

  • FDA Requirements
  • ISO 13485 requirements
  • Understanding the role of the Global Harmonization Task Force Guideline
  • Understanding NBOC Guideline and why it should be used

Lecture 3:

Planning the Supplier Management Program

  • Supplier Classification
  • Supplier QA agreements what are they and why are then

Day 2 Schedule

Lecture 1:

Planning Supplier Selection

Lecture 2:

Potential Suppliers

Lecture 3:

Supplier Selection

Lecture 4:

Implementing Supplier Controls

Lecture 5:

Monitoring, Measuring, and Evaluation

  • Periodic Monitoring
  • Re-evaluations

Lecture 6:

Supplier Audits – where do they add value

  • Planning your supplier audit schedule
  • How Notified Body unannounced audits affect your contract manufacturer
  • What you should do to prepare yourself and your contract manufacturer for unannounced Notified body audits

Lecture 7:

Feedback and Communication

  • Supplier meetings: Partnering with Key suppliers
  • Supplier Corrective Actions

Lecture 8:

Evaluating your current program to see how it measures up to regulatory Expectations

Speaker:

Betty Lane,

Founder and President, Be Quality Associates, LLC

Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Betty’s training experience includes over 25 years of training on all aspects of ISO 13485, the ISO standard for Medical Device – Quality Management Systems – System Requirements for regulatory purposes, and FDA Quality System Regulation – Medical Devices; Good Manufacturing Practice (cGMP), in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.

Location: Hong Kong Date: April 6th & 7th, 2017 and Time: 9:00 AM to 6:00 PM

 

Venue: INTERCONTINENTAL HONG KONG

Address: 18 Salisbury Road, Kowloon, Hong Kong

 

Price:

 

Price: $1,695.00 (Seminar Fee for One Delegate)

 

Until February 28, Early Bird Price: $1,695.00 from March 01 to April 04, Regular Price: $1,895.00

 

Register for 5 attendees   Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*

 

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

 

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900878SEMINAR?channel=mailer&camp=seminar&AdGroup=wordpress_April_2017_SEO

Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel

 

 

 

 

 

 

 

 

 

 

 

ISO 14971: 2012 and IEC 62304: 2006 mitigate risks in medical device software

ISO 14971:2012 and IEC 62304:2006 are related but different global standards for risk management pertaining to software used in medical devices. Judicious application of these two standards is the way to go for medical device companies.

ISO 14971 and IEC 62304:2006 are global standards that govern risk management and lay out regulations and guidelines for software used in medical devices. The need for regulation of software in medical devices arises from the fact that software is the heart of a medical device. It is the medical device’s software that ensures that the device performs its intended purposes. Hence regulation is of utmost importance to enable medical device and software organizations facilitate this in their products.

The ISO 14971: 2012 -a brief understanding

  • The primary aim of ISO 14971, the global regulatory compliance standard is to ensure that a medical device carries medical safety into it
  • This standard requires medical device manufacturers to undertake steps and measures by which they can foresee and eliminate risks in a medical device in the optimal manner
  • Taking off from the above point, ISO 14971 requires medical devices to take steps to at least mitigate risks to the best extent. The ISO 14971standard prescribes the processes necessary for enabling this.

The ISO 14971’s update in 2012

In 2012, the ISO carried out an update to the application of this standard within the European regulatory framework. This amendment to ISO 14971: 2012 is at the periphery and not at the core. Annex ZA is the main area in which this standard has been updated:

The use of the “As Low as Reasonably Practicable” (ALARP) approach is from now excluded in the risk acceptance process. This standard proscribes labelling as a risk control measure that can play a role in decreasing risk occurrence.

The IEC 62304:2006

The requirements for medical device software’s life cycle are stated in IEC 62304:2006. This standard’s group of activities, processes and tasks creates a common basis for the software life cycle processes in a medical device.

When it comes to the risk management aspect, IEC 62304:2006 supplements and strengthens ISO 14971. If ISO 14971 is the global standard for the development of medical software; IEC 62304:2006 standard is concerned with medical device software and their software lifecycle processes.

The following tripod of software-related issues forms the IEC 62304:2006’s foundation:

These three attributes form the backbone of the test of a medical device company’s successful compliance with the regulatory requirements. For a medical device company to be successful in applying ISO 14971:2012 and IEC 62304:2006; it has to implement a cross-standard and resourceful way of integrating activities covering these requirements documents.

Read More