Understanding the infinite area of medical device compliance

With a seemingly unlimited number of products coming under the broad umbrella of medical devices; it is but natural that regulations for these products are equally expansive. This makes medical devices compliance an extremely enormous and broad topic.
With the FDA being the sole regulator for this very vast area; it comes up with regulations, and expects medical device manufacturers to comply with them. This is part of the FDA’s primary function of assuring quality from medical devices. Compliance with these medical device regulations ensures that companies’ products meet the quality and safety and integrity of medical devices.
Areas of medical device compliance regulations

The FDA’s regulation of medical devices and a few nonmedical devices cover the areas of manufacturing, repackaging, and relabeling, and/or importing. The regulations for medical devices are set out in 21 CFR Part 807, whose various sections detail all the requirements for compliance for Class I, II and III medical devices. The following are the activities connected with compliance for medical devices:

• Registration of the establishment
• Listing of the medical device
• 510 (k)
• Premarket approval
• Investigational Device Exemption (IDE)
• Quality Systems
• GMP
• Device labeling
• Device reporting.

A thorough understanding of the FDA medical device compliance areas
The ambit of the FDA’s regulations being very wide; it is important for medical device companies to have clarity on the many FDA medical device compliance regulations. This understanding will be offered at a seminar being organized by GlobalCompliancePanel, a very well-known provider of professional trainings for the areas of regulatory compliance.
The Director of this two-day seminar is Susanne Manz, Quality and Compliance Expert/Auditor for Medical Devices, Manz Consulting, Inc.
Please register for this webinar by visiting Understanding the infinite area of medical device compliance . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Helping to strategize compliance for medical devices

Medical device companies need to put in place a sound strategy for medical device compliance. A certain level of strategic thinking alone ensures this. Susanne will show participants how to inculcate this thinking and instill it into the organization. She will show how to be cost-effective while improving the quality and compliance of medical devices. The ways of building a sound Quality System, which is at the root of medical device compliance; will be imparted.
An effective and efficient Quality System can only be implemented based on a thorough understanding of what the regulatory requirements mean, and adapting them into the Quality System. The ways of doing this will be the core of this seminar. Susanne will demonstrate the ways by which to plan, structure and implement a Quality System that addresses the specific business needs of the participants.
Addressing issues within a Quality System

The methods for identifying, prioritizing and analyzing risks will be explained during the discussion on how to create a quality strategy and plans. Susanne will help participants explore the capabilities needed for every medical device to meet quality standards and implement compliant Quality Systems.
Also taken up for discussion are areas related to continuous improvement, Six Sigma, and Corrective and Preventive Action (CAPA), which are important components for addressing issues within a medical device company’s Quality System. Susanne will help with this very important aspect.
Over these two days, Susanne will also take up other crucial aspects of medical device compliance. These include:

• Effectively communicating and escalating risk
• Monitoring performance and progress
• Kick starting the Quality System to avoid common problems such as MDRs, recalls, 483s, and Warning Letters.

Susanne will cover the following areas at this seminar on medical device compliance:

• Quality System Expectations
• Quality System Structure
• Strategy and Planning
• Risk management in your quality system
• Case for Quality
• Inspection preparedness and management
• Monitoring and metrics
• Creating a quality strategy and plans.

continue to improve the medical device compliance

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan

The market for medical devices in Japan is pretty huge. It ranks third in the world after the US and the EU. At just over $ 35 billion a year, which is characterized by an annual growth rate of 3-4 percent; it is far bigger than the markets in the neighborhood, such as China, Malaysia, Singapore and even Australia. Its market for medical devices is comparable to those of Europe and North America. Some of the reasons for this huge market are:

• The aging population
• The huge spending power of one of the world’s largest economies
• The infusion of new technologies into the field of medical devices, which pushes up costs initially
• The high proportion -nearly a quarter of the entire market -of imported medical devices, especially from the US, which introduce sophisticated, technology-driven products of higher price into the market

Japan’s classification system of medical devices, which classifies these products into Class I, Class II, Class III and Class IV; varies from that of the US or the EU. Adherence to Japanese Industrial Standards, which define industry-wide safety and performance requirements, is mandatory for medical devices.
In addition, the Japanese medical devices market has been undergoing a few major changes. Medical device manufacturers have to deal with strict new package insert requirements. The Marketing Authorization Holder (MAH) system, which deals with licensing rules, have changed, requiring a new MAH License category for In Vitro Diagnostic (IVD) devices. New changes have been made into several other aspects of medical devices. These include:

• The registration system for manufacturers
• QMS conformity assessment system
• Formats for pre-market certification and pre-market approval applications

Medical device manufacturers have to also reckon with expanded scope of third party certifications, and comply with rules for Software as a Medical Device and for transferring pre-market certifications.
Full explanation of the regulatory requirements 

All these factors make it very important for medical devices that want to enter the Japanese market, to get a thorough understanding of the regulatory requirements. Complete understanding of all these and more will be imparted at a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.
David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry; will be the Director of this seminar. David carries an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance arenas.

Please log on to Regulatory Filing Requirements and Compliance Processes for medical devices in Japan to enroll for this highly valuable training session which will put the whole gamut of regulatory requirements for medical devices in Japan in perspective. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Understanding how to streamline the regulatory process

By attending this seminar, participants will be able to get a proper grasp of the entire registration and approval process in Japan. They will be able to identify and understand the major changes to medical device registration process in Japan. This will help them to streamline the medical device registration process, which will help them to obtain approval for their product in the most cost-effective and timely manner.

At this highly interactive session, the Director will let participants discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions. This will be a very hands-on approach to helping them to review and discuss pain points, challenges and solutions.
David will cover the following areas at this seminar:

• Which regulatory bodies in the Japanese government are responsible for medical device registration in Japan?
• In Japan, are medical devices required to be registered before they can be sold?
• What are the different regulatory classifications for medical devices?
• What are the different application categories for medical device registration?
• What does the registration pathway look like for each regulatory classification?
• What are the document requirements for notification for the various classes of medical devices?
• What are other requirements that are necessary for approval in addition to the device application?
• Is local testing (type testing/sample testing) required for registration?
• When are clinical studies required for registration?
• Is approval in the Country of Origin required for registration?

To join us for more information, get in touch

Effective legal writing skills are essential for FDA submissions

A number of reasons make cultivation of the art of effective legal writing skills for FDA submissions important. Documents that are submitted to the FDA are deeply technical in nature, because of which they make heavy reading. Being the product of studiously and meticulously carried out research and finding, these submissions are very scientific and technical. Mastering the art of making legal writing effective and embellishing it is necessary for those who make FDA submissions because this can make these documents lucid and pleasant.
It is the habit of most law schools to prepare future attorneys by teaching them the art of summarizing and sharpening intricate and heavy textual and academic matter into crisp, concise and credible arguments. It is in situations such as drafting responses and applications to FDA that these kinds of writing skills become vital. The FDA expects responses to their queries, or for that matter, any poser that requires a response, to be very exact, scientific and technical. So, developing the art of effective legal writing skills for FDA submissions is a big need for those who prepare legal documentations.
Ridding submission documents of heavy text

Making submissions about the product apart; effective legal writing skills for FDA submissions need to be developed for another important reason. Companies have to paddle through a muddle of legally heavy, often confusing regulations, which are legally binding requirements that are based upon statutory laws and judicial opinions.
Professionals in the pharmaceutical and medical device companies are required to handle these and respond to these at the appropriate times. A firm grasp of the requirements for doing this is needed for clearly understanding how to frame persuasive arguments and to negotiate with the FDA.
Effective legal writing skills can contribute to success in FDA submissions

Effective legal writing skills for FDA submissions can stand between the success and failure of many new drugs, biologic or medical device projects, because a document that is confusing and is laden with incomprehensible jargon confuses the regulatory authorities and could become a reason for rejection of the submission.
This is why the more persuasive and articulate these arguments; the greater the chances for the company’s products of getting approvals from the FDA. All these facts make the cultivation of effective legal writing skills for FDA submissions extremely important.
Major learning on effective legal writing skills for FDA submissions

The ways of making legal writing skills effective for FDA submissions will be the topic of a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing.
The Director of this highly important and rewarding session on legal writing skills for FDA submissions is Robert Michalik, a Massachusetts regulatory attorney and founder of RegulatoryPro.com.  In order to get clarity on how to develop the right tools needed for effective legal writing skills for FDA submissions, please register for this webinar by just visiting Effective legal writing skills are essential for FDA submissions
Effective legal writing skills for FDA submissions improve the chances of success

At this very valuable webinar on effective legal writing skills for FDA submissions, Robert will familiarize participants with the legal writing skills and practical techniques that will enhance their chances for success. Good regulatory writing may help to meet FDA branch-level requirements; but effective submissions that are laced with effective legal writing skills for FDA submissions can withstand scrutiny at the FDA Division level.
The seminar will be highly useful to any person working in Regulatory Affairs or Quality Management who is responsible for summarizing data and technical results, obtaining regulatory clearance or approval of a product, and selling or marketing regulated products. These include Regulatory Affairs professionals, Quality Assurance professionals, Marketing professionals, Scientific and Engineering/Product Development Managers, and Consultants to any regulated industry.
At this webinar, Michalik will cover the following areas:

• Basic communications skills that all successful attorneys use to win arguments, in legal briefs and oral presentations
• Step-by-step analysis of how to present both good and poor data in a persuasive manner
• How to train scientists and engineers to generate “good” data to support legal, regulatory and quality claims?
• Tips and secrets to framing an argument that makes even poor data look good
• Examples of good writing that can be useful templates for training and skills development
• What you should never say in a quality or regulatory document.

Implementing the 510 (K) correctly in compliance with the latest proposed FDA changes

A 510(K) is a premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective, meaning that which is substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA).

There are three types of Premarket Notification 510(K)’s that may be submitted to FDA: Traditional, Special, and Abbreviated. Product modifications that could significantly affect safety and effectiveness are subject to 510(K) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance with 21 CFR 820.30 Design Controls. The FDA provides guidance on these.

Needed: A thorough understanding of these aspects and the FDA’s latest proposed changes

In accordance with the concern evinced by many industry groups and associations, the FDA introduced as many as 60 proposals in August 2010, into the manner in which the 510 (K) process could be expedited. This was done with the intention of accelerating the speed at which newly approved medical devices could be made available to patients across the country. However, with the number of proposals being too many and their scope being too wide; the medical industry suggested that the FDA select for implementation only those proposals that enjoyed the broad consensus of the stakeholders, such as increased reviewer training, development of specific and relevant guidance documents, and enhancements or improvements to the de novo review pathway, among other suggestions.

An upcoming seminar by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance industries, will clarify on these areas taken up for immediate change by the FDA and place them in the right context. It will address key resources when making critical decisions. This seminar will offer important insights into the core areas of premarket notifications, as well as the Design Control requirements under QS regulations and Design Controls.

To enroll for this seminar, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900527SEMINAR.

The Director at this seminar is David R. Dills, a senior Regulatory Affairs & Compliance Consultant. David provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems.

An understanding of the core elements of the PMA

At this seminar, David will help participants understand how medical device manufacturers can locate a "predicate" device and go through the content and format of the 510(K), and offer an understanding of the De Novo process and the expectations for possibly marketing a low risk device, and the potential impact of FDA's proposed changes to the 510(K) process and why manufacturers need to pay attention to these.

He will also offer understanding of all the crucial aspects of the PMA, such as the differences between the Traditional, Special and Abbreviated submissions, an understanding of the Substantial Equivalence and how it is applied, who is required to submit the application to FDA, where to submit the 510(K) and what to expect with the review and approval process, when a device company requires this process and when it does not, the applicable exemptions to the submission process and special considerations, and so on.

Comprehensive risk management is a must for medical device software

Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons:

    1.      Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products impossible;

    2.      Since most activities are closely linked to the development lifecycle; almost none of it can be retrospectively performed. This renders all activities performed till the identification of gaps useless and redundant; making it necessary to start from the beginning, no matter at what stage an anomaly is discovered.

Embedding software risk management into the bigger scope of overall risk management is the way forward if these fiascos have to be avoided.

Learn the ways of doing it right from start till finish 

The proper ways of how to take all the necessary steps for designing, implementing and testing critical medical device software in a regulatory compliant environment will be the learning a two-day, live seminar being organized by GlobalCompliancePanel, a very respected provider of professional trainings for the regulatory compliance areas will impart.

Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, will be the course Director. To participate in this very important seminar, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900683SEMINAR.

In line with globally applicable standard requirements

International consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, has led to risk management being a mandatory component of almost any activity in the medical device industry. This course will explain these requirements.

Given that software risk management has to be embedded into the bigger scope of overall risk management; Markus will introduce all the steps necessary to design, implement and test critical medical device software in a regulatory compliant environment while adhering to the principles of risk management. In addition, he will also address the system level risk management and the resulting interfaces to software.

Understanding safety assurance cases

The 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place to comprehensively summarize all risk related activities and to demonstrate the safe properties of a device. Currently only required for FDA infusion pump submissions; this documentation will most likely become mandatory for all devices. This course will introduce the basic concepts and content of safety assurance cases and will illustrate their usefulness for internal and external review of safety related information.

This seminar will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. It will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. The concept of an assurance case will be introduced to make the combined effort towards designing, implementing and verifying a safe device transparent. The outcome of this learning is that it will help to comply with regulatory requirements with minimized overhead and resource burden.

      

Tools and Methodologies to Predict and Improve Product Reliability

Improving product reliability may be the primary objective of reliability analysis; yet, there are many possible reasons for collecting and analyzing reliability data. There are many examples of collecting and analyzing reliability data. This could be done to assess product reliability in the field. It could be to predict product warranty costs. It could be for estimating replacement part/spares requirements.

Other examples of collecting and analyzing reliability data include:

o   To assess the effect of a proposed design change

o   To demonstrate product reliability to customers or government agencies

o   To compare components from multiple suppliers

o   To compare components from different production periods, operating environments, or materials

o   For improving reliability through the use of laboratory experiments.

Methodologies for doing these

There is a certain overall methodology for setting reliability targets, estimating product reliability from test data and/or field data, and determining whether or not reliability targets are achieved. The intricacies of this methodology will be the content of a two-day, in person live seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas.

Steve Wachs, who is currently a Principal Statistician at Integral Concepts, Inc., brings over 25 years of wide-ranging industry experience in both technical and management positions. To derive the benefit of hearing this experienced professional, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900409SEMINAR to register. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Calculating sample sizes

Steve will discuss the methods for estimating the reliability of subsystems and systems. He will also show how to calculate sample sizes for reliability testing and utilize reliability models to develop forecasts of future failures (e.g. warranty forecasts).

This course will immensely benefit anyone with an interest in product quality and reliability, such as Product Engineers, Reliability Engineers, Design Engineers, Quality Engineers, Quality Assurance Managers, Project/Program Managers, or Manufacturing Personnel.

Steve will help participants with the following:

o   Understand reliability concepts and unique aspects of reliability data

o   Understand underlying probability and statistical concepts for reliability analysis

o   Develop competency in the modeling and analysis of time-to-failure data

o   Understand reliability metrics and how to estimate and report them

o   Estimate reliability of subsystems and systems

o   Determine if reliability specifications are met (at specified confidence level) or whether design improvements are required

o   Develop competency in the planning of reliability tests (excluding ALT)

o   Analyze existing warranty data to predict future returns

o   Develop awareness of more advanced topics in Reliability

New Way of Exploring Economic Environment

Lineament analysis in geological exploration

The existence of efficient and cost-effective methods that help to identify prospective targets that are related to or are influenced by tectonic structures is not common knowledge among professionals in the field of geological exploration.

The right sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of the mineral deposit evaluation process to achieve the best possible confidence in resultant mineral resource and reserve estimates.

Getting Quality Assurance and Quality Control procedures and protocols right is crucial

Accurate and proper QA and QC procedures and protocols are essential to ensure that data collected and created by the mining organization is of a high level of quality and is in compliance with CIM Standards and Guidelines. Geological quality control procedures are meant to monitor precision and accuracy of the assay data, as well as possible sample contamination during sample preparation and assaying. The quality of the data used determines the quality of an estimate.

To offer a complete understanding of this concept, GlobalCompliancePanel, a reputable provider of professional trainings for all areas of regulatory compliance, will be organizing a two-day, live seminar. Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900719SEMINAR?new-economic-environment-Boston-MA.

The Director of this seminar, Ricardo Valls, will introduce to the participants a methodology that will help them to concentrate their exploration efforts even over new areas with limited or nonexistent geological information, while keeping their budget in check.

The centrality of QA&QC procedures

Ricardo will explain how lineament and satellite interpretation are a way to define where to concentrate exploration efforts, as well as how to implement QA&QC procedures to guarantee the quality of the collected data. This is necessary, considering that compliance with the industry-established QA/QC is no longer an option, but a necessity for all the companies to implement, especially those that trade in the markets. Quality assurance is essentially the management system that operates to ensure credible results. The prime objective of the field QA program is to maximize accuracy by reducing introduced variability.

The learning will be gleaned from a quality assurance program that the Director has implemented for the field sampling procedures. This includes collection, labeling, and shipping components. The quality control component of this system is a set of activities intended to control the quality of the data from collection through to analysis. It consists of day-to-day activities such as:

o   The adherence to written protocols; up-to-date and suitable training of personnel

o   The use of reliable laboratories with excellent QA&QC systems in place

o   The regular use of quality control (QC) samples (blanks, standard samples, and field duplicates)

o   Diligent record keeping.

Ricardo will cover the following areas at this seminar:

o   History of the problem, why we need to change the current approach

o   Lineament analysis

o   Lineament analysis and satellite interpretation of data

o   Physical modeling (3D strain analysis and 3D stress analysis)

o   Statistical procedures (Compositional data analysis, correlation analysis, principal component and other methods)

o   Defining a QA/QC program, Blanks, duplicates, standards, external controls

o   Procedures and audits

o   Rock naming in the field

o   Conclusions and recommendations.

Comprehensive risk management is a must for medical device software

Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons:

    1.      Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products impossible;

    2.      Since most activities are closely linked to the development lifecycle; almost none of it can be retrospectively performed. This renders all activities performed till the identification of gaps useless and redundant; making it necessary to start from the beginning, no matter at what stage an anomaly is discovered.

Embedding software risk management into the bigger scope of overall risk management is the way forward if these fiascos have to be avoided.

Learn the ways of doing it right from start till finish

The proper ways of how to take all the necessary steps for designing, implementing and testing critical medical device software in a regulatory compliant environment will be the learning a two-day, live seminar being organized by GlobalCompliancePanel, a very respected provider of professional trainings for the regulatory compliance areas.

Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, will be the course Director. To participate in this very important seminar, please log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900681SEMINAR?risk-management-medical-devices-Boston-MA.

In line with globally applicable standard requirements

International consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, has led to risk management being a mandatory component of almost any activity in the medical device industry. This course will explain these requirements.

Given that software risk management has to be embedded into the bigger scope of overall risk management; Markus will introduce all the steps necessary to design, implement and test critical medical device software in a regulatory compliant environment while adhering to the principles of risk management. In addition, he will also address the system level risk management and the resulting interfaces to software.

Understanding safety assurance cases

The 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place to comprehensively summarize all risk related activities and to demonstrate the safe properties of a device. Currently only required for FDA infusion pump submissions; this documentation will most likely become mandatory for all devices. This course will introduce the basic concepts and content of safety assurance cases and will illustrate their usefulness for internal and external review of safety related information.

This seminar will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. It will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. The concept of an assurance case will be introduced to make the combined effort towards designing, implementing and verifying a safe device transparent. The outcome of this learning is that it will help to comply with regulatory requirements with minimized overhead and resource burden. 

Understanding supplier management for medical devices

The problem with a supplier management program lies in the fact that the FDA audits suppliers only for finished devices. Because of this, manufacturers need to have a high degree of control over them. So, where is the problem? It lies in the FDA’s interpretation of these expectations. This keeps changing from time to time. Over the past five years, these expectations have changed considerably. Manufacturers whose devices have been around for more than five years need to thus make substantial changes into their cGMPs, hence the emphasis on the ‘c’, meaning “current”.  

A seminar from the guru of supplier management

The underlying principles of supplier management will be the basis for a two-day seminar that is being organized by GlobalCompliancePanel, a reputable provider of professional trainings for the areas of regulatory compliance. The Director of this course, Betty Lane, who is the founder and President of Be Quality Associates, LLC, a consulting company that helps small and medium sized medical device and diagnostic companies implement and improve their Quality Systems, will be the Director of this seminar.

To enroll for this very valuable learning session, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900595SEMINAR?medical-device-manufacturers-Switzerland. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Analogous to the FDA’s thinking, European Notified Bodies also periodically update their expectations. Suppliers are now expected to remain current with a guidance document published by the Notified Body Operations Group (NBOG). This seminar will explore 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 by expanding on them to cover other issues and techniques important in effective implementation.

Tools, templates and methods of supplier management

Betty will familiarize participants with the nitty gritty of supplier management by building upon it with the tools, templates, and methods needed for implementing an effective and efficient supplier management program. These tools consist of practical exercises which the Director will get the participants to perform.

She will also use FDA Warning Letters to illustrate the points and help the participants 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. These practical steps are aimed at fortifying and reinforcing their understanding of the topic. It will also offer the kind of interactivity with which the participants can understand the concepts threadbare.

The insight the Director will be offering into the area of supplier management will be the highlight of this seminar. This has been accumulated over years and years of experience that the Director has gained in the area of supplier management in medical devices. The Director will detail and examine the concept of risk from the perspective of both the supplier and the regulatory bodies with depth and clarity. She will also review requirements and expectations of the FDA and European Notified Bodies for supplier management, and then show how to incorporate these into the participants’ own supplier management process. 

Developing Documents and Records to meet the Requirement of ISO 17025

The major challenge for most laboratories is having to develop and implement a functional Quality Management System (QMS) that not only complies with the management and technical requirements of the ISO/IEC 17025:2005 standard, but also meets the laboratory’s needs. This is why QMS is considered the soul of the ISO/IEC 17025:2005 standard.

A highly meaningful and valuable learning session on how to accomplish this is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. The Director at this two-day seminar is Michael Brodsky, President of Brodsky Consultants and a Past President of the Ontario Food Protection Association (OFPA), The International Association for Food Protection (IAFP) and AOAC International. To enroll for this seminar, please log on to    http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900445SEMINAR?developing-documents-records-SFO. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.       

Compliance with ISO is a core requirement

A QMS that complies with the management and technical requirements of the ISO/IEC 17025:2005 standard is the core criterion for accreditation, as well as the backbone of this standard. Michael will familiarize participants with how with how laboratories can accomplish this in depth.

The Quality System Manual (QMS) is indispensable in a QMS environment because, much like its predecessor –Good Laboratory Practice (GLP) –it contains the policies that the laboratory is expected to follow to achieve Quality results. However, it is only the “what to do” component of a QMS. What laboratories also need are the “how to do it” or procedures and methods, and equally importantly, the controls or evidence that it was done properly. These are the critical requirements that documentation has to address, and are what this seminar will cover.

Doesn't end with accreditation

Achieving accreditation is only half the job done, because once this has been done, the tougher part –that of maintaining the QMS –begins. The high number of non-conformances cited during the subsequent biannual audits is proof of this fact. This seminar will explain how to maintain the QMS in the long run to the satisfaction of regulatory authorities, as well as to meet the laboratory’s needs.

Those in Laboratory Management/Supervision, Laboratory Quality Development, Laboratory Quality Management,  Laboratory Quality Control and Analytical support need to ask critical questions at the time of embarking on the process of developing documents and records that meet the requirements of ISO 17025, such as:

o        Why should we want to become accredited?

o        Where do we start?

If our laboratory is already accredited, how do we ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits?

Michael will help participants at this seminar develop the critical thinking that is essential for developing documents and records in compliance with ISO 17025.