Management for Medical Device Industry

 

A look at these gigantic figures perhaps gives some perspective of the importance of document management for the medical device industry: The US total market for medical devices is valued at over $110 billion annually. It makes up nearly two fifths of the global market, and is expected to grow by over 20 percent by 2016.

While many global players sell into the American market, the over 6500 American medical device companies too, on their part, sell in the US and other markets.

It goes without saying that a market whose products are often complex and play a critical role in sustaining life for patients has to be highly regulated. For products sold in the American market, irrespective of whether they are manufactured domestically or overseas, a slew of regulations exist for a number of activities. Document management for the medical device industry is one of the core areas for which the FDA has regulations.

FDA and other regulations for document management for medical device industryThe FDA and other regulatory bodies have regulations and standards for GxP processes in the medical device industry. These include:

  • Quality System Regulation (QSR), which is outlined in 21 CFR Part 820, Current Good Manufacturing Practices (CGMP)
  • 21 CFR Part 11
  • ISO 13485, which relates to Quality Management System Requirements for medical devices
  • ISO 14971
  • Relevant sections of SOX, and
  • ISO 9000 standards.
What should a document management system for medical devices be like?Ideally, an electronic document management system for the medical device industry should integrate process management and document management in a simple and seamless manner. This is the real purpose of document management for the medical device industry. This document suite should be customizable and configurable. It should serve the following purposes:

  • It should help companies achieve regulatory compliance with required regulatory bodies and standards such as FDA, ISO and other regulations.
  • It should do this by automating and managing GxP processes in an efficient and cost-effective manner.
  • Communication between the functions of the company should be quick and efficient, and should allow access by designated persons.
  • Document management for medical device industry should be designed to ensure quality compliance and help companies enhance the performance of the GxP processes all through the product development lifecycle. The document management system for medical device industry should help companies have control over critical activities such as:
    • Design Control
    • Device history record
    • Mechanism for receiving and addressing complaints
    • A record of the corrective actions the company takes of these complaints
    • Note of nonconformances

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Getting Design of Experiments and Statistical Process Control right for Process Development and Validation

Procedures must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. Why this needs to be done is because the FDA has, in a recent guidance document on Process Validation, assigned the responsibility for reviewing and interpreting DOE and SPC studies to the Quality Unit.

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Going about doing this work requires a practical orientation. It calls for an approach with case studies and examples. A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will provide just this and fulfill this requirement.

Dr. Steven Kuwahara, Founder and Principal, GXP BioTechnology LLC, will be the Director at this two-day session. To enroll for this valuable session, please register by logging on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900701SEMINAR. 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 interactive session

Dr. Kuwahara will offer theoretical information introduced only when necessary to understand an experiment. A highly interactive and practical session; this seminar offers examples from real processes and testing procedures and present the participants with examples that will be directly applicable to their work.

For any pharmaceutical worker who performs, supervises or reviews manufacturing or testing processes, an understanding of the relationships among the process parameters and the ability to monitor the performance of processes and test methods are necessary. This is all the truer of the worker in Quality Control and Quality Assurance in view of the recent FDA guidance document on Process Validation.

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This work, however, is done by the development, manufacturing, or quality systems worker. So, synchrony between these two levels of employees is needed. This course will equip these two levels of employees with the knowledge of how to design the systems and studies, and interpret the results generated.

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).

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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.

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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.

Making sense of the FDA’s GMP and Regulatory Expectations for Early IND Products

The FDA’s recent guidance documents covering GMP requirements for Phase I products have considerably reduced some of the complexities early phase products face. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.

Although these new guidelines appear to remove the need to follow GMPs for Phase I products; the same still exists in the Food, Drug, and Cosmetic Act. As a result, the need for GMP requirements for Phase I products has not been done away with; rather, it has been altered. Now, the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

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Get trained to understand these aspects

GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day seminar to help Directors, Managers and Supervisors in Regulatory Affairs, Quality Assurance and Quality Control get a grasp of these aspects. To enroll for this highly valuable training, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900695SEMINAR?GMP-regulatory-expectations-San-Diego. Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will be the Director of this webinar.

Advice on the GMP guidance document

This presentation, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion, will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. In one source, it will present the regulations and guidelines that apply to early phase products. In some cases these may not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. Steven will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.

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This course is very useful for any pharmaceutical personnel who must deal with products both in early and later phases of development, as it will make them aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have altered the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time, some of the things that may appear to have changed, have not, and personnel in the pharmaceutical sector should be aware of this. This is the learning that Steven will emphasize at this seminar.

It will cover the following areas:

  • Very Early Stages
  • GLP requirements
  • Early Pre-IND Studies
  • Meetings and Preparing for the IND
  • GMPs for Phase 1 IND products
  • Requirements for Phase 2 INDs
  • Preparing for IND Meetings

Think like the FDA to get compliance right

If an organization in an FDA-regulated industry has to show compliance with its systems; the most effective way for it is to think the way the FDA does. This is the right approach to getting its compliance requirements right.

FDA inspections can result in anything going all the way up to Warning Letters, seizures, injunctions, prosecutions, or recalls or consent decrees if serious violations are discovered at inspections. How does one inculcate the FDA line of thinking on compliance? Organizations need to first get an understanding of what the FDA looks for and keep these in compliance.

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The core of all compliance activity is possession and demonstration of control over the company’s Quality System. When an organization shows this using the subsystem approach; it gives the FDA fewer opportunities to cite minor deviations from the quality system regulation. This is the basis to avoid being cited for more serious systemic deviations from the regulation.

Gaining understanding through training

Proper training on these aspects goes a long way in helping organizations steer clear of issues that give an opportunity for the FDA to take these actions. A two-day seminar from GlobalCompliancePanel, a well-known provider of professional trainings in the regulatory compliance area, will be of immense value in helping professionals get a clear idea of how to get their compliance requirements right.

Just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900523 to learn about the ways of getting into the FDA’s line of thinking on compliance. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The Director of this seminar, David Dills, Global Regulatory Affairs & Compliance Consultant, who has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services, will offer a clear understanding of all the critical components of dealing with an FDA inspection, such as:

FDA History, Inspectional Strategy and Techniques

  • SOPs
  • Training
  • Audits
  • Managing the Inspection and State of Readiness
  • Responding to FDA Inspectional Observations (483s)/Warning Letters
  • Mock Inspections
  • Compliance Program 7356.002, Drug Manufacturing Inspections and other Compliance Programs Device Manufacturing Inspections
  • IOM (Investigations Operations Manual)
  • RPM (Regulatory Procedures Manual)
  • Field Management Directives
  • Inspection Technical Guides and official documents used as reference material for investigators and other FDA personnel

Warning Letter and Notice of Violation Responses/Communicating with FDA

  • Strategy and Remediation Implementation
  • Drafting
  • Liaison with FDA to ensure Close-out
  • Effective Responses

State of Readiness/Practice/Mock Inspections

  • Prepare for “real” inspections by being ready and not caught off guard
  • Practice Sessions and Dress Rehearsals on Day Two

 

Ensuring Drug Supply Chain Integrity is a critical task

Drug supply chain integrity is a means to ensuring that the drug that is consumed by the patient has come through proper sources and is free of adulteration, and reaches the right hands.

The drug supply chain a complex, yet trackable chain that starts from the time the substances and raw materials are identified for their potency and capability for being developed into drugs, and goes all the way up to the consumer and even after.

Drug supply chain is crucial because a weak cog in this link can make the drug spurious and reduce its efficacy. Worse, when drug supply chain integrity is awry, it gives opportunity for the drugs to become illicit and reach the wrong hands, ending up being put to the wrong use.

Dangerous consequences for society at large

This makes the integrity of the drug supply chain a matter of utmost importance to everyone concerned -the medical fraternity, users and their families, the logistics sector, the drug industry, the retail drug sector and everyone else. It is everyone’s duty to ensure drug supply chain integrity.

When the wrong drug (meaning a drug that is not prescribed) is given out to the patient, it accounts for loss of drug supply chain integrity. In many cases, as the ones relating to the massive scale of the recent diversion of sales of the drugs Avastin and Altuzan, the financial loss can be colossal. It was estimated in 2012 that the American economy stands to lose at least a billion dollars a year because of slackness in drug supply chain integrity.

The Prescription Drug Marketing Act of 1987

Legislative efforts to bring about drug supply chain integrity can be traced to the presidency of Ronald Reagan, who passed the prescription drug marketing act (PDMA) of 1987, which sought to regulate the drug supply chain. This was at the peak of the drug threat in the US. It was believed that bringing about drug supply chain integrity could ease the problem.

The NABP-Accredited-Verified Wholesale Distributors Program

This Act gave way to the NABP-Accredited-Verified Wholesale Distributors Program (VAWD), which was passed mainly because the PDMA did not fully succeed in its mission of bringing about the desired levels of drug supply chain integrity. Following the reemergence of spurious drugs in the market in the 2000’s, this program was initiated by the NABP. It strengthens the existing PDMA and seeks to bring about drug supply chain integrity by:

  • Reviewing sections of the existing law and making them stronger
  • Verifying licensures
  • Making more rigorous inspections and checks of facilities

Want to know more? Read:

http://bit.ly/Safety-Reporting-in-Clinical-Trials-San-Diego

http://bit.ly/Predicting-and-Improving-Product-Reliability