Water System Validation in Pharmaceuticals Industry 2017

 

Overview:

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don’t work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn’t recur.

Why should you attend?

Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it.

Who will benefit:

This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the “true” whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are:

• Microbiology Laboratory supervisors and analysts responsible for water sampling and testing
• Quality Assurance personnel responsible for water system deviation management and change control
• Regulatory and Compliance professionals responsible for FDA interactions
• Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation
• Facility Engineers responsible for water system design or renovation
• Validation personnel for water system qualification
• Change Control personnel involved in water system changes and repairs
• Production Managers involved with water system use for manufacturing and cleaning
• Laboratory Managers and Supervisors responsible for lab water systems and other water sources

Agenda:

Day One

Lecture 1:

What Makes Water Systems Have Microbial Quality Problems

• Understand biofilm basics and how it develops
• Understand the impact of biofilm on the commonly used purification unit operations
• Understand how various commonly used microbial control strategies work (or don’t work) to control biofilm development
• Understand the how, where, and why of microbial monitoring, action levels, etc.
• Debunk a few water system myths
• Get answers to your own water system questions

Lecture 2:

Successful Sanitization Approaches for Trouble-Free Water Quality

• Material and construction limitations
• Continuous vs intermittent sanitization
• The importance of biofilm removal
• How sanitants work (or don’t work)
• When to sanitize
• Troubleshooting sanitization problems

Lecture 3:

Water System Validation by Logic Instead of Tradition

• Why validate a water system?
• Basic ground rules for water systems before you validate them
• Micro Test Method “validation”
• Minimum validation expectations
• How to figure out what you should validate
• What happens after the honeymoon is over
• Is validation ever really over?
• Special considerations for lab water systems
• Are packaged waters a viable option?

Lecture 4:

Implementing Changes to a Validated System

• Purpose of a Change Control program – a help, not a hindrance
• When is a change major vs minor, requiring full vs limited re-qualification?
• What about water use during re-qualifications?
• FDA validation expectations
• Reliance on logic and common sense and the disservice of precedent and paradigms
• Additional useful tips

Lecture 5:

Reducing Water Microbial Excursions & Improving Investigations

• What are excursions?
• Water system dilemma: process control or quality control (utility or raw material), or both
• Intended roles of Alert/Action Levels and Specifications
• Investigation, necessary and often fruitless
• Excursion responses and impact
• Criticality of valves, hoses, & outlet flushing
• Diagnosing the source of the problem
• Minimizing unnecessary excursion responses through best practices

Day Two

Lecture 6:

Understanding and Controlling Endotoxin

• Where does endotoxin come from?
• What are the properties of endotoxin?
• How do you get rid of it?
• How do you detect it?
• What assay controls are used?
• What are the endotoxin specs for water?
• How do you control it?

Lecture 7:

Harmonizing vs Optimizing Water Microbial Testing for System Quality Control

• Water harmonization that has occurred
• Water Micro TM “Dis-Harmonization”
• A little about Biofilm
• Biofilm diversity in water systems
• Micro TM options and evaluation protocol
• The good and bad of Micro harmonization
• Where RMMs can fit in
• Parting wisdom

Lecture 8:

Microbial Enumeration Issues with High Purity Water Systems

• Microbial Enumeration Issues with High Purity Water Systems
• Biofilm enumeration issues (planktonic vs surface)
• Traditional cultivative approach issues
• Validation of your test method
• Alternative TM choices (advantages/disadvantages)
• Significance of water isolates
• Sampling issues
• Establishing Alert/Action Levels and Water Specs and defending them to FDA

Lecture 9:

Water System Investigation “How-To’s” and Example Case Studies

• Gathering and assessing existing data and symptoms
• Considering user opinions
• Investigation approach elements
• Recognizing red herrings/false positives
• Recognizing possible root causes
• Water system contamination case studies
• Parting kernels of water system wisdom

Lecture 10:

What USP Does and Doesn’t Say about PW, WFI, Pure Steam and Micro Issues

• PW, WFI, Pure Steam micro specifications?
• <1231> Starting water issues
• <1231> Misunderstood issues clarified
• <1231> Microbiological test issues clarified
• <1231> Suggested micro test method
• <1231> Micro Specifications
• <1231> Alert and Action Levels and max’s
• Recent/Upcoming USP water changes
• Discrepancies between pharmacopeia’s

Speaker:

Teri C. Soli, Ph.D.

Principal Consultant, Soli Pharma Solutions

T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. offering training, auditing, and troubleshooting expertise covering water systems, contamination control, sterilization, aseptic processing, and microbiological laboratories. He has 38 years of pharmaceutical experience as a consultant and with operating companies including DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer.

Dr. Soli’s career-long water systems and contamination troubleshooting, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about process and contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems.

He is beginning his fourth 5 year term on USP Expert Committees responsible for Pharmaceutical Water, previously served 5 years on the Advisory Panel to the USP Microbiology Subcommittee, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide as well as coauthor USP’s comprehensive “water bible’, Chapter <1231> “Water for Pharmaceutical Purposes”. As a recognized global expert in contamination and biofilm control in the pharmaceutical setting and accomplished presenter, Dr. Soli speaks at numerous conferences and webinars. He has authored numerous articles in Pharmacopeial Forum and other publications as well as chapters in books and industry guides published by PDA and ISPE.

Location: Hyderabad, India Date: April 10th & 11th, 2017 and Time: 9:00 AM to 6:00 PM

 

Venue: Taj Banjara

Address: Road No.1, Banjara Hills, Mithila Nagar, Banjara Hills, Hyderabad, Telangana 500034, India

 

Price:

 

Register now and save ₹ 2000. (Early Bird)

 

Price: ₹ 14,000 (Seminar for one Delegate)

 

Until March 15, Early Bird Price: 14,000 from March 16 to April 08, Regular Price: 16,000

Registration Details:

NetZealous – GlobalCompliancePanel

NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,
Bangalore – 560078 Karnataka, INDIA

Phone:  1800 425 9409

Fax:  080-25149544

smanzoor@netzealous.com

http://www.globalcompliancepanel.in/

Registration Link – http://www.globalcompliancepanel.in/control/pharmaceutical-water-systems-Hyderabad?channel=mailer&camp=seminar&AdGroup=wordpress_April_2017_SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanelindia

 

 

 

 

 

Statistics for the Non-Statistician: Is it necessary?

Statistics for the non-statistician: Isn’t this some kind of a contradiction in terms? Why does a non-statistician need to rake his head over statistics? Is statistics a life skill or a lifesaving one? If it is not, why is statistics for the non-statistician necessary? At first glance, statistics for the non-statistician may appear unnecessary and redundant, but a slightly deeper look will make one understand that statistics for the non-statistician is indeed important, and has uses that help to make important contributions to the organization in which they work.

For understanding processes

Statistics for the non-statistician is important because we need statistics in the course of our professions while taking important decisions in business. For those working in the corporate world, statistics for the non-statistician becomes an important tool and skill with which a deeper understanding can be made of the statistical tools and techniques that employees routinely use in an organization. Using these tools, the professional has a greater understanding of the important parameters and pointers of the business and how to bring about improvements in the quality of a firm’s process and product.

Why statistics is important for the non-statistician can also be understood from the fact that when statistics is not properly analyzed, i.e., when statistical analysis is not performed insightfully as a result of a lack of full understanding of the statistical principles and processes by the employees; the organization faces a number of problems. These range from the possibility of facing the risk of producing a poor quality product. Such a product severely retards its ability to deliver a high quality product, as a result of which there is a heavy negative impact on the organization’s bottom line, as well as a blow to its reputation.

Get to understand the importance of statistics for the non-statistician

The importance of statistics for the non-statistician can also be understood from the fact that its knowledge helps regulatory professionals meet regulatory compliance requirements without hassles. To get a clear understanding of the ways in which statistics for the non-statistician helps organizations overcome many challenges, a seminar is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

At this seminar on statistics for the non-statistician, Steven Walfish, the founder and President of Statistical Outsourcing Services, who brings nearly 20 years of industrial experience providing statistical solutions to complex business problems, will be the Director. To enroll for this seminar, please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900742SEMINAR?linkedin_SEO. The “Statistics for the Non-Statistician” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

It is all about practice

Practice is at the root of understanding statistics for the non-statistician. Constant practice is the mantra for employees to attain proficiency in statistics. They need a little bit of initiative, familiarity and some real-world example data sets. Employees who need training on statistics for the non-statistician need an understanding of the most common statistical tools and terms.

They need to understand

a.      how to use statistics to properly trend data

b.     support the annual product review

c.      justify process changes

d.     set product specifications.

The aspects of statistics that employees need to be familiar with

Employees who want to learn how statistics works for the non-statistician need to be able to make use of statistical software packages and understand the role of software in statistical analysis and statistical process control. They also need to have the skills necessary to design a statistically sound sampling plan that helps them comply with FDA APR requirements.

The result of this kind of familiarization is that organizations can perform their core functions and still be in alignment with statistical processes that are necessary for staying ahead of the competition. This is what statistics for the non-statistician entails.

The course on statistics for the non-statistician is immensely useful to professionals and supervisors in medical devices, diagnostics, pharmaceuticals and the biologics fields.

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

Read More :  http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900830SEMINAR?wordpress_SEO

Management systems should be expansive and versatile

Management systems should be expansive and versatile, as having such a system makes sense for organizations. A management system is a mechanism that helps streamline an organization’s day to day functioning without hassles. It should put the organization on the path it chooses to take by putting in place a set of documents that is prescriptive and hierarchical, and well-defined. Although all these processes can be put in place for only one function; it makes better business and economic sense to have a management system that performs and carries out its objectives across a spectrum of functions and activities.

Organizations should ideally build a comprehensive and thorough management system that should be a set of standards and practices that addresses the organization’s safety, health and environment management aspects. A major advantage having such a system brings is that it makes the entire process efficient, consistent, cost effective and timely.

Creating a fulcrum for health and environment management systems

An effective and proven way of making management systems work effectively is for corporations to use the business asset to set and create inputs for the various standards around the functions. The standards and practices that are put in place in such a manner become the basis and edifice on which decisions relative to resources and dollars spent within the Safety, Health & Environment (SH&E) scope of business are made. In other words, a management system works best and most effectively when it becomes a pivot around which a host of functions can be performed.

Safety, health and environment are the core issues of a sound management system. If organizations have to build an SH&E system that is designed along the lines described above; they need to have the ability to properly assess their requirements first. They need to also have the foresight to anticipate the changes that these functions will undergo in the future, and should build a management system that has the robustness, flexibility and resilience to accommodate and ingest these changes. The financial consequences of building a management system that fails to take these factors into consideration are huge.

A management system that takes SH&E into consideration can achieve a lot

This process accomplishes the following:

o  Identifies the things that need to be managed within the function

o  Constructs a process, tool, or mechanism that best manages each of those things identified. They are usually a set of standards, practices and programs that are built specifically for a particular function

o  Builds the standard, practice or program so that it can be adjusted according to results

o  Builds a measuring metric, benchmark or scorecard with both lagging and leading indicators

o  Builds the management system in a way that is hierarchal in structure within the organization – (corporate sets and standards and the business unit builds the practice around the standard)

Trainings for inculcating the mindset for building a strong management system

The principles to adapt and the thinking needed to cultivate the outlook for building such a management system will be the core part of a seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas.

James J. Thatcher, President and Owner, Global Safety Solutions LLC., who is listed as an expert witness for operational as well as safety, health, environmental, training and security issues in the Oil and Gas industry and the mining, minerals and chemical industry; will be the Director at this learning session. Please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900842SEMINAR?wordpress_SEO    to register for this highly valuable learning session.

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

In-depth exploration of SH&E management systems

This seminar will make an in-depth exploration of management systems in the health and environmental areas. James will offer a detailed understanding of SH&E, plus Training and Security (TS), which are the functions around which standards and practices are built. He will describe the 16 functions that cover the SHE & TS world in detail, which will help participants understand ways by which to build a standard and practice around all these 16 functions.

The 16 functions that will have a standard and practice specific to the function are:

o  Hazard identification & control

o  Occupational health & industrial hygiene

o  Incident management

o  Emergency preparedness

o  Environmental

o  Regulatory compliance

o  Reporting performance

o  Managing risk

o  Managing safety

o  Management security

o  Verification & audits

o  Document & record management

o  Contractor & service provider management

o  Competency management (training)

o  Commitment, communication and implementation

o  Managing change

The Director of this seminar will also explain the role of supporting documents, associated programs, procedures or Standard Operating Procedures (SOP) that are a part of the particular function being managed, to enable clear understanding of the topics.

HIPAA survival needs intimate knowledge of the nuances of the law

HIPAA survival is one of the great challenges for a healthcare entity. HIPAA audits are complex, and they need understanding of the jargon and the semantics of the words mentioned in the document to survive. Both the Covered Entity and the Business Associate need to know exactly what to do in order to pass a HIPAA audit. This is all the more important and necessary considering that the federal budget has plans of raising the budget for the OCR in 2017 by about 10% over 2016, reflecting just how serious the OCR is about HIPAA audits.

When one considers that Phase 2 of HIPAA requires compliance with something like 180 areas and allows just 10 days for response; it goes without saying that HIPAA survival is a high priority for Covered Entities and their Business Associates. Moreover, the OCR’s audit protocol clearly states that those entities that are being audited have to furnish the exact documents required and not offer broad references to policy documents.

Being even slightly lax in being prepared for Phase 2 HIPAA audits can lead to difficulties at the audit. So, HIPAA survival entails having to be one’s toes all the time and having all the edges covered and leaving nothing to chance. HIPAA survival is about putting a process in place and overseeing and implementing it with utmost diligence and attentiveness all the time.

Covered Entities and Business Associates are the target of HIPAA audits

So, where do all these place Covered Entities and Business Associates that are the target of HIPAA audits? There is simply no room for complacence. They have to be absolutely on their guard when facing HIPAA audits. HIPAA survival has to be cultivated as a means for this. The more they hard-wire the art of HIPAA survival into their practice, the better.

The ways by which Covered Entities and Business Associates deal with HIPAA survival is the subject of a two-day seminar that GlobalCompliancePanel, a highly popular provider of professional trainings for the areas of regulatory compliance, will be organizing. To enroll for this highly useful and important session on HIPAA survival, jus log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900780SEMINAR?HIPAA-survival-Chicago-IL.

At this seminar, Brian L Tuttle, a senior Compliance Consultant & IT Manager at InGauge Healthcare Solutions, will educate regulatory compliance professionals about how practice managers need to prepare for HIPAA audits. This seminar will address major changes under the Omnibus Rule and any other applicable updates for 2017. Brian will also cover other related, critical areas such as:

o  Texting

o  Email

o  Encryption

o  Medical messaging

o  Voice data, and

o  Risk factors as they relate to IT.

Brian will dispel many of the myths covering this convoluted law. He will discuss the do’s and don’ts of HIPAA survival, and will also cover the critical area of the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures.

During the course of this seminar, Brian will cover the following areas:

o  History of HIPAA

o  HITECH

o  HIPAA Omnibus Rule

o  How to perform a HIPAA Security Risk Assessment

o  What is involved in a Federal audit and how is it conducted

o  Risk factors for a federal audit

o  EHR and HIPAA

o  Business Continuity/Disaster Recovery Planning

o  Business Associates and HIPAA

o  In depth discussions on IT down to the nuts and bolts

o  BYOD

o  Risk factors that can cause an audit (low hanging fruit)

o  New rules which grant states ability to sue citing HIPAA on behalf of a patient

o  New funding measures

https://www.onr.com/blog/hipaa-audits-increase-2016-2017/

Compliance for medical devices is a very expansive area for manufacturers of medical devices

Compliance for medical devices is a very broad and vast topic. When one talks of compliance for medical devices, one needs to keep in mind the various regulations that the FDA has put in place for manufacturers of medical devices to comply with. The FDA requires strict compliance with its laws and requirements because it is charged with the task of ensuring the quality requirements of medical devices, which are a means to ensuring that the medical devices are safe and effective.

The FDA has undertaken the task of ensuring that medical devices, along with select nonmedical devices adhere to regulations pertaining to manufacturing; repackaging, relabeling and/or importing medical devices sold in the US comply with its requirements through its Center for Devices and Radiological Health (CDRH). The requirements for compliance for Class I, II and III medical devices, such as the registration of the establishment, listing of the medical device, 510 (k), premarket approval investigational device exemption (IDE), Quality Systems, GMP, device labeling and device reporting are set out in the various sections of 21 CFR Part 807.

A GlobalCompliancePanel seminar which will cover all the important areas of compliance for medical devices

A seminar that is being organized by GlobalCompliancePanel, a highly reputable provider of professional trainings for the areas of regulatory compliance, will be delving into the details of all that is required for compliance for medical devices. A boot camp of sorts, this seminar, which will cover all the important areas of compliance for medical devices, will have Susanne Manz, Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc. as the speaker.

To enroll for this very valuable seminar, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900834SEMINAR?compliance-boot-camp-Phoenix-AZ . This seminar on compliance for medical devices has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A boot camp to ensure compliance for medical devices

Susanne will help participants from the medical devices industry get a thorough idea of what it takes to ensure compliance for medical devices. She will show ways by which to improve the quality and compliance of medical devices, while at the same time, optimizing costs. This boot camp is a means to building a sound Quality System with which to ensure compliance for medical devices.

An important piece of learning that Susanne will bring into this seminar is how to understand regulatory requirements and translate them into an effective and efficient Quality System. The ways of planning, structuring, and implementing a Quality System that addresses the specific business needs of the participants will be addressed at this seminar.

Means to address issues within a medical device company’s Quality System

In discussing how to create a quality strategy and plans; Susanne will explain some of the methods that need to be put in place for identifying, prioritizing and analyzing risks. She will help explore the capabilities that every medical device company needs to have if it has to ensure quality products and a compliant Quality System.

In this seminar on compliance for medical devices, Susanne will also take up important related items such as continuous improvement, Six Sigma, and Corrective and Preventive Action (CAPA) to address issues within a medical device company’s Quality System. The ways of effectively communicating and escalating risk, as well as monitoring performance and progress, as well as how to kick start the Quality System into avoiding common problems such as MDRs, recalls, 483s, and Warning Letters, will all be covered in this seminar on compliance for medical devices.

Susanne will cover the following areas at this seminar:

o  Quality System Expectations

o  Quality System Structure

o  Strategy and Planning

o  Risk management in your quality system

o  Case for Quality

o  Inspection preparedness and management

o  Monitoring and metrics

o  Creating a quality strategy and plans.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/default.htm

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.

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Regulatory Filing Requirements for medical devices in Japan

 

Japan is the world’s third largest market for medical devices, after the US and Europe. Ironically, many of the world’s medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing through the regulatory maze! The regulatory filing requirements for medical devices in Japan are relatively less complex than those of the US and Europe and other markets.

Regulatory filing requirements for medical devices in Japan start with passing what is called the Pharmaceutical and Medical Device Law (PMDL). To facilitate better understanding of the language and to make regulatory filing requirements for medical devices in Japan easier, the Pharmaceuticals and Medical Devices Agency (PMDA), which is a part of the Ministry of Health, Labor and Welfare (MHLW) issues English language documents.

The “Toroku” registration processThe Japanese system for complying with regulatory filing requirements for medical devices has two different modes for domestic and foreign medical device manufacturers. For Japanese medical device companies, a registration system known as “Toroku”, which is formulated under the PMDL, applies. According to this process, domestic manufacturers whose manufacturing processes are based in Japan have to register their manufacturing facilities with the local authorities at their respective prefectures. For foreign manufacturers, the same have to be registered with the PMDA.

The step-by-step processThis is how the step-by-step process for regulatory filing requirements for medical devices in Japan takes place:

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Dealing with medical device reporting and recalls

Medical device reporting and recalls have enormous benefits for the medical device company and the public if implemented properly. They can prevent use of defective devices and can be an important inoculation against stringent FDA actions.

Medical device reporting and recalls are a major FDA activity. Medical device companies have clear instructions on how to initiate medical device reporting (MDR) and recalls.

What is medical device reporting?

Procedures for medical device reporting are governed by 21 CFR 803, which has details regarding how a medical device company should go about its MDR.

Who have to make MDR?

The FDA deems it mandatory for these entities to report certain types of adverse events and product problems:

For the following entities, MDR is voluntary and is to be done when serious adverse events are detected in the medical devices they use:

• Professionals
• Patients
• Caregivers, and
• Consumers

These categories can also report issues relating to product quality, therapeutic errors and use errors.

What is a recall?

A recall can be either of these:

• When a firm voluntarily removes or corrects an already marketed device that is found by the FDA to be in violation of its governing act on these devices, namely the Federal Food, Drug, and Cosmetic Act. Seizure of a medical device is an example of this kind of action.
• A recall also happens when a firm voluntarily determines, after investigation, that a device is adulterated in some way. An example of this instance is misbranding, when a manufacturer discovers that the device is not fulfilling its intended use.

A recall is important for two reasons:

How does a medical device company report a recall?

Firms have to follow 21 CFR Part 806 when they have to reporting Medical Devices Recalls, as set out by The Center for Devices and Radiological Health. The Center makes it a requirement for a firm to report when the medical device is posing a risk to health. This has to be reported to the FDA District Office in which the firm is located.

Our webinars can help you gain more comprehensive knowledge of this topic and related ones. Click here (link) for details.

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HIPAA Security Rule

Though short in length,HIPAA Security Rule principles are well defined in some areas, but vague in some others, making implementation of these areas difficult.

HIPAA Security Rules are an offshoot of the Privacy Rule. While Privacy Rule concerns itself with Protected Health Information (PHI) in general, the HIPAA Security Rule (SR) concerns itself specifically with electronic Protected Health Information (ePHI). Since it particularly focuses on an element of the Privacy Rule; it is considered a subset of the HIPAA Privacy Rule.

The HIPAA Security Rule seeks to fortify individually identifiable health information with reasonably high levels of technical, administrative and physical safeguards so that these attributes are protected and unauthorized or inappropriate access, use, or disclosure prevented:

• Confidentiality
• Integrity, and
• Availability.

To enable this, the HIPAA Security Rule codifies a few standards and best practices in information technology. In a general sense, the HIPAA Security Rule requires computer systems containing patient health implementation to implement these three safeguards:

• Administrative,
• Physical, and
• Technical.

It has clear definitions of each component relating to its specifications. Some of the terms on which the HIPAA Security Rule is unambiguously clear are:

Challenges associated with implementing HIPAA Security Rule:

Despite the clarity of definitions of a few terms as stated above; the HIPAA security rule is considered complicated by practitioners and participants in the Rule. Although not a very painfully long document in that it runs into only eight pages; because of the high technical nature of its text, it is considered quite complex.

A major requirement that the HIPAA Security Rule imposes is a set of additional organizational requirements, apart from documenting processes that are in tune with the HIPAA Privacy Rule. This is easier said than done, especially for small time providers that have limited technical bandwidth and capabilities, for whom implementing the Privacy Rule itself can be challenging. The solution is to make Health information technology (HIT) resources available for this kind of providers.

Further, this Rule has some ambiguities. For instance, its fundamental requirement is implementation of “necessary safeguards”. There is no unanimity about what this means.

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