200+ followers. WOWWWWWW…

followed- 200

Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

Get more articlehttps://www.globalcompliancepanel.com/freeresources/resource-directory

Please follow us on

Facebook – https://www.facebook.com/TrainingsAtGlobalCompliancePanel

Twitter – https://twitter.com/gcpanel

LinkedIn – https://www.linkedin.com/company/10519587/admin/updates/

Unravelling the DHF, Technical File and Design Dossier

Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU’s regulatory body, the MDD.

The Design History File

The history of the Design History File is an interesting one. It evolved out of the FDA’s realization, over time and experience; that the major part of a device’s problems was happening during the design stage and change phases, regardless of whether it was a new product or a changed one. This led to the birth of the concept of Design Control, aimed at tracking, monitoring and correcting the design elements at every stage from start to finish.

cgmpForCombinationProducts

Outstanding characteristics of the Design History File

cgmpForCombinationProducts

What should the Design History File contain?

The DHF should contain the following:

cgmpForCombinationProducts

Now, the Technical File and Design Dossier

In short and simple terms, one can understand the Technical File and the Design Dossier as the EU’s version of the Design Control and the DHF. In other words, what Design Control and Design History File are for the FDA; the Technical File and Medical Device (MDD) are for the Medical Device Directive.

What should the TF and DD contain?

These files should have all the basic sections needed to support the requirements of the Medical Device Directive (MDD), Essential Requirements (for that product), and the company’s “Declaration of Conformity” for that product:

  • General Information/Product Description/EC Authorized Representative
  • Classification Determination
  • Essential Requirements
  • Risk Analysis
  • Labeling
  • Product Specifications
  • Design Control
  • Clinical Evaluation
  • System Test Reports
  • Functional Bench Testing
  • Lab Testing
  • Sterilization validation (or AAMI TIR 28 Analysis)
  • Packaging Qualifications
  • Manufacturing
  • Sterilization
  • Conclusion
  • Declaration of Conformity
  • Appendix

Differences between the Technical File and Design Dossier

At a broad level, in general terms, while the Technical File is for MDD Class I and Class II a or II b; the Design Dossier is for MDD Class III devices

While Technical Files are retained in the premises of the manufacturer or the Authorized Representative for review of the Competent Authorities or/and Notified Body; Design Dossiers need to be submitted to the Notified Body for review before the product gets its CE-marking.

 

click to continue reading

 

 

Design Control for Medical Devices

Design Control for Medical Devices 3

Design Control for medical devices is of utmost importance to the medical device industry. In order to get a grasp of its importance, one needs to get an understanding of what Design Control is. In simple terms, Design Control for medical devices is a set of logical and linear steps that medical device manufacturers have to take to ensure that:

  1. The medical device being manufactured is safe
  2. The medical device manufacturer follows all the steps and procedures for ensuring that the device it develops is what was meant to be developed
  3. Design controls for medical devices have to be put in place to ensure that the final product – the medical device – meets all the required and prescribed regulatory procedures and guidelines and meets the customer’s expectation

In short and simple terms, design controls for medical devices are verifiable and provable assurances that medical device manufacturers have taken adequate steps to guarantee that a medical device meets its set of required standards and procedures to ensure its safety and meet customer requirements.

FDA and ISO expectations of design controls for medical devicesBoth the FDA and the ISO have regulatory requirements from medical devices that expect some Design Control standards. The FDA’s requirements for design controls for medical devices are spelt out in FDA 21 CFR 820.30, while ISO 13485 is the standard for design controls for medical devices. Although formed by different regulatory or standards bodies; both the FDA 21 CFR 820.30 and the ISO 13485 are essentially similar. Their purview of the areas of design controls for medical devices is almost identically similar to each other. Sections of the FDA 21 CFR 820.30 and the ISO 13485 speak of requirements relating to the following in their various sections:

In just one area of design controls for medical devices, namely Design History File, there is a small difference, in that while the FDA’s regulatory requirements for design controls for medical devices include DHF; in the case of the ISO 13485, this is treated separately.

There is thus near total convergence between the FDA 21 CFR 820.30 and the ISO 13485 when it comes to design controls for medical devices.

Basic requirements of FDA 21 CFR 820.30 and ISO 13485Both the FDA 21 CFR 820.30 and the ISO 13485 have expectations for design controls for medical devices. These are the core areas:

designControlForMedicalDevices

What are the potential areas of risk management?

 

What are the potential areas of risk management.jpgThe most critical aspect of risk management is the identification of potential areas of risk management. This helps the organization to stay focused on the areas in which it could possibly face risks, rather than taking an aimless view and shooting about in the dark.

In a very broad sense, the potential areas of risk management include all areas of a business, because simply no area of the business is exempt from a risk. Talk about finance, and it comes with a risk. What about manufacturing? And what about operations or marketing? How about human resources? In this very expansive sense, every area or activity of the business is among the potential areas of risk management.

Potential areas of risk management could lie simply anywhere

potential-areas-of-risk-managementOn top of these potential areas of risk management that each part of the business is prone to; there are also the other industry-related risks that inhere into any business. The risks of running, say, a firecracker business, are much higher than running a grocery store. So, potential areas of risk management should ideally include a very broad discussion on every aspect of risk management.

However, when one takes an overview of the potential areas of risk management instead of trying to break down the elements of each function in which there are potential areas of risk management; one can classify these among them:

Generic risks: As we have been discussing, any business, absolutely any business, comes with some degree of risk. And, each business comes with its own generic risk, such as falling short of funding at crunch times, core people leaving the organization at important times, logistics failures at critical times, and so on.

potential-areas-of-risk-managementProduct specific risks: As the title suggests, this kind of risk is specific to the product that the business deals with. Some products come with their unique risks, and hence, this kind of risk counts among the potential areas of risk management.

People-specific risks: These can happen in a business in which much depends on a few important people. The inefficiency or departure of such people could be among the potential areas of risk management for businesses or projects that are dependent on people.

potential-areas-of-risk-managementFinancial risks: Obviously among the top potential areas of risk management; financial risks come into play when the organization is not able to meet its bottom lines due to a variety of factors. Not getting funds on time, not getting payments from customers on time, not being able to service debts are some of the factors of financial risks.

Technology risks: Technology is a high area of risk, because it keeps changing at a breakneck speed. If organizations don’t keep up with the pace, technology risks could count among potential areas of risk management.

potential-areas-of-risk-managementMarket risks: Market risks are yet another of the potential areas of risk management because most businesses are run on the assumption or speculation that a market is going to grow at a certain rate or pace. If the estimate of this market goes wrong, it affects the business negatively.

Customer risks: The ultimate decider of the business is the customer. If a customer gets irate at a bad product or service and issues bad press, it could become one of the biggest of the potential areas of risk management.

potential-areas-of-risk-managementReal estate risks: For some businesses, especially retail, the location of the business is a major factor. In many instances, the choice of location could often decide the fate of the business. Imagine setting up a high end retail store in the vicinity of a slum. Does that make sense? Yet, even if a business chooses the right location, it could sometimes be forced to relocate due to factors such as legal issues of the property, making this among the potential areas of risk management.

Finally, what needs to be said is that the list above is by no means a comprehensive one. The potential areas of risk management, as we have discussed at the beginning, are simply too many and too fluid and subjective. They could vary from market to market, product to product and business to business. A business that is perceptive about the market has to make the right assessment of the potential areas of risk management before it starts one. It should also be ready to face the potential areas of risk management if it is up against any factor that lies beyond its reach or forecast.

 

click to continue reading

Medicaid platinum, silver for the rest

AR-170829285
Insurance Commissioner Roger Sevigny … Findings of report are “not conclusive.”

CONCORD — The path New Hampshire has taken toward expanding Medicaid is pushing prices up for everyone else who buys health insurance on the Obamacare exchange at healthcare.gov, according to an analysis recently completed for the Insurance Department.

The average medical costs for the newly insured Medicaid patients are 26 percent higher than the non-Medicaid population on the exchange, even though the Medicaid patients are on average younger.

That is in large part because Medicaid patients are getting platinum plans that they use more aggressively because they have no co-pays or deductibles, while those paying some or all of their policy premiums are mostly in silver plans that they use more judiciously, according to the actuarial firm conducting the analysis.

“Generally, when populations are enrolled in plan offerings with low member cost-sharing, utilization of services is greater,” according to the actuaries from Gorman Actuarial who wrote the report. “This is referred to as induced demand.”

Gorman found that the presence of the expanded Medicaid population in the individual market raised average claim costs for the entire market by 14 percent.

The findings, based on 2016 claims data, were presented Monday to a legislative commission studying the future of expanded Medicaid in New Hampshire, which, in its current form, expires at the end of 2018.

One goal of Obamacare was to get more people covered, and part of the strategy was to make it easier to qualify for Medicaid, so-called “expanded Medicaid,” with the federal government paying 100 percent of the additional cost through 2016. Starting in 2017, the match declines slightly each year until it reaches 90 percent in 2020 and remains there, assuming the law is not changed or repealed.

Using the private market

Nineteen states, mostly in the South and Midwest, decided not to expand Medicaid, while New Hampshire was among 31 states and the District of Columbia that added to their Medicaid rolls. New Hampshire and Arkansas decided to use the private insurance market to cover the newly insured.

To qualify for traditional Medicaid in New Hampshire, you had to have low income as measured by federal poverty levels, and have an additional qualifying condition, such as being a parent or caretaker, disabled or pregnant.

The analysis can be viewed below:

With expanded Medicaid, unmarried, childless, able-bodied adults earning up to 138 percent of the federal poverty level could qualify, and in New Hampshire 40,000 took advantage of the opportunity.

But New Hampshire did not put those 40,000 new enrollees into the same traditional Medicaid program that was already serving 100,000 residents through managed care organizations that control costs. Instead, they obtained coverage from one of the companies offering plans on healthcare.gov, mostly the Ambetter plans offered by New Hampshire Healthy Families.

When the program was being designed that way, ostensibly to leverage the private sector instead of growing a government program, conservative groups like Americans for Prosperity warned against blending the new Medicaid customers whose costs are fully covered with customers who face co-pays and deductibles.

“Expanding Medicaid at all was a bad idea,” says Greg Moore, state director with Americans for Prosperity. “Expanding Medicaid in the individual marketplace was a disastrous one, and now we are asking people who are forced to buy health insurance under the Affordable Care Act to subsidize this bad decision.”

Proponents of expanded Medicaid, including the state’s hospitals, health care providers and many in the addiction treatment and recovery community, say the expansion has been an overall plus to the state, particularly in getting insurance for people in need of addiction-related services.

Facing a decision

So the state has to decide what to do about the program, as it sunsets in its current form in a little more than a year. Insurance Commissioner Roger Sevigny said the findings in the Gorman analysis are “not conclusive” on whether expanded Medicaid should continue in its current form in New Hampshire.

“How to best cover this population is a complex question that the New Hampshire Legislature will wrestle with in 2018,” he said. “These are times of unprecedented uncertainty for individual markets in New Hampshire and across the country ­— a factor that compounds the difficulty of the reauthorization question.”

Most New Hampshire residents who have health insurance obtain it through their employer in a group plan. But the state has about 90,000 individuals who buy insurance on the individual market, via healthcare.gov.

Of that 90,000, almost half (40,000) consist of the fully covered, expanded Medicaid population. The other half, about 50,000, consist of individuals who purchased policies on the exchange, many with premium subsidies.

The big question

One of the big questions the state has to face, if it keeps expanded Medicaid at all, is whether or not to keep the newly eligible population in the individual market or put it under traditional Medicaid.

Tyler Brannen, health care policy analyst in the Insurance Department, says the choice is not that obvious. Leaving the Medicaid population with the paying customers increases costs, but losing nearly half the risk pool in the online exchange would come with consequences of its own.

“They have increased claims cost,” says Brannen of the new Medicaid patients, “but in the future, they may be the ones who provide some stability because they may not be the people dropping out because of price increases.”

dsolomon@unionleader.com

Quality by Design using Design of Experiments 2017

The Q8, which is the ICH guidance document on pharmaceutical development, requires a drug product to meet its intended product performance as well as the needs of patients. A drug product is encouraged to adapt a systematic approach for pharmaceutical development in accordance with the steps defined by Quality by Design (QbD) principles, even though the strategy may vary from company to company or from product to product.

The ICH has offered further guidance and policies for explaining the ways by which the QbD approach should be integrated into the pharmaceutical Quality System. Some of these are:

o  Process design

o  Qualification

o  Continued process verification

o  Risk management

o  Validation.

Laxity in implementation is no longer an option

Despite the issuance of guidance on implementation of these requirements; many companies have not yet implemented QbD into their Quality Systems. This will change soon, though. Regulatory agencies have been taking a serious view of non-implementation of these requirements.

The ways in which reviewers will begin to enforce the requirements from these guidance documents have been spelt out in the manual the Chemistry, Manufacturing, and Controls (CMC) reviewers in the Office of Pharmaceutical Science (OPS) released on policies and procedures (MAPP).

The zeal with which the regulatory agencies will enforce compliance with the requirements of the QbD requirements has been emphasized also by the Director of the Center for Drug Evaluation and Research (CDER) at the FDA, who detailed the concept and reiterated the importance of using a QbD approach to pharmaceutical development in a paper he co-authored in The American Association of Pharmaceutical Scientists in May 2014.

Understand the ways of implementing QbD

In the light of the fact that a drug product can no longer afford to relax in its adherence to steps defined by Quality by Design (QbD) principles to adapting a systematic approach for pharmaceutical development; a meaningful and educative two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will show the ways of doing this.

At this seminar, Heath Rushing, who is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, will be the Director. To gain complete insight into how to implement QbD, please register for this seminar by visiting Quality by Design using Design of Experiments. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Complete learning on QbD using DoE

The core purpose of this session is to demonstrate how to integrate those QbD principles into a pharmaceutical Quality System. Towards this end, Heath will focus on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using Design of Experiments (DoE).

He will also take up the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability for detailed description. All concepts are taught within the product Quality System framework defined by requirements in regulatory guidance documents.

A systematic understanding of the process

A QbD approach for pharmaceutical development studies should include a systematic understanding of the process. It should then use this understanding to establish a control strategy as part of a comprehensive quality risk management program. This systematic understanding should include both identification of significant process parameters and determination of a functional relationship (mathematical model) linking these significant process parameters to the critical Quality Attributes (CQAs). Heath will discuss these in depth.

Despite the thrust of this seminar on the use of DoE for QbD; it will integrate multiple aspects of QbD. An understanding of the relevant applied statistics will be offered, which will help participants understand how statistics can be used to help in two foundational requirements of QbD: A) Setting specifications, and B) Analyzing measurement systems.

Important tools for facilitating understanding

This seminar will also offer tools to participants, which will help them to derive value out of their designed experiments. Generating and analyzing both screening and response surface designs for QbD studies, the ways of using this information: best practices on presentation, setting control plans, constructing control charts, and evaluating process capability are among the other constituents of this course. This course uses the point-and-click interface of JMP software for analyses.

Heath will cover the following areas at this seminar:

o  Implement QbD principles from discovery through product discontinuation

o  Apply statistics to set specifications and validate measurement systems (assays)

o  Utilize risk management tools to identify and prioritize potential Critical Process Parameters

o  Identify Critical Process Parameters and develop a functional relationship between those process parameters and your Critical-to-Quality Attributes (CQAs)

o  Establish your design space

o  Develop a control plan as part of a risk management strategy

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

Design of Experiments (DoE) for Process Development and Validation

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

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

DoE in medical devices

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

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

o  Design and development planning

o  Design verification

o  Design validation

o  Design transfer

o  Design changes.

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

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

Jim Wisnowski, who is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, will be the Director at this seminar. In order to gain a full understanding of the principles and application of Design of Experiments for process development and validation; please register for this seminar by visiting Design of Experiments (DoE) for Process Development and Validation

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

All about Design of Experiments for process development and validation

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

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

An explanation of the methods used

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

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

A primer on statistical analysis

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

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

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

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

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

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

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

o  Understand the need for adding center points to a design

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

o  Present results of DOE studies

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