Quality audits for the medical device industry

Quality management systems of medical devices have to go through well-defined quality audits. Medical device companies need to implement these in order to show compliance with quality.

ISO 13485 is the quality management standard for medical devices. Based on the process approach of this document and that of 21 CFR part 820 the Global Harmonization Task Force (GHTF) has set out processes for audits relating to the quality management systems of medical devices. The GHTF believes that insertion of quality management system requirements based on ISO 13485 is a first step towards global harmonization of medical devices. These guidelines are meant to lead regulators into articulating regulatory systems for medical devices.

Purpose of quality audits according to GHTF

The GHTF spells out the rationale for carrying out quality audits for the medical device industry. The benefits of carrying these out can be seen in the following:

• Assurance that a high quality medical device will be made available
• Quality audits for the medical device industry make available a harmonized, consistent standard that can be used by future generations
• These audits are independent, verifiable and objective assessment of the manufacturer’s compliance with regulatory requirements
• The results of these audits can serve as an important guide for marketing medical devices.

Definition of quality audit

GHTF describes the quality audit as the organizational responsibilities, processes, structure, resources and procedures taken to implement a quality management system.

What should the quality management system cover?

The QMS in a medical device organization should cover the following:

• Control of documents
• Control of records
• Management review
• Internal audits
• Corrective and preventive action

General requirements for organizations that audit

GHTF lists a few general requirements from auditing organizations. These include:

Audit types

Apart from describing the audit scope and methodology in detail; the GHTF also has a description of the types of quality audits for the medical device industry. They are:

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HIPAA Security Rule Principles

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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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.

 

Outstanding characteristics of the Design History File

What should the Design History File contain?

The DHF should contain the following:

 

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.

 

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Validation of Pharmaceutical Water Systems

Thorough and proper validation of pharmaceutical water systems is highly essential for ensuring that the pharmaceutical unit uses the right quality of water. This is very important, because water is not only the source of life for humans; it enjoys the same importance in pharmaceuticals.

A very important reason for which validation of pharmaceutical water systems is necessary is that water is not only the most widely used raw material or substance in pharmaceuticals; it is also put to a number of uses in the pharmaceutical industry, such as Quality Control, process, production and formulation. Further, water comes with its own set of unique chemical properties that are obtained because of the hydrogen bonds present in it and its polarity. This makes water versatile, since it allows the dissolution, absorption, adsorption or suspension of various different compounds.

Process for pharmaceutical water systems validation

Validation of pharmaceutical water systems is carried out in three phases:

Phase I, which is the investigational phase

Phase II, the short term control phase, and

Phase III, which is the long-term control phase

Pharmaceutical water systems are validated through these three steps or stages to demonstrate and ensure that the facility using pharmaceutical water systems has water under its control and is on the right track for production of the right quality and quantity of water in the short, medium and long terms.

Validation through commissioning and qualificationPharmaceutical water systems validation is carried out through two important steps, namely commissioning and qualification. Commissioning is about putting the validation of pharmaceutical water systems through the required phases using the prerequisite methods of documentation. This documentation is a core part of pharmaceutical water systems validation because it allows for different personnel in the organization to not only keep track of the processes involved, but also make changes when necessary.

Qualification as part of pharmaceutical water systems validationQualification is the next important stage of pharmaceutical water systems validation. Here, before a pharmaceutical water systems validation process is started, the pharmaceutical facility should implement the following important steps:

• Design qualification (DQ)
• Installation qualification (IQ) and
• Operational qualification (OQ)

Phase I:In Phase I, the pharmaceuticals facility samples and tests water sampling for anywhere between two and four weeks for monitoring the water system. If the water system is free of failure during this phase, it is considered a successful phase of pharmaceutical water systems validation.

Phase II:In this phase of pharmaceutical water systems validation too, the water system sample is tested intensively for two to four weeks, during which the water sample should show that it is producing the right quantity of water under conditions of stated SOP.

Phase III:Phase III of pharmaceutical water systems validation is the longest and most arduous period, running to one year after completion of Phase I and Phase II. When the water sample passes through this phase, it is said to have completed the process of pharmaceutical water systems validation and is considered fit for pharmaceutical use.

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What Would Happen to Health Spending Under ACA?

The growth in health care spending is expected to have slowed in 2016 and to remain slow in 2017, due to slower enrollment in government-sponsored Medicaid and a reduction in spending on prescription drugs, according to a report released Wednesday by actuaries from the Centers for Medicare and Medicaid Services.

The report, published in the journal Health Affairs, assumes that President Barack Obama’s health care law, the Affordable Care Act, is still in place. Every year, the Office of the Actuary in the Centers for Medicare and Medicaid Services releases an analysis about how Americans are expected to spend money on health care in the years ahead. The agency will release the final outcomes on 2016 spending at the end of this year, once all the amounts have been tabulated.

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The effects of the Affordable Care Act are expected to dwindle in coming years. The report finds that if the law were to continue as is then the share of the insured population would increase from 90.9 percent in 2015 to 91.5 by 2025, as more people become employed in jobs that provide them with coverage.

The slowing of health spending growth by 1.1 percent to 4.8 percent in 2016 is expected to be short-lived as the U.S. population ages, with baby boomers going onto Medicare and likely needing to use more care. Because of these factors, beginning in 2018 both Medicare and Medicaid are projected to grow faster than private insurance spending as income growth slows.

“Irrespective of any changes in law, it is expected that because of continued cost pressures associated with paying for health care, employers, insurers and other payers will continue to pursue strategies that seek to effectively manage the use and cost of health care goods and services,” Sean Keehan, the study’s first author, said in a statement.

During a press conference in Washington hosted by Health Affairs, Keehan said that “high cost-sharing is certainly one of the important factors” in driving down how much people with private plans use care, given that they have to consider how much they will shoulder costs themselves in the form of out-of-pocket spending and deductibles.

By 2025, actuaries forecast that health care’s share of the economy will reach 19.9 percent, an increase from 17.8 percent in 2025.

According to authors of the Health Affairs article, “medical price growth is projected to quicken in the coming decade compared to recent history, as both overall prices and medical-specific price inflation grow faster.”

In 2014 and 2015, health care spending had accelerated because the Affordable Care Act’s provisions went into effect: Coverage was expanded to more people and more people used health care. The federal government also chipped in more to help people pay for premiums and to pay for Medicaid for low-income Americans. Prescription drug costs also are expected to slow. In 2014 and 2015, spending surged as the drugs that were approved to treat hepatitis C, a liver disease that can require a transplant if it turns into a chronic infection, hit the market.

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By 2016, these effects had slowed. Devin Stone, an economist in for CMS Office of the Actuary, said at the press conference that the projections assume that more drugs will lose their patents, slowing prescription drug costs as more generics become available.

Authors of the projections were forthcoming about the fact that the numbers are likely off target given that future of the Affordable Care Act is mired in uncertainty. Republicans and President Donald Trump have vowed to repeal the law, but lawmakers haven’t yet agreed on the timeline or ways to replace it. Decisions from lawmakers on both sides could alter factors around health spending but could also increase the number of uninsured, despite pledges or efforts not to.

Alan Weil, executive editor for Health Affairs, said the projections were still useful to help inform policy, particularly when it comes to designing ways to respond to the parts of the health care system that are driving price increases.

“This is a baseline and it’s still the law, so knowing where we are going is still important,” he said. “It’s also an important baseline to compare changes to the law. Whether we stick to the law or not, it’s important to know where we would have been.”

 

http://www.usnews.com/news/health-care-news/articles/2017-02-15/without-changes-to-obamacare-heres-what-happens-to-health-care-spending

How to build a complete Safety, Health & Environment Management System through Standards & Practices 2017

 

 

Course “How to build a complete Safety, Health & Environment Management System through Standards & Practices” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Overview:

A management system, by definition, is a process by which a function or functions are carried out in an organization by a series of hierarchal documents that are prescriptive, and set a particular path on which the organization manages its day-to-day operations.

A management system can be for one function, but more often than not, it incorporates many functions. Functions like accounting, engineering, banking, etc. have their own management systems, and the Safety, Health and Environmental, as well as Training and Security should have their own management system. This brings efficiency, consistency, cost effectiveness and timeliness to the entire process.

In order to work effectively, Corporate sets and creates (with business asset) input, the various standards around the functions

The SH&E, plus training and security are the functions we will build the standards and practices around. There are 16 functions that cover the SHE & TS world. We build a standard and practice around all 16 functions. Supporting documents, associated programs, procedures or standard operating procedures (SOP) will be a part of the particular function being managed. The 16 functions that will have a standard and practice specific to the function are:

• Hazard identification & control
• Occupational health & industrial hygiene
• Incident management
• Emergency preparedness
• Environmental
• Regulatory compliance
• Reporting performance
• Managing risk
• Managing safety
• Management security
• Verification & audits
• Document & record management
• Contractor & service provider management
• Competency management (training)
• Commitment, communication and implementation
• Managing change

Why should you attend :

Every organization in today’s business atmosphere, in order to be competitive and in compliance must have a comprehensive management system in place and operating smoothly. For those companies who do not understand this, the going is much harder and very much more expensive.

The standards and practices that are put in place act as the cornerstone for decisions being made relative to resources and dollars spent within the SH&E scope of business.

This process accomplishes the following:

• Identifies the things that need to be managed within the function
• Construct 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
• Build the standard, practice or program so that it can be adjusted according to results
• Build a measuring metric, benchmark or scorecard with both lagging and leading indicators
• Build 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)

 

Areas Covered in the Session:

• How to build a SH&E management system
• How to evaluate its effectiveness
• The tools you need in order to build a SH&E MS
• How to implement the system with total management support
• How to develop successful implementation plans, both with management and the workforce
• How to tell the difference between a standard and a practice
• How to understand how to design SH&E documents correctly
• How to assess the risk of not having a MS process in place
• How to roll the process out
• How to communicate the process to those who can support the effort

 

 

Who will benefit:

• EHS Managers, Directors, VP
• Regulatory Managers
• Compliance Managers
• Production Managers, Directors, VP
• Legal Managers
• Quality Auditors
• Operational Leaders (managers, directors, VP)

 

Agenda:

Lecture 1:

Process overview, Main elements of the SH&E MS, Process, infrastructure & system

Internal sources and External sources

What the regulatory agencies are looking for in a SH&E MS

Lecture 2:

System deficiencies

People, process & tools

Lecture 3:

The law perspective & risk analysis

Managing the risks through a systems approach

Lecture 4:

Non-conformance with expectations

Trending for results

Plan-Do-Check-Act

 

Day 2 Schedule

Lecture 1:

Process mapping tools

Creating the Standards & Practices (lots of examples)

Lecture 2:

Continue creating standards & practices

Lecture 3:

SH&E MS plan execution

Communicating the management system

Lecture 4:

SH&E documentation expectations

The MS review & approval process by management

Auditing the MS

How to roll it out – by stages

 

 

Speaker:

James Thatcher,

President, Global Safety Solutions, LLC,

 

James Thatcher the owner and President of Global Safety Solutions, LLC, headquartered in Divide, Colorado. Dr. Thatcher has 35 years of experience in the Oil and Gas, Metals/Minerals and Chemical industry, with management positions in engineering, operations, human resources, safety, health and environment, as well as training and security.

He has a MS in mechanical engineering, and a Ph.D. in psychology/organizational development. He has had many articles published in the Occupational Hazards Magazine, the VPP Leadership Magazine, IADC driller magazine, and through several organizations such as the National Safety Management Society and the World Safety Organization. He has presented at many seminars, summits, conferences, and association meetings for many years.

He 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. He is recognized in the Safety, Health, Environmental, Training and Security disciplines as an expert in these fields. He was the president of the National Safety Management Society for two terms, and is on their board of directors. He is closely associated with the World Safety Association, and is listed in the United Nations directory as an expert in the field of safety, health, training and security. He was the President of Technical Safety and Training Solutions, Incorporated, and consulted in the United States, Europe and South America.

I offer presentations for EHS conferences and summits, as well as for business group meetings in the area of EHS culture, values, systems, motivation, and inspiration. These messages are both timely and effective in helping to raise the bar in your EHS efforts.

 

 

 

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

 

 

Venue: The DoubleTree Baltimore-BWI Airport

Address: The DoubleTree Baltimore-BWI Airport   890 Elkridge Landing Road – Linthicum, MD 21090

 

Price:

 

Register now and save $200. (Early Bird)

 

Price: $1,295.00 (Seminar Fee for One Delegate)

 

Until February 28, Early Bird Price: $1,295.00 From March 01 to April 04, Regular Price: $1,495.00

 

Register for 5 attendees   Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

 

 

Quick Contact:

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Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Website: http://www.globalcompliancepanel.com

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Article on FDA 21 CFR Part 11 Compliance

FDA-regulated industries electronic signatures and other records are considered authentic. From 2007, a strong body of opinion has emerged challenging the stringency of these requirements, but nothing major has been diluted from these.

The regulations under FDA 21 CFR Part 11 Compliance set out criteria that the Food and Drug Agency (FDA) considers in order to deem electronic signatures authentic. The electronic records, electronic signatures, and handwritten signatures executed to electronic records of several FDA 21 CFR Part 11 Compliance sets out benchmarks by which FDA-regulated industries have to be compliant with the standards set out in FDA 21 CFR Part 11 Compliance to prove that these are authentic, safe and trustworthy. The operative factor is that the FDA has to consider these signatures as being on par with those done on paper.

Which industries are included in FDA 21 CFR Part 11 Compliance?

FDA 21 CFR Part 11 Compliance applies to nearly all FDA-regulated industries, including but not restricted to:

• Medical device manufacturers
• Drug makers
• CROs
• Biotech companies, and
• Biologics developers

The Aim of FDA 21 CFR Part 11 Compliance

The aim of FDA 21 CFR Part 11 Compliance is to ensure that specified FDA-regulated industries such as those mentioned above (with specific exceptions) implement controls -which could include audits, audit trails, documentation, system validations, and electronic signatures -for software and systems involved in processing electronic data that are:

• Required to be maintained by the FDA predicate rules or
• Used to demonstrate compliance to a predicate rule. The FDA describes a predicate rule as any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. FDA 21 CFR Part 11 Compliance also applies to submissions made to the FDA in electronic format, such as a new drug application.

Which industries are exempt from FDA 21 CFR Part 11 Compliance?

Interestingly, exceptions are allowed within the same industry, based on the format of filing. For example, while FDA 21 CFR Part 11 Compliance applies to submissions made to the FDA in electronic format; it does not apply to a paper submission for the same made in electronic format, such as fax.

Also, FDA 21 CFR Part 11 compliance is not required for record retention for trace backs by food manufacturers. Similar to the logic used in the mode of filing as noted above; most food manufacturers are not otherwise explicitly required to keep detailed records, but when organizations keep electronic documentation for HACCP and similar requirements; this documentation must meet these requirements.

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The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD)

The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD) are core regulatory documents for a medical device. This is how one can understand the central difference between them: the Design History File (along with Design Control), is the most important among the regulatory documents that the FDA requires for medical devices, while the Technical File and Design Dossier are documents that serve the same purpose, however, within the EU’s regulatory body, the Medical Device Directive (MDD). These documents constitute core regulatory requirements within these regulatory bodies.

The DHF on the one hand, and the TF and the Design Dossier on the other, have a lot of similarities as well as dissimilarities with each other. At a basic level, the major similarity between them is their intended purpose, while what they should contain is the main difference between the two.

If US medical device companies seeking to go global have to compete at a global level, they must meet an assortment of product design documentation standards. The Design Control and the Design History File (DHF) are mandated by the FDA’s CGMPs in 21 CFR 820.30, while for the EU; the core requirement is its CE-marking documentation –the Technical File or Design Dossier, as described in the MDD.

A thorough understanding of Design History File, the Technical File and the Design Dossier is necessary

All the complexities and in-depth clarification relating to these subtle matters about medical device regulatory requirements will be unraveled at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. John E Lincoln, who is Principal of J. E. Lincoln and Associates LLC, a consulting company and a senior Consultant in the Medical device and Regulatory Affairs areas, will be the Director at this seminar.

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. To register for this seminar, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900746?linkedin-SEO .

Complete knowledge of Design History File, the Technical File and the Design Dossier

At this seminar, Lincoln will examine the existing and proposed requirements for the FDA’s DHF, which includes a discussion of its derivative documents, the DMR and DHR. He will explain what the European Union’s MDD TF/DD requirements are, along with an evaluation of the documents’ differing purposes and goals, their similarities, as well as the two different device classification schemes. All important aspects relating to these areas will be taken up.

These are some of the topics Lincoln will take up for discussion:

o  Areas requiring frequent re-evaluation or update

o  Similarities and differences

o  Future trends

o  Typical DHF Table of Contents

o  Technical File or Design Dossier Table of Contents

o  The importance and usefulness of the “Essential Requirements”

o  Structure of the “Declaration of Conformity”

o  Self-declaring or Notified-Body reviewed

o  Parallel approaches to development

o  The differing approaches to file audits by the U.S. FDA and the EU Notified Body.

Useful session for companies that need to handle Design History File, the Technical File and the Design Dossier

Being a seminar aimed at helping participants understand US and global standards for medical devices; it will offer valuable assistance to all regulated companies that need to implement, review and/or modify their Device History Files, Device Master Records, Device History Records, Technical Files or Design Dossiers, documents, and activities/plan(s).

During the course of these two days, Lincoln will cover the following areas:

o  The Design Control requirements of the CGMPs, 21 CFR 820.30

o  The Design History File – documenting Product Design Control and its nine elements

o  The Device Master Record and the Device History Record

o  The EU’s Medical Device Directive

o  The “Essential Requirements”; and their documentation

o  The remaining elements of a Technical File / Design Dossier

o  Trends

o  Two attendee projects.

Preparing premarket submissions that win regulatory approval

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance.

What makes preparing premarket submissions that win regulatory approval challenging? It is the fact, acknowledged by the FDA itself, that the PMA is the most stringent type of device marketing application required by the FDA. The PMA should be secured from the FDA before the company markets the medical device. The FDA gives its approval of the PMA for a Class II medical device only after it determines that all the elements necessary for assuring that the application has enough scientific confirmation that it is safe and effective for the intended uses it is going to be put to. Preparing premarket submissions thus is an onerous task by any stretch of imagination.

Another element of preparing premarket submissions that win regulatory approval

Another aspect of preparing premarket submissions is the 510 (k). The 510 (k) is essentially a kind of premarket submission that is made to the FDA to show that the device that a manufacturer intends to market is at least as effective and safe as a legally marketed device of its equivalence, already in the market, that is not subject to PMA. The FDA calls this principle the substantial equivalency (SE) and the device that is used as the reference for equivalence, the predicate device. The requirements governing SE are contained in 21 CFR 807.92(a) (3).

On top of all these, regulatory professionals have the responsibility of creating preparing premarket submissions that should not only convincingly demonstrate the ways of stating and explaining regulatory arguments for their device to the U.S. FDA reviewer for getting the approval; they should also be presentable and well-organized, without being cluttered or confusing.

Professional trainings for preparing premarket submissions that win regulatory approval

Given all these, it goes without saying that a completely thorough understanding and knowledge of the relevant U.S. FDA laws, regulations and requirements is absolutely necessary for regulatory professionals. This in-depth understanding can be had only from thorough training, which is indispensable if the medical device company is to win a clearance or approval.

The ways by which to do this is the core learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will impart. The Director of this seminar is Subhash Patel, a very senior regulatory professional and founder of New Jersey-based MD Reg Consulting LLC, which serves medical device industry clients in all aspects of global regulatory affairs specific to their needs.

To enroll for this highly valuable training session on how to successfully prepare 510(k)/Pre-IDE/IDE and PMA premarket submissions that secure clearances and approvals from the FDA, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900776SEMINAR?wordpress-SEO .  This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The grasp needed for preparing premarket submission that win regulatory approval

At this seminar, Patel will demonstrate the grasp that regulatory professionals in the medical devices industry need for working with the FDA officials during the review and approval process of their submission. He will offer a complete understanding of the major aspects of FDA premarket submissions.

While knowledge of the regulatory process is one thing; medical device companies also need to know how to set and state regulatory arguments for their device in a most convincing manner to the FDA reviewer. This knowledge will be part of this course. In the process of explaining how to prepare premarket submissions that win regulatory approval; Patel will also offer tips and suggestions to participants on how to work effectively with the U.S. FDA officials during review and approval process of their submission.

During the course of these two days, Patel will cover the following core elements of how to prepare premarket submissions. He will explain the following:

o  History and background of U.S FDA Laws and Regulations

o  Classify Your Device

o  Choose the Correct Premarket Submission for your device

o  Compile the Appropriate Information for your Premarket Submission

o  Author and Prepare your Premarket Submission

o  Submit your Premarket Submission to the FDA

o  Interact with FDA Staff during Review and Approval

o  Complete the Establishment Registration and Device Listing

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

Applied statistics for scientists and engineers

Applied statistics for scientists and engineers is necessary for a number of reasons. 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries specify the application of statistical methods for these functions:

o  Setting validation criteria and specifications

o  Performing Measurement Systems Analysis (MSA)

o  Conducting stability analysis

o  Using Design of Experiment (DOE) for process development and validation

o  Developing process control charts, and

o  Determining process capability indices.

Since scientists and engineers are at the heart of these functions, they need to have a thorough knowledge of how to use applied statistics. Each of these particular applications requires different and specified statistical methods. The common tools used for setting acceptance criteria and specifications are data and tolerance intervals, while for setting expiries and conducting stability analysis studies; simple linear regression and analysis-of-covariance (ANCOVA) are used.

For analyzing designed experiment for process development and validation studies, two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used, while for developing process control charts and developing process capability indices; descriptive statistics (distribution, summary statistics), run charts, and probability (distributions) are used.

Explaining the importance of applied statistics for scientists and engineers

A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will explain the importance of applied statistics for scientists and engineers.

In the course of making the importance of applied statistics for scientists and engineers known; the Director at this seminar, Heath Rushing, who is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, and has been an invited speaker on applicability of statistics for national and international conferences, will provide instruction on applied statistics for scientists and engineers and statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries.

To enroll for this highly valuable and practical course on applied statistics for scientists and engineers, just register by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900790?wordpress_SEO .

The course “Applied Statistics for Scientists and Engineers” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The tools that help an understanding of applied statistics for scientists and engineers

This course on applied statistics for scientists and engineers will offer thorough instruction on how scientists and engineers need to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building. The Director will present the ways of establishing competence in each of these areas and industry-specific applications.

The application of statistical methods across the product quality lifecycle is specified in the 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries. There are many statistical methods that may be applied to satisfy this portion of the QSR. Yet, some commonly accepted methods can and should be used by all companies to:

o  Develop acceptance criteria

o  Ensure accurate and precise measurement systems

o  Fully characterize manufacturing processes

o  Monitor and control process results and

o  To select an appropriate number of samples.

At this seminar on applied statistics for scientists and engineers, Rushing will provide instruction on all these. He will cover the following areas over the two days of this seminar:

o  Describe and analyze the distribution of data

o  Develop summary statistics

o  Generate and analyze statistical intervals and hypothesis tests to make data-driven decisions

o  Describe the relationship between and among two or more factors or responses

o  Understand issues related to sampling and calculate appropriate sample sizes

o  Use statistical intervals to setting specifications/develop acceptance criteria

o  Use Measurement Systems Analysis (MSA) to estimate variance associated with: repeatability, intermediate precision, and reproducibility

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