US. Customs Import Rules and Export Traps in 2020

You need to have a plan in place and know what you are doing.

FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA’s thinking, negotiate with the FDA and offer anecdotal examples of FDA’s import program curiosities.

Why you have to study:

What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing.

The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new “Automated Commercial Environment” computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port.

When products are refused, you have different options. Some options may cost more than others. For example, your product can be seized and destroyed by the government. You may be fined if you do not act in a timely manner. These are common problems that become prohibitively expensive. You should know how to avoid common problems or at least how to mitigate the cost by using established and effective business planning.

Learn how to deal with common problems, such as returns for repair, importing QC samples, and investigational products

On a positive note, the FDA is implementing the Voluntary Qualification Importer Program under the FDA Food Safety and Modernization Act. One other perk is that FDA offers export certificates, for a modest fee, which may give you a competitive advantage in foreign markets. In some cases, a FDA export certificate is required by foreign governments. Finally, the new EU Medical Device Regulation will change how FDA manages foreign inspections and in your favor.

About the Instructor:

Casper (Cap) Uldriks, owns Encore Insight LLC, which provides consulting services on FDA Law. He brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed.

Register here for full details

Biotech and Pharmaceutical Courses are a gateway to a challenging and flourishing career

Biotech and Pharmaceutical Courses are a gateway to a challenging and flourishing careerWith over four million employed directly or in allied sectors and catering to the world’s largest market and research area, biotech and pharma is a fast growing industry. Its courses are designed to prepare individuals for this giant industry.

Biotech and pharmaceutical courses are much sought after by aspiring professionals in the field of biotech and pharma. This is why:

  • The US is the world’s largest market for pharmaceuticals, as well as being the world leader in biopharmaceutical research
  • Research by Pharmaceutical Research and Manufacturers Association (PhRMA) has revealed that the majority of the world’s research and development (R & D) in pharmaceuticals is conducted by U.S. firms
  • These firms hold the intellectual property (IP) rights on most new medicines.

Huge in every sense

Biotech and Pharmaceutical Courses2

Around 5,000 new medicines with approximately 3,400 compounds are currently being studied in the United States, the longest pipeline in any region in the world. The pharmaceutical industry employs nearly a million people and supports more than three times that number in related and supplementary industries. All these place a high demand on biotech and pharmaceutical courses.

What should those aspiring for courses look for?

Biotech and Pharmaceutical Courses4

Certification is the primary criterion to look out in those seeking a biotech and pharmaceutical courses. Whether it is classroom or online courses that are opted for; certification by a certifying authority should be the determining admission to biotech and pharmaceutical courses.

CFPIE or the Center for Professional Innovation and Education Inc., BioPharma Institute and Center for Professional Advancement (CFPA) are some of the better known providers of certified biotech and pharmaceutical courses. This is a partial list of the areas on which courses are offered by these institutes/centers:

The following tripod of software-related issues forms the IEC 62304:2006’s foundation:

biotechandPharmaceuticalCoursesThese 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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The ISO 13485: 2016

The ISO 134855

The ISO 13485, which is the ISO’s global medical device standard; was upgraded significantly in 2016. This upgrade was carried out primarily to help the standard keep up with the changes that have taken place in the industry in about the decade and a half since the previous standard was brought into effect in 2003. Changes have taken place in a number of key areas of the medical device field, but the most important changes relate to the changes in technology and in relation to the increased importance of risk management at almost all levels in the medical device industry.

The earlier version was based on the ISO 9001:2000 standard, while the new upgrade is based on a later standard, the ISO 9001: 2008. Changes have been carried out into almost all the sections of the new standard, with the most important areas that have been changed including flexibility, the requirements from medical device companies to adhere to regulatory requirements, the inclusion of the risk based approach into the organization’s QMS, medical device filing and documentation, verification and validation, design and development, training, supplier monitoring and so on.

QMS is an important area of change

The ISO 134851

The QMS is the most prominent area in which the new document differs from that of the earlier version. Although the new version is considerably more closely aligned to the FDA’s Quality System Regulations (QSR); there still exist major differences. Not getting a proper grasp of these differences has the potential for creating problems in implementation.

Medical device companies also need to consider the Medical Device Single Audit Program (MDSAP), the mechanism through which the regulatory systems in a few jurisdictions will continue to rely on ISO 13485:2016. In relation to this mechanism, the fundamental difference between the US and the EU is this: the US will participate in MDSAP, but doesn’t expect to change its regulations, while the EU is not going to participate. It has published its own version, EN ISO 13485:2016, and will continue with the existing Notified Body system. however, the EU will promulgate in its own set of new regulations that will replace the directives. These will lead to new regulations, which will be new versions of EN ISO 13485:2016 and EN ISO 14971:2012.

It is crucial for medical device companies to keep track of the changes introduced in ISO 13485:2016, as this is the new standard that they have to comply with. While it is not legally binding to do this; they gain in a number of ways in being compliant with these changes.

Proper and full learning of the ISO 13485:2016

The ISO 134852

Being compliant with the new version requires a clear understanding of the new regulation, the ways in which it has to be implemented, the areas of work that need to be changed, and so on. A seminar being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will explain all these.

At this seminar, the Director is Dan O’Leary, who is the President of Ombu Enterprises, LLC. Dan, who brings more than 30 years’ experience in Quality, Operations and Program Management in regulated industries including aviation, defense, medical devices, and clinical labs, will offer a complete understanding of how the new regulation needs to be implemented.

Please log on to The ISO 13485: 2016 to enroll for this seminar and get the right perspective of how to implement ISO 13485:2016. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Implementation needs to be done quickly

The ISO 13485

The final version of the new ISO 13485:2016 standard is now available for companies to start implementing. The areas into which changes have to be carried out are quite expansive and huge in number. For many companies, the timeframe for implementation is quite short, depending on the expiry date of their current certificate. Dan will help participants overcome this handicap, and will offer practical implementation advice and suggestions to participants.

He will also use exercises and examples to help participants understand the ways of implementing according to the new guidelines and also analyze the implications of the newly revised regulation, in particular, regulatory systems including MDASP and its nonconformity grading system. This seminar will have the following agenda:

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Psychiatric care is postcode lottery, say medical experts

Psychiatric care is postcode lottery, say medical experts

There are not enough NHS psychiatrists in some parts of the UK and more should be recruited to improve care, says the Royal College of Psychiatrists.

In Scotland, there are 10 consultant psychiatrists per 100,000 people – but only eight for the same number in England and Northern Ireland, and just six in Wales.

London’s tally is more than double that of the east of England.

English health ministers said thousands of new posts were already planned.

The government in England recently announced there would be 570 extra consultant psychiatrists by 2020-21.

And the Welsh government said it was committed to improving mental health services in Wales.

But the Royal College of Psychiatrists said there were too few medical students specialising in psychiatry and not enough psychiatrists becoming consultants.

In England, in the past five years, it said there had been a 1.7% increase in psychiatry consultants compared with a 20.2% increase in other consultants across the NHS.

Areas such as London and the north-east of England have more than 11 psychiatrists per 100,000 people but the south-west has six and Yorkshire five.

‘Falling short’

Prof Wendy Burn, President of the Royal College of Psychiatrists, said: “People with a severe mental illness should expect to see a specialist consultant, just as you would for a severe physical illness.

“The huge variation in consultant psychiatrists across the country means reality is increasingly falling short of our expectations.

“As highly skilled medics, psychiatrists must be able to spot the nuance in symptoms, ask the right questions, and understand what the problem is.

 

Read More: http://snip.ly/u70ov#http://www.bbc.com/news/health-41201396

Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA)

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 Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA) . 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

 

The ISO 13485:2003 Standard has quality management systems at its heart

The ISO 13485:2003 Standard has quality management systems at its heart.

The ISO 13485:2003 Standard relates to quality management systems in the field of Medical Devices. Its requirements ISO 13485:2003 specifically relate to organizations that are in the business of medical devices, no matter what its size or type. At its core, ISO 13485:2003 is all about quality management systems in medical devices.

This standard specifies requirements for a quality management system. Accordingly, it requires an organization to demonstrate the ability to produce medical devices and related services that have to consistently meet both –a) customer requirements and b) regulatory requirements –that are applicable to the file of medical devices and related services.

Harmonization at the core

It thus becomes clear that quality management systems, which are the means to ensuring these requirements, constitute the heart of ISO 13485:2003. This Standard’s essential objective is to foster and bring about harmonization among medical device regulatory requirements for meeting quality management systems. This Standard superseded the earlier version, the ISO 9001. It did away with some of the requirements of that Standard.

When a medical device company deals with medical devices it may not manufacture; it is its responsibility to ensure that processes applicable to the medical device(s) required by ISO 13485:2003, are accounted for in the organization’s quality management system.

In a nutshell, these are some of the requirements set out from Part 4 of ISO 13485:2003 onwards, the Part at which quality requirements begin:

4.1: Establish a quality system for medical devices;

4.2: Document your medical device quality system;

5.1: Support Quality;

5.2: Focus on customers;

5.3: Establish a Quality Policy;

5.4: Perform Quality Planning;

5.5: Control your Quality Management System;

5.6: Carry out management reviews;

6.1: Provide quality resources;

6.2: Provide Quality personnel;

6.3: Provide quality infrastructure;

6.4: Provide quality environment

8.2: Monitor and measure quality;

8.3: Control your nonconforming products;

8.5: Take required remedial actions


References:
http://www.iso.org/iso/catalogue_detail?csnumber=36786
http://www.praxiom.com/iso-13485.htm

Thanks & Best Regards,
John Robinson
GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
Web: www.globalcompliancepanel.com
Email: john.robinson@globalcompliancepanel.com

Excel spreadsheet validation to eliminate 483s

One of the basic issues for organizations in the regulated area is to carry out Excel spreadsheet validation to eliminate 483s.

Why is this so? The FDA requires validation of electronic records, and this is a key requirement. The FDA has its set of regulatory requirements set out in 21 CFR Part 11. This code requires pharmaceutical, biotech, medical device, CRO, life sciences or related FDA-regulated organizations electronic records to be compliant with it. From this, the importance of Excel spreadsheet validation to eliminate 483s can be understood, because configuring an organization’s Excel spreadsheet application is a key requirement.

Making electronic records as genuine as physical records

21 CFR Part 11 is a set of FDA requirements, with which organizations have to comply to demonstrate that the electronic records they use are as good as the same as paper records in terms of genuineness. This is a core requirement for ensuring that electronic records do not get manipulated.

It is to nullify the drawbacks of using electronic records that 21 CFR Part 11 has to be implemented. One of the important aspects of 21 CFR Part 11 is Excel spreadsheet validation. Organizations need to know how to do Excel spreadsheet validation to eliminate 483s. The important benefit of being compliant is that it not only helps organizations avoid 483’s; when done properly, it saves two-thirds of the validation time and costs.

What does it take?

If an organization has to use Excel spreadsheet validation to eliminate 483’s, it needs to:

  • Know what does and does not need to be validated.
  • Know how to configure spreadsheet applications for Part 11 compliance
  • Have an understanding of how to use Excel’s built in 21 CFR Part 11 features for audit trails, security, data verification, and multiple concurrent users
  • Use risk assessment to reduce testing and improve productivity.
  • Specify and test its own GxP Excel application
  • Create a User Requirements document for the application
  • Create a Project Plan document for the application
  • Create a Functional Specifications document for its application
  • Create a Hazard Analysis document for its application
  • Create a Testing Protocol document for your application

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