Global Supply Chain Regulatory Compliance

Global supply chain regulatory compliance has become more important than ever before because of the confluence of a number of factors. As globalization becomes inevitable and inescapable, the global supply chain is one of the core arenas in which it plays out. The outgrowth brought about by globalization, namely outsourcing, has further increased the need for global supply chain regulatory compliance.

Global supply chain regulatory compliance has now become something on which organizations cannot compromise. Any shipment of any item that reaches foreign shores can get rejected if it has not met global supply chain regulatory compliance. Such a consignment could even get labeled as counterfeit. This explains the importance and need for global supply chain regulatory compliance. Being in global supply chain regulatory compliance means adhering to even the local laws of the foreign country into which goods and products are exported.

Governments have become more stringent 

global-supply-chain-regulatory-complianceAs a result of these trade and technological developments; governments all around the world without exception are jumping on the bandwagon to formulate laws that apply to the supply chain industry. For most governments, global supply chain regulatory compliance is a must. They are becoming extremely strict in enforcing these laws and are handing out severe punishments to businesses and organizations that are lax in enforcing global supply chain regulatory compliance. Most countries are legislating laws regarding global supply chains almost exclusively, in a way that other political acts are framed. This has pushed the need for global supply chain regulatory compliance further.

Other related developmentsAs technologies advance in the global supply chain, many developments in auxiliary and supplementary fields have hastened global the push for supply chain regulatory compliance requirements. For example, heavy paperwork, which used to be hallmark of most merchandising businesses, has made way for automation. Global supply chain regulatory compliance has to take factors such as these into consideration.

global-supply-chain-regulatory-complianceOther developments in allied areas such as intellectual property rights have gone on to strengthen the role of global supply chain regulatory compliance. As countries demand greater protection for their intellectual property products, they use global supply chain regulatory compliance as an instrument to enforce these, when these products concern exports.

In addition, there could also be other critically important issues in global supply chain regulatory compliance that may not be related to any of these, but can play a decisive role in disrupting global businesses. Think of natural disasters such as the Fukushima earthquake or the many natural disruptions such as hurricanes in South and North America. These could throw businesses out of gear. Global supply chain regulatory compliance is a kind of insulation against the uncertainties caused by events such as these.

In other words, global supply chain regulatory compliance should leave no stone unturned. There is no scope for compromise of any kind in implementing global supply chain regulatory compliance provisions.

Items that go into global supply chain regulatory complianceMeeting global supply chain regulatory compliance requirements means having to take care of a number of ingredients. Some of these are:

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Upcoming crucial global supply chain regulatory compliance regulation in the USSeveral legislations aimed at bringing about global supply chain regulatory compliance are in place. However, at this point of time, a really crucial global supply chain compliance regulation that could play a major role in the US in the coming years is the Automated Commercial Environment (ACE).

global-supply-chain-regulatory-complianceIn a nutshell, this U.S. Customs and Border Protection (CBP)-mandated regulation aims to bring in place a single portal which will make information on imported goods flow electronically from the businesses themselves right to the respective departments or agencies that require and handle them. The ACE is aimed at making import and export related work paperless, while also seeking to become a major facilitator of trade.

 

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Understanding the infinite area of medical device compliance

Understanding the infinite area of medical device compliance 1.pngWith a seemingly unlimited number of products coming under the broad umbrella of medical devices; it is but natural that regulations for these products are equally expansive. This makes medical devices compliance an extremely enormous and broad topic.

With the FDA being the sole regulator for this very vast area; it comes up with regulations, and expects medical device manufacturers to comply with them. This is part of the FDA’s primary function of assuring quality from medical devices. Compliance with these medical device regulations ensures that companies’ products meet the quality and safety and integrity of medical devices.

Areas of medical device compliance regulations

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The FDA’s regulation of medical devices and a few nonmedical devices cover the areas of manufacturing, repackaging, and relabeling, and/or importing. The regulations for medical devices are set out in 21 CFR Part 807, whose various sections detail all the requirements for compliance for Class I, II and III medical devices. The following are the activities connected with compliance for medical devices:

  • Registration of the establishment
  • Listing of the medical device
  • 510 (k)
  • Premarket approval
  • Investigational Device Exemption (IDE)
  • Quality Systems
  • GMP
  • Device labeling
  • Device reporting.

A thorough understanding of the FDA medical device compliance areas

Understanding the infinite area of medical device complianceThe ambit of the FDA’s regulations being very wide; it is important for medical device companies to have clarity on the many FDA medical device compliance regulations. This understanding will be offered at a seminar being organized by GlobalCompliancePanel, a very well-known provider of professional trainings for the areas of regulatory compliance.

The Director of this two-day seminar is Susanne Manz, Quality and Compliance Expert/Auditor for Medical Devices, Manz Consulting, Inc.

Please register for this webinar by visiting Understanding the infinite area of medical device compliance . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Helping to strategize compliance for medical devices

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Medical device companies need to put in place a sound strategy for medical device compliance. A certain level of strategic thinking alone ensures this. Susanne will show participants how to inculcate this thinking and instill it into the organization. She will show how to be cost-effective while improving the quality and compliance of medical devices. The ways of building a sound Quality System, which is at the root of medical device compliance; will be imparted.

An effective and efficient Quality System can only be implemented based on a thorough understanding of what the regulatory requirements mean, and adapting them into the Quality System. The ways of doing this will be the core of this seminar. Susanne will demonstrate the ways by which to plan, structure and implement a Quality System that addresses the specific business needs of the participants.

Addressing issues within a Quality System

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The methods for identifying, prioritizing and analyzing risks will be explained during the discussion on how to create a quality strategy and plans. Susanne will help participants explore the capabilities needed for every medical device to meet quality standards and implement compliant Quality Systems.

Also taken up for discussion are areas related to continuous improvement, Six Sigma, and Corrective and Preventive Action (CAPA), which are important components for addressing issues within a medical device company’s Quality System. Susanne will help with this very important aspect.

Over these two days, Susanne will also take up other crucial aspects of medical device compliance. These include:

  • Effectively communicating and escalating risk
  • Monitoring performance and progress
  • Kick starting the Quality System to avoid common problems such as MDRs, recalls, 483s, and Warning Letters.

Susanne will cover the following areas at this seminar on medical device compliance:

  • Quality System Expectations
  • Quality System Structure
  • Strategy and Planning
  • Risk management in your quality system
  • Case for Quality
  • Inspection preparedness and management
  • Monitoring and metrics
  • Creating a quality strategy and plans.

continue to improve the medical device compliance

 

Effective legal writing skills are essential for FDA submissions

professionals in the pharmaceutical and medical device companies clearly understand and effectively employ legal writing techniques to frame persuasive argument when negotiating with FDA

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A number of reasons make cultivation of the art of effective legal writing skills for FDA submissions important. Documents that are submitted to the FDA are deeply technical in nature, because of which they make heavy reading. Being the product of studiously and meticulously carried out research and finding, these submissions are very scientific and technical. Mastering the art of making legal writing effective and embellishing it is necessary for those who make FDA submissions because this can make these documents lucid and pleasant.

It is the habit of most law schools to prepare future attorneys by teaching them the art of summarizing and sharpening intricate and heavy textual and academic matter into crisp, concise and credible arguments. It is in situations such as drafting responses and applications to FDA that these kinds of writing skills become vital. The FDA expects responses to their queries, or for that matter, any poser that requires a response, to be very exact, scientific and technical. So, developing the art of effective legal writing skills for FDA submissions is a big need for those who prepare legal documentations.

Ridding submission documents of heavy text

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Making submissions about the product apart; effective legal writing skills for FDA submissions need to be developed for another important reason. Companies have to paddle through a muddle of legally heavy, often confusing regulations, which are legally binding requirements that are based upon statutory laws and judicial opinions.

Professionals in the pharmaceutical and medical device companies are required to handle these and respond to these at the appropriate times. A firm grasp of the requirements for doing this is needed for clearly understanding how to frame persuasive arguments and to negotiate with the FDA.

Effective legal writing skills can contribute to success in FDA submissions

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Effective legal writing skills for FDA submissions can stand between the success and failure of many new drugs, biologic or medical device projects, because a document that is confusing and is laden with incomprehensible jargon confuses the regulatory authorities and could become a reason for rejection of the submission.

This is why the more persuasive and articulate these arguments; the greater the chances for the company’s products of getting approvals from the FDA. All these facts make the cultivation of effective legal writing skills for FDA submissions extremely important.

Major learning on effective legal writing skills for FDA submissions

Effective legal writing skills are essential for FDA submissions

The ways of making legal writing skills effective for FDA submissions will be the topic of a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing.

The Director of this highly important and rewarding session on legal writing skills for FDA submissions is Robert Michalik, a Massachusetts regulatory attorney and founder of RegulatoryPro.com.  In order to get clarity on how to develop the right tools needed for effective legal writing skills for FDA submissions, please register for this webinar by just visiting Effective legal writing skills are essential for FDA submissions

Effective legal writing skills for FDA submissions improve the chances of success

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At this very valuable webinar on effective legal writing skills for FDA submissions, Robert will familiarize participants with the legal writing skills and practical techniques that will enhance their chances for success. Good regulatory writing may help to meet FDA branch-level requirements; but effective submissions that are laced with effective legal writing skills for FDA submissions can withstand scrutiny at the FDA Division level.

The seminar will be highly useful to any person working in Regulatory Affairs or Quality Management who is responsible for summarizing data and technical results, obtaining regulatory clearance or approval of a product, and selling or marketing regulated products. These include Regulatory Affairs professionals, Quality Assurance professionals, Marketing professionals, Scientific and Engineering/Product Development Managers, and Consultants to any regulated industry.

At this webinar, Michalik will cover the following areas:

Development of technical training in the life sciences

Developing Technical Training in the Life Sciences is a 2-day seminar that addresses the unique challenges of developing and managing training in Life Sciences companies. The Life Sciences pose unique challenges to training developers.

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Training and Development is a highly developed and evolved, broad body of knowledge. Many employees place themselves at a disadvantage vis-à-vis their colleagues in the absence of the right professional training and development. If employees have to consistently close gaps in their learning, they need to keep upgrading their knowledge and skills. They should also use training and development to understand how to meet the regulatory requirements the organization is required to comply with.

Difficulties of training and development in the life sciences

Development of technical training in the life sciences

This said; the need for technical training in the area of life sciences has not got the attention that many other areas have. Technical training and development skills in the field of life sciences is extremely important in helping professionals in that important area get proper guidance of the regulations in the areas of life sciences and benefit from them.

Technical training in the life sciences applications, however, has its challenges.  Mention needs to be made of two of them: A) The field of life sciences consists of activities such as formulating Standard Operating Procedures (SOPs), work instructions, and having to carry out tests and clinical trials, all of which are pretty complex. B) Regulations are often considered complex to grasp and implement.

A full understanding technical training for the life sciences

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GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a two-day seminar, at which professionals in the life sciences will become more familiar with training and development. It will also ease the complexity of their training needs.

The Director of this seminar is Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm that is celebrating its twentieth year of existence in 2017. Want to understand the importance of technical trainings for the life sciences and know how to implement legally compliant life sciences training programs for your organization? Then, please register for this seminar by visiting Development of technical training in the life sciences.  This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Kindling the interest in training for the life sciences

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Charles will essentially seek to ignite the training and learning needs of talented and technically competent training professionals who may need more focused instruction and direction in the area of technical training in the Life Sciences. He will examine the guidance that all training professionals need at all skill levels to truly build and sustain a training organization in today’s difficult corporate environment, and show how to effectively identify gaps in workforce training and compliance documentation and build effective and inexpensive training materials with the tools that are available.

A very important takeaway of this seminar is the learning of how to integrate Training & Development with compliance, so that the participants can leverage the benefits of compliance to improve the performance of the workforce and the overall performance of technical operations.

Personnel in the life sciences industries that are associated with training, such as Directors of Training, Training Supervisors, Training Coordinators, Training Developers, Instructional Designers and Instructors will benefit from this seminar. The following is the agenda of this seminar:

  • Introduction to Training and Development in the Life Sciences and the Relationship between Training and Regulatory Compliance
  • Training and Development Basics
  • The Building Blocks of Human Performance
  • Building a Training and Development Organization – Leverage what you have and Negotiate for What You Don’t
  • Perform a Documentation and Training Analysis – Discover the Gaps
  • Training Materials – SOPs and Work Instructions as Training Materials – It’s not as easy as you think! Leverage the Opportunity!
  • Working with Subject Matter Experts and Outside Consultants
  • Case Study Review and Discussion – This Approach Works!

Technical training in the life sciences

It is accepted that Training and Development is a highly developed area that bring its own body of knowledge. It uses a wide variety of techniques and approaches that are designed to meet the unique and complex challenges associated with training. Training and development is a great tool for helping a professional or a lay person alike understand the tenets of their profession.

In the absence of the right professional training and development, many employees place themselves at a disadvantage vis-à-vis their colleagues. They need to keep upgrading their knowledge and skills and keep closing the gaps, so that they do not get left out in their career. Training and development also helps employees understand how they need to meet the regulatory requirements the organization is required to comply with.

Difficulties associated with training and development in the life sciences

While this is accepted, a great deal of attention is yet to be paid to the need for technical training in the area of life sciences. Applying technical Training & Development skills to the field of life sciences is very crucial, as it helps professionals in that important area take a fresh perspective of the regulations in the areas of life sciences and benefit from them.

Technical training in the life sciences applications is fraught with a few problems. This is because two important factors come into play: The activities involved in the life sciences, such as formulating Standard Operating Procedures (SOPs), work instructions, the ways of carrying out tests and clinical trials, and the exact science behind the topics in this subject are all very complex. Secondly, regulations are equally difficult to understand and implement. This however, is no excuse to skip their implementation, something that is unthinkable for this industry.

A thorough learning session on technical training for the life sciences

It is to help professionals in the life sciences become more familiar with training and development, and to ease the complexity of their training needs that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a two-day seminar.

Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm that is celebrating its twentieth year of existence in 2017, will be the Director. To understand the importance of technical trainings for the life sciences and to get to know how to implement legally compliant life sciences training programs for your organization, please enroll for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900920SEMINAR?wordpress-SEO. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Arousing the interest in training for the life sciences

The purpose of this seminar is to help kick start the training and learning needs of talented and technically competent training professionals who may need more focused instruction and direction in the area of technical training in the Life Sciences. Charles will offer guidance to all training professionals at all skill levels in how to truly build and sustain a training organization in today’s difficult corporate environment, and how to effectively identify gaps in workforce training and compliance documentation and build effective and inexpensive training materials with the tools that are available.

A very important benefit participants of this seminar will take away from here is that they will learn how to integrate Training & Development with compliance, so that they can leverage the benefits of compliance to improve the performance of the workforce and the overall performance of technical operations.

Important personnel in the life sciences industries that are associated with training, such as Directors of Training, Training Supervisors, Training Coordinators, Training Developers, Instructional Designers and Instructors will derive high benefits from this seminar. Over the two days, Charles will cover the following:

o  Introduction to Training and Development in the Life Sciences and the Relationship between Training and Regulatory Compliance

o  Training and Development Basics

o  The Building Blocks of Human Performance

o  Building a Training and Development Organization – Leverage what you have and Negotiate for What You Don’t

o  Perform a Documentation and Training Analysis – Discover the Gaps

o  Training Materials – SOPs and Work Instructions as Training Materials – It’s not as easy as you think! Leverage the Opportunity!

o  Working with Subject Matter Experts and Outside Consultants

o  Case Study Review and Discussion – This Approach Works!

Unravelling the DHF, Technical File and Design Dossier

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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.

 

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Outstanding characteristics of the Design History File

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What should the Design History File contain?

The DHF should contain the following:

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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.

 

Learn more on this topic by visiting  :  http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900746SEMINAR?wordpress-SEO

 

 

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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