Why Trade Compliance and Logistics Must Work Together

Why Trade Compliance and Logistics Must Work Together1

Trade compliance and logistics must work together for a number of important reasons. While on the surface, trade compliance for logistics may seem burdensome for many organizations, the benefits of getting their trade compliance and logistics to work together are multifold and far outweigh the short term effort that goes into it, and that of noncompliance.

Undoubtedly, the most important reason for which trade compliance and logistics must work together is that they ensure that there is compliance with the laws of the countries into which the goods travel. It is a lot easier and a lot uncomplicated to have goods moving within national boundaries, where one can expect familiarity with the rules and the operating environment. In the case of global trade, the story is different.

Need to grapple with multiple laws

why-trade-compliance-and-logistics-must-work-togetherThere is great diversity and complexity of laws that govern trade compliance and logistics. They are now more integrated than at any point of time before because of the advent of new technologies. This brings in a motley mix of the elements of global business, such as currencies, laws, locations, people and so on. Businesses that have a stake in the global trade have to deal with these varieties and diffuse elements. One of the surest ways of ensuring that these are managed rightly is by getting trade compliance and logistics to work together.

Since there is a multitude of international laws that need to be complied with at many stages of the global supply chain; trade compliance and logistics must work together. This is the only sure way of ensuring that the company’s goods and products meet the required international trade guidelines and reach their destination safely.

A way out of the complexity

why-trade-compliance-and-logistics-must-work-togetherFor many in the business of exports, complying with the global supply chain may seem complex. However, knowledge of the laws of respective countries and building a sound logistics and supply chain infrastructure will go a long way in mitigating the problems associated with these. This is why trade compliance and logistics must work together.

Imagine a consignment of textiles originating somewhere in the Middle East headed for North America. This consignment has to pass through a few countries, at each of which it has to be sure it meets the compliance requirements. Finally, even when it reaches its destination, it must ensure that the laws of that country are complied with.

Increased efficiency and enhanced reputation 

why-trade-compliance-and-logistics-must-work-togetherAnother important reason for which trade compliance and logistics must work together is that there are substantial long term gains to be had by doing so. Supply chains that have come about as a result of trade compliance and logistics working together become more reliable and efficient. All these mean reduced costs in the long run, increased customer satisfaction, and enhanced reputation in the business.

Elaborating on the point above, it is also equally true that trade compliance and logistics must work together to pump up nations’ economic growth. A country that ensures that trade and logistics are in accordance with internationally legislated laws on the subject are more likely to be trusted by global businesses. Countries in which trade compliance and logistics work together and result in sound business infrastructure are naturally more preferred by businesses as transit routes or destinations for their products. This brings in substantial revenues to the countries.

 

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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.

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Effective Complaint Handling Guidelines serve as a basis for improvements in medical devices

Effective Complaint Handling Guidelines serve as a basis for improvements in medical devices1Far from being frowned upon, complaints should serve as an opportunity for medical device manufacturers to understand the customer’s expectations better and lead to improvements in the product quality.

The FDA describes a complaint as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution”.

FDA’s complaint handling guidelines are critical for ensuring that an organization maintains safety with regard to the medical devices they manufacture. Errors in medical devices can result in complaints, and improper handling of complaints can lead to problems for the patient, ranging from injury to fatality.

It is to prevent these problems that the FDA has issued complaint handling guidelines. FDA’s thinking is based on the reasoning that a complaint may be an indicator of serious safety, but implementing effective complaint handling guidelines can greatly mollify the gravity of the issue. It is also the first step to initiating new product development, which in turn has the potential to greatly reduce risks associated with noncompliance.

Regulations in place

Provisions relating to effective complaint handling provisions are contained in FDA 21 CFR Part 820 and GxP regulations.

Firstly, these complaint handling guidelines require medical device manufacturers to maintain complaint files. Manufacturers have to make this the first step towards establishing a sustainable complaint management system.

Secondly, Section 198 of Part 820 warrants the following:

effectiveComplaintHandlingGuidelinesThirdly, FDA 21 CFR Part 820 requires the manufacturer to establish and maintain procedures for the receipt, review, and evaluation of complaints.

What should records of investigation contain?

Records of investigation should contain the following:

  • Identifiers related to the device and reported event
  • If Medical Device Reporting is made, it should investigate the following:
    • Whether there were any specifications the device failed to meet
    • Whether it was for treatment or for diagnosis that the device was being used
    • In what way the device was related to the reported event, if applicable

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Business Process Management in Healthcare helps reduce inefficiencies

What are the components of a Financial Audit Program1

For many years before the advent of automation and computerization ,healthcare processes, such as billing, admissions, and many elements of care were carried out manually. Although it was a capable method to quite an extent, it relied on the use of the manual process or the human method. This was always prone to mistakes and errors, because humans are prone to committing errors that can creep in even with the best of intentions, as a result of which the healthcare industry ended up losing billions of dollars that could otherwise have gone into meaningful forms of investment.

A result of technological developments

This is why Business Process Management (BPM) in Healthcare came into existence with the advent of and as a byproduct of automation. Business process management in healthcare is being considered a major step in helping healthcare settings reduce costs and inefficiencies. When a unit implements business process management in healthcare; there is an automatic reduction in errors and inefficiencies. Let us see how:

Impetus from the higher authorities

insurance in crystal ball, Life insurance concept

There is now a general tendency and effort to push for automation in the healthcare industry. Even the American Congress has been aggressively pushing for reforms in the healthcare industry, a prime feature of which is fostering business process management in healthcare. Overall, BPM in healthcare is a means for improving efficiencies throughout the healthcare chain and bringing about greater integration and accountability through automation.

Core areas of business process management in healthcare

Business process management in healthcare is useful across the healthcare process chain, but is particularly so in at least there important areas:

Billing:This is one of the prime areas in which business process management in healthcare can make a huge difference. With complete automation of this critical area of business, healthcare units ensure that there is total coordination and traceability of the billing process.

Software:Apart from billing, another area in which business process management in healthcare helps tremendously is software. Software applications can bring about a huge change in the speed of operations. This area of BPM in healthcare reduces the need for human intervention at various stages of the business process.

Big data:Another of the areas in which business process management in healthcare holds huge promise is big data. Big data can help to make sense of various data used in healthcare administration and disease management across entire geographies. This makes the role of business process management in healthcare all the more meaningful and exciting.

 

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Digital Marketing for Pharmaceutical companies offers tremendous opportunities

There is enormous potential for digital marketing for pharmaceutical companies. Proper exploitation of the social media can take pharmaceutical companies to their market in a more pinpointed and accurate manner than traditional marketing.

Gone are the initial days of reluctance on the part of pharmaceutical companies to embrace social media as a powerful marketing medium. That was in the past, when the concept of social media was new, and regulations in the pharmaceutical industry had yet to catch up with explosive pace at which the social media grew.

More and more pharmaceutical companies are on the social media

Today, one is likely to see any pharmaceutical company worth its name being active on YouTube, Facebook and Twitter to interact with its customers. Changes brought about by digital marketing in the pharmaceutical industry have seen companies like Johnson and Johnson and Pfizer being among the several majors associated with YouTube lately for creating and promoting their image. This is a result of the realization that social media can, far from being unconducive to the industry, can be quite amiable to it.

  • In a study in late 2014, the New England Journal of Medicine estimated that leading pharmaceutical companies spend up to a quarter of their marketing budgets on the social media
  • The study pointed out that the social media were as powerful and effective as EHRs and mobile applications as marketing tools, signaling a new dynamic for digital marketing in the pharmaceutical industry.

Social media as a key differentiator

The defining area in which the social media can be different and more effective than traditional marketing tactics for pharmaceutical companies is this: earlier methods such as trade conferences, promotions, gifting doctors for prescribing a company’s brands were effective, but were carried out outside the healthcare setting and in isolation of the patient. The reach and intervention of the social media has made digital marketing for pharmaceutical companies so much more effective that they can get right into the arena of treatment and be of assistance with valuable inputs and suggestions.

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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.

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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.

 

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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