3D Printing: FDA Finalizes Guidance for Medical Devices

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The US Food and Drug Administration (FDA) on Monday finalized guidance on medical device additive manufacturing, also known as 3D printing.

The guidance finalizes the draft version from May 2016 and largely keeps intact the recommendations and considerations laid out in the draft.

FDA Commissioner Scott Gottlieb said Monday that the guidance “will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and [ensures] our regulatory approach is properly tailored to the unique opportunities and challenges posed by this new technology.”

Gottlieb also said that FDA has now reviewed more than 100 3D printed medical device applications, including knee replacements and implants used for facial reconstruction, up from the 85 reviewed at the time the draft was released.

FDA describes the guidance as a “leap-frog” guidance in that it is meant to provide manufacturers about its initial thinking on manufacturing 3D-printed devices and how to characterize and validate such devices. The final guidance also emphasizes that the recommendations made will not be applicable to all 3D-printed devices due to the wide array of available additive manufacturing technologies and materials.

Some changes in the final guidance include new considerations for handling complex design files and cybersecurity considerations for patient-matched devices.

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Crypto-Mania Grips Hong Kong as City Looks for Life Beyond Banks

In the mid-1990s, Johnson Leung embarked on a career in shipping. In the early 2000s, he moved to finance. And now, he runs a Hong Kong startup that aims to improve how container ships are booked using blockchain technology.

Many in Hong Kong hope the city can make a similar leap. The shipping and banking hub, which has struggled for years to nurture a domestic technology industry, is embracing the blockchain revolution as it looks for new sources of growth.

Skeptics say it’s a risky bet on an unproven technology — one with more than its fair share of hype and, in some cases, fraud. But a growing number of Hong Kong entrepreneurs and policy makers are convinced the online ledger system that underlies cryptocurrencies like bitcoin will eventually reshape everything from financial services to supply chains. They say the city’s laissez faire approach toward regulation, along with its expertise in finance and logistics, make it a natural hub for blockchain startups.

“I don’t see why Hong Kong can’t be a leader of blockchain technology,” said Leung, who co-founded 300cubits.tech after more than a decade in the financial industry that included stints as a research analyst at JPMorgan Chase & Co. and Jefferies Group LLC. “It’s so new that it’s not like any country has a huge advantage compared to us.”

Hong Kong’s government has been throwing resources at the technology. The city’s monetary authority is developing its own digital currency and is testing blockchains for trade finance, mortgage applications and e-check tracking. Hong Kong’s securities regulator has joined R3, a global consortium that develops blockchain technology for financial transactions, while a government-backed research institute has worked on a blockchain-based system for tracking property valuations, among other initiatives. Hong Kong Exchanges & Clearing Ltd., the city’s publicly-traded exchange monopoly, plans to start a blockchain platform for early-stage companies and their investors next year.

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A common technique plots the data to help detect trends, cycles, and shifts

Some of the functions of medical device manufacturers include:

o  Analyzing complaints

o  Processing data

o  Evaluating nonconformances

o  Utilizing other quality data sources.

The main purpose of this analysis, done using appropriate statistical methodology, under §820.100, is to identify the cause of nonconforming products and other quality problems. Time series analysis is one such family of these tools. Also called trending analysis, time series analysis uses visual methods to plot data over time.

A common technique plots the data to help detect trends, cycles, and shifts. The major use of these valuable methods is that they can help anticipate problems before they occur and demonstrate the effectiveness of corrective actions.

A webinar from Compliance4All on time series analysis

Dan O’Leary, President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management, will be the speaker at a webinar that analyzes time series analysis. This webinar is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Please visit methods when the data has a time based order to register for this webinar on time series analysis.

Full explanation of time series analysis

At this session, Dan will explain the graphical methods. In addition, he will also demonstrate some analysis techniques using Excel. Some special cases including data smoothing using moving averages, analysis with a lag function, and statistical process control (SPC), will be explained. By attending this webinar, participants will be able to gain understanding of time series analysis and some Excel capabilities to help perform the analysis. These tools are valuable for improvement projects and reporting information to management.

When the appropriate method is not clear, data analysis can be difficult. At this webinar, Dan will explain the methods when the data has a time based order. Excel includes functions and methods that can one can use to analyze the data and present it in a meaningful way.

Meaningful objectives

In this webinar, which will be of immense use to professionals who use statistics in their quality requirements, such as Quality Engineers, Manufacturing Engineers, Design Engineers, Data Analysts, Auditors, CA&PA Specialists, and Quality Managers; Dan will impart the following objectives:

o  Using run (trend) Charts

o  Determining a Linear Trend

o  Data Smoothing (Moving Averages and Lag Functions)

o  Using variables Control Charts(x-bar & R).

Which leads to fines in the millions of dollars per intrusion

Developments in the area of medical device software –i.e., the software that is put to use in medical devices –have been taking place at such a torrid pace that regulatory agencies such as the FDA have been unable to keep pace with them. Almost invariably, every development in medical device software brings about a new level of complexity.

Also, the classification of the device is another factor the FDA and other regulatory agencies have had to contend with: Different regulations have to be made depending on whether the software in medical devices is to be classified as a device itself, is used to alter the performance of the device, or is used for computing values. The inability of the regulatory agencies to catch up with the speed of developments in the medical device software arena has had the agency scurrying for quick solutions.

Among these are its decision to integrate the current provisions of voluntary standards developed by the National Institute of Standards and Technology (NIST), which it considers as a useful guidance for medical software professionals and voluntary information sharing organizations to meet cybersecurity challenges into its regulatory oversight. The onus of being knowledgeable about FDA regulations thus rests on firms that design and market software.

Learning on all the aspects of medical device cybersecurity

A formal learning session that examines this complex relationship is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. The speaker at this webinar is Casper Uldriks, ex-FDA Expert and former Associate, Center Director of CDRH. Participants who wish to gain clarity on these aspects of medical device cybersecurity can register for this webinar by visiting National Institute of Standards and Technology

The speaker at this webinar will seek to help participants identify the FDA’s fundamental premarket and postmarket requirements that involve software. When medical device companies go to the FDA for approval to market their product; they need to be very well informed about everything that the FDA states and requires in this regard, because, as we have examined, the burden of design factors requires well informed considerations about how medical device manufacturers protect their product’s software and how they outsmart increasingly sophisticated cyber attackers.

All-round plans

At the same time, device manufacturers also need to be totally compliant with the regulatory options and responsibilities lie with them when a cybersecurity problem is located in their device. Their responsibilities include plans about how to recover and publicly disclose cyberattacks, especially when private medical records are involved. Not getting this right leads to fines that run into millions of dollars for every breach.

So, their cybersecurity efforts should be inclusive of important factors such as these among others:

o  Design planning

o  Postmarket vigilance

o  Training for employees

o  An action plan for managing an attack.

Learning on the factors to consider

Casper will help participants identify these basic considerations at this webinar. He will explain the kind of device cybersecurity programs that protect and foster the performance of device based software or standalone software that device manufacturers need to instill in order to assure the safe use of the device. Such programs need to use the FDA’s premarket and postmarket information requirements when entering and staying in the market.

This session is of very high value to professionals who deal with some or another form of medical device software and its marketing. This includes those in Regulatory Affairs, Quality Assurance, Software Design Engineers, Manufacturing, the Complaint Department, Hospital Risk Department, and those who market their own labels.

Casper will cover the following areas at this webinar:

o  FDA’s Cybersecurity Premarket Design Information

o  FDA’s Postmarket Controls

o  Voluntary Controls

o  Cybersecurity Training

o  Recovery Plans.

Techniques to Follow Which Increase the Confidence in the Audit

Auditing is a very important aspect of quality in all the areas of the medical sciences. An audit is the most reliable and foolproof method for evaluating the extent to which the various activities in an organization comply with the requirements and expectations the principal has from those to whom various processes are outsourced. Audits are the main tools for a quality unit to monitor and ensure that those activities are performed in compliance with the manufacturer commitments for quality and regulations.

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An audit is also essential to ensure that the organization meets guidelines set out by the regulatory authorities. Its uses are more pronounced in areas such as medical devices, clinical research, pharmaceuticals, and other areas of the life sciences which require adherence to very accurate and rigorous standards of processes, procedures, quality and policies.

Further, audits are also conducted to assess the quality of material supplied by vendors, who could be from fields as varied as accounting to software to claims settlements to medical products. In this era of outsourcing, it is but natural to expect players in the healthcare industry to outsource several of their activities for a number of reasons.

An audit is extremely crucial in all these activities in the life sciences industry, because it helps to control quality and save costs and many troubles that could come up if the processes are not adhered to. Outsourcing only saves the manufacturer or the provider the trouble of having to do many activities by himself; it does not absolve him of the legal responsibility. The law is very clear on this: Whenever there is noncompliance with the regulatory guidelines; it is the principal, or the provider, on whose shoulders the blame squarely lies.

An audit is effective, but only if done rightly

It is for this critical reason for which audits have to be performed, both internally and externally. But then, an audit can fail too, if it is not done properly. In the field of medical sciences, there are well-established good practices and best practices in many areas, such as Good Manufacturing Practices, Good Laboratory Practices, and so on, but there is no such convention as a Good Auditing Practice. This makes the voluntary inculcation of best practices an imperative for professionals in the areas of medical auditing.

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This is of extreme importance considering that most areas of the medical sciences deal with human lives. A high value is attached to audit practices, as an error from any of them, such as Contract Manufacturing Organizations (CMO’s), subcontractors, and suppliers of many items can have very bad consequences.

 

A learning session on auditing of CMO’s

The concept of Good Auditing Practices may not have evolved yet, but guidelines, techniques, and practices are in place to ensure that the audit meets its requirements and fulfils its objectives relating to quality.

Want to explore the matters that go into making medical audits successful and how to audit CMO’s to ensure that the products and processes required in a number of areas of the life sciences comply with the regulatory guidelines? Then, a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will help you do this.

This webinar will have Eyal Learner, who is owner of ELC Consulting Services, which offers the pharmaceutical and medical devices industries support in all quality related issues, as the speaker. To gain insights into how to carry out audits and ensure an effective means of evaluating compliance with the objectives of the Quality System,  especially when it concerns suppliers and outsourcing operations like CMO’s, service providers, sub-contractors and raw materials suppliers; please register for this webinar by logging on to 3rd Party and Subcontractors

Helping auditing serve its purpose

At this webinar, Eyal will explain the vital purposes of auditing and the ways of ensuring compliance with the quality and regulatory standards set out by the regulatory agencies using the right auditing techniques. He will show practical aspects of auditing. Although auditing is based on set principles and is a well-planned activity; auditors have to contend with changes that keep coming up abruptly, unannounced.

Auditors need to be prepared for handling such situations, which is what Eyal will help understand. He will explain the audit techniques and skills needed in situations like this and show ways by which to make the audit to be successful and efficient. This course is particularly aimed at auditors, potential auditors and auditees working for the pharmaceuticals, medical devices, and API and Excipients industries.

Eyal will cover the following areas at this webinar:

  • Short regulatory overview on external audits
    • GMP Requirements
    • Types of Audits
    • Rights & Duties
  • Planning
  • Off-site Assessment
  • Prefaces to Audit Techniques
  • General Techniques
  • Specific Techniques
  • FDA’s Quality System Inspection Technique (QSIT)

CAPA and Follow-up.

Tool for Checking Corporate Revenue Accounts Frauds

Corporate revenue account fraud and account manipulation are serious issues for businesses in many parts of the world today. Although legislations such as Sarbanes Oxley have been passed with the intention of making corporates more accountable; corporate accounting is still vulnerable to manipulation and fraud. A company’s financial statement is a primary area in which a fraud can happen.

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A financial statement is the elementary piece of documentation which reflects a company’s financial stature. It mirrors the company’s financial health, and is the document that is taken up as reference for discussion and clarification during shareholders’ and board members’ meetings. Since they contain information about cash flows, balance sheets and income statements; financial statements are the reference point for judging the financial situation of a company.

Why does fraud take place in financial statements?

Financial statement fraud can happen for a number of reasons:

  • It can be carried out to deflate figures, so that shareholders may be paid lesser dividends than they deserve
  • Financial statement fraud can also be to report lesser incomes, so that the company pays lesser tax
  • They can also be inflated to raise more funding and capital

Financial ratios as a means of detecting financial statement fraud

Among the many mechanisms used for detecting financial statement frauds; financial ratios are an important one. They can be used to analyze and interpret the numbers in financial statements to arrive at an understanding of important aspects such as the following among others:

  • Is the company holding excess inventory unnecessarily?
  • Is it running a heavier debt than is necessary or manageable?
  • Are the payments from customers coming rightly, fully and on time?
  • Is the company spending a lot more on production than is necessary, i.e. is its operating expense on the higher side?
  • How is the company utilizing its resources and assets to generate revenues?

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Ways of using financial ratios to detect frauds

A financial analyst, or anyone connected with the company’s financial statements, such as a chartered accountant, auditor, stakeholders, and board members and so on, can use financial ratios to quickly analyze the situation. Whenever there is a change in the allocation or revenues from each source, the extent to which the changes happened needs to be explained. Unless there is a reasonable or convincing reason for which the values change from one year to another; it becomes a potential red flag that is worth investigating into.

And the percentage or extent to which the ratio changes in relation to the industry average can also be used as a reference. If the industry average for a certain item is say, 15% of the expense, and if there is a perceptible change in it from one year to another in a company’s financial statement, then that is something that needs to be looked into.

These are just a couple of examples of how ratios can potentially show up mismatches and anomalies in the financial statement.

Full learning on how to use ratios for detecting fraud

Is there a way of detecting these account frauds before they happen? Which are the warning signs and red flags that need to be taken note of when checking financial statements, so that these frauds are detected early, and the damage limited?

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will show which these are, and how they can be used. This webinar will offer an in-depth, professional way of using ratios for detecting financial fraud in companies.

At this webinar, Mike Morley, who is a Certified Public Accountant, business author and an entertaining and informative speaker and a recognized authority in the field of finance, will be the speaker. Mike offers various training programs, such as IFRS, SOX, and Financial Statement Analysis that focus on providing continuing education opportunities for finance and accounting professionals. It is this wide-ranging experience that Mike brings into this session on using ratios for fraud detection.

Please register for this webinar by visiting Detection in Corporate Revenue Accounts Michael will offer an overview of some of the best practices in ratio analysis for fraud detection in corporate revenue accounts used today. This will be highly useful to participants from the Finance sector, such as Accountants, CFO’s, Auditors –External and Internal, Business Managers, Forensic Accounting Researchers, and Fraud Investigators.

Mike will cover the following areas at this webinar:

  • External Pressures that Might Lead to Committing Financial Reporting Fraud
  • Internal Red Flags that Might Affect the Revenue Accounts
  • Ratios that Help Spot Unusual Financial Results
  • Ratios that Indicate which Transactions should be Analyzed in Detail
  • Ratios for Finding Account Balances that Might be Inflated

Ratios for Verifying the Relationship Between revenue and other Accounts.

How to Comply and how to Protect Privacy

The General Data Protection Regulation (GDPR) –codified as Regulation (EU) 2016/679 – is an important law concerning the protection of data of all people living in the European Union (EU). Through the GDPR regulation; all the legislative and secretarial bodies of the EU, namely the European Parliament, the Council of the European Union and the European Commission, fortify and toughen and unify all aspects of data protection for all individuals within the European Union (EU).

Business, Technology, Internet and network concept. Young businessman showing a word in a virtual tablet of the future: Data protection

Another area that is addressed by the GDPR is the export of personal data to regions outside the EU. The core purposes for which the GDPR is enacted are twofold:

  • Giving control back to citizens and residents over their personal data
  • Simplifying the regulatory environment and bringing about uniformity and unity in data protection regulations across the EU to facilitate the ease of doing global business within the EU.

The GDPR will be the new law without requiring members to endorse it

The GDPR came into effect when the European Commission adapted the proposal for its creation on January 25, 2012. When the GDPR comes into effect and becomes enforceable from 25 May 2018 after a two-year transition period after being adopted on 27 April 2016; it will replace the data protection directive that has been in use in the EU from 1995: Directive 95/46/EC.

The all-powerful nature of this regulation can be gauged from the fact that it does not require legislative support from any of the EU members. It straightaway becomes law and will be directly binding and applicable from the date of its enforcement.

Benefits of the new legislation

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The GDPR will come with many advantages:

  • It will offer greater and clearer insight into Personally Identifiable Information (PII) processing within the company
  • It will boost security controls and unify these across the 27 EU members
  • It brings about increased customer confidence, since there are stronger safeguards for data protection
  • It will relax the process of doing business in the EU

Drawbacks of the GDPR for companies that want to do business in the EU

While the primary objective of the GDPR is smoothing the laws for allowing global businesses in the bloc; it comes at a rather expensive price tag: If companies fail to comply with the GDPR provisions on data protection, they end up coughing up two percent of their worldwide revenues in penalties!

These are some of the other pain areas of the GDPR:

  • Provisions stipulate fines of up to € 20 million
  • Inviting a host of complicated lawsuits
  • Loss of reputation
  • A host of liability cases

These facts about the GDPR make it necessary for companies in any line of business that want to gain access to the huge EU market to get a complete and clear grasp of the nuances of this new legislation. This is absolutely necessary if they have to avoid the consequences of noncompliance.

Get to understand the ways of the GDPR

This is the learning that a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering. Derk Yntema, who has over 15 years of experience in ICT and security-management and has demonstrated capacity to implement innovative security programs that drive awareness towards information security and strengthen organizations and proven knowledge of privacy legislation and helping companies towards privacy compliance, will be the speaker at this session.

To get a full and proper understanding of the GDPR and how it affects your business, please register for this webinar by visiting Security Controls up to level

At this webinar, which will be of very high value to professionals such as Board of Directors, Supervisory Board, CxO’s and Compliance Managers/Officers; Derk will cover the following areas:

  • What is Privacy?
  • How to Protect Privacy
  • What is PII?
  • What is in the GDPR (General Data Protection Regulation)
  • How to Comply.