Facts – Until You Reach Your the New EU Medical Device Regulation

The Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject.

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The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

This will look at what to expect when the new regulation is implemented. Including: the transition period, Effect on Notified Bodies, Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.

-> Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States.

  • Clinical Trial Managers
  • Regulatory Affairs
  • Medical Officers
  • The updated Regulation
  • Implementation Dates and Transition
  • Main changes and Products Affected
  • Effect on Medical Device Manufacturers

New EU Medical Device Regulation

Effectively Dealing with Harassment and Its Relationship to Discrimination, Retaliation, and Hostile Work Environments

In any case of workplace harassment, an employer’s behavior must meet a certain standard in the eyes of the law. Just posting an anti-harassment policy, while a positive step, is insufficient to prove that an employer took workplace harassment seriously.

Workplace harassment isn’t limited to sexual harassment and doesn’t preclude harassment between two people of the same gender. The harasser can be a boss, a supervisor in another department, a co-worker, or even a non employee. The victim doesn’t necessarily have to be the person being harassed; it can be anyone affected by the harassing behavior.

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Harassment can also be considered a form of employment discrimination under various federal, state and local laws. In order to be considered discrimination, the harassment must be based on some protected trait. Under federal law, those traits include race, color, national origin, gender, pregnancy, age, religion, disability, and genetic information. Many state and local governments have enacted similar anti-discrimination laws.

Retaliation claims are costly and time-consuming for employers. Missteps in handling sensitive employee issues could result in the organization writing a check with a lot of zeros.

Additionally, workplace harassment may constitute a hostile work environment. Some conduct can be so severe on its own that even one incident can create a legal claim of workplace harassment.

How companies investigate potential misconduct can affect the company’s reputation as well as its bottom line.  Because cultural and generational diversity is changing the landscape of the U.S. workforce, that diversity can become fuel for all types of litigation. Understanding how to recognize harassment and effectively conduct workplace investigations can greatly reduce the chances of an organization being sued.

An employer can avoid or reduce liability by taking appropriate preventative measures. Participants will learn the best practices employers can employ to minimize the likelihood of retaliation violations.

Employers first need to understand exactly what harassment is: unwelcome conduct from a boss, coworker, group of coworkers, vendor, or customer whose actions, communication, or behavior mocks, demeans, puts down, disparages, or ridicules an employee. Physical assaults, threats, and intimidation are severe forms of harassment and bullying.  Harassment may also include offensive jokes, name-calling, offensive nicknames, pornographic images on a laptop, and offensive pictures or objects. Interfering with an employee’s ability to do his or her work also is considered a form of harassment.

Employees can also experience harassment when they are not the target of the harasser because of the negative work environment that can develop because of the harassment. This is referred to as a hostile work environment. Additionally, workplace harassment can result in claims of discrimination and retaliation.

Employers often overlook the importance of promptly investigating complaints of harassment and taking quick and appropriate corrective action. Since an employer’s prompt and effective response to complaints can limit or eliminate its liability in a discrimination, harassment, or retaliation lawsuit, it is imperative that employers implement an effective mechanism to investigate and resolve workplace complaints.

Charges of harassment in the workplace can result in costly consequences for companies. In 2017, the EEOC handled 84,254 charges and secured more than $125 million for victims of harassment and discrimination in private, federal, state, and local government workplaces.

http://bit.ly/2Fp65Dn

Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use

The complexity and vulnerability of software is expanding exponentially, so fast that Congress removed some device software from FDA’s jurisdiction. The remaining software regulated by FDA presents a degree of a risk to health that creates a public health concern. Part of that risk involves the intentional activity that can conflict, intrude or destroy software. The problems are taking center stage in the “healthcare software” dialogue. What issues can compromise or defeat the functional use of your software? Poor cybersecurity programs, lack of interoperability with third-party software, the wave of unmanageable apps and wireless home use technology. Original software design for an intended use is only the first step, the next design step is thinking about how someone can make your software worthless.

FDA’s changing regulatory controls

Cybersecurity management by design, oversight and preventive action

Ransomware attacks and recovery

Use voluntary standards and NIST

Mobile apps regulated and those not regulated

Wireless/home use software systems and human factors

Who will get the benifit with this

  • Business Planning Executives
  • Regulatory Directors
  • Software design and specification developers
  • Real time software performance auditors
  • Recall managers
  • In-house Legal Counsel
  • Customer support and service directors
  • Contract Specialists
  • Business acquisition Managers
  • Hospital Risk Managers

Know more at http://bit.ly/2CbGREq

Effective Technical Writing in the Life Sciences

Technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

After setting the stage for this content, we delve into the writing process beginning with the audience and how the audience must be analyzed to determine the level of writing that must be employed to complete the document.

Gathering the information to be included in the technical document requires collaboration between the writer and the various subject matter experts that possess the knowledge to be harvested. How that information is gathered can be an effective efficient process or an ineffective time-consuming endeavor all dependent upon the techniques employed to execute the activity. We will address the most effective techniques for extracting information from SMEs as well as those techniques that work best when observing procedures and activities to be documented.

Why you have to know

->Even with the advent of technology, we still communicate with the written word. Technical writing is about conveying information quickly, accurately, clearly, and succinctly. How we communicate, how we are understood, and how the message is received directly depends upon our skills as technical writers. In the life sciences, this skill is exceedingly important.

->In the life sciences, the stakes are high in terms of the writing’s ability to enable 100% accurate understanding of the content and where applicable, performance of the task or procedure documented. In the life sciences, that could mean the difference between life or death, safety or injury, loss or recovery, contamination or purity, success or failure.

->Unfortunately, technical writing is not a skill that is given much emphasis in college curriculums if any. Technical writing is a skill, life sciences workers are assumed to have and are expected to demonstrate at a level of skill usually beyond the capability of most. Unfortunately, most readers of technical writing are in the “same boat.” They “don’t know a good one when they see one.”  At the end of the day, in most cases, you have mediocre writing at best that may or may not convey the message intended.

->This virtual seminar will walk you through the technical writing process from start to finish. Each critical aspect of writing technical documents for the life sciences will be addressed with the goal of helping you become better technical writers. The tips and skills presented can be applied immediately and will be evident in the very first document that you write after this virtual seminar.

Writing technical material to include http://bit.ly/2SFohvo_Technical

The latest computer system industry standards for data [security]

Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.

The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.

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Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.

This seminar will help you understand the specific requirements associated with local and SaaS/cloud hosting solutions.

Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated.

Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.

Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.

Objectives of the Compliant with Part 11:

  • Understand what is expected in 21 CFR Part 11 and Annex 11 inspections
  • Avoid 483 and Warning Letters
  • Learn how to buy COTS software and qualify vendors.
  • Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
  • Requirements for local, SaaS, and cloud hosting
  • How to select resources and manage validation projects
  • “Right size” change control methods that allows quick and safe system evolution
  • Minimize the validation documentation to reduce costs without increasing regulatory or business risk
  • Write test cases that trace to elements of risk management
  • Protect intellectual property and keep electronic records safe

21 CFR Part 11/Annex 11 – Compliance for Electronic Records and Signatures:

  • What Part 11 means to you, not just what it says in the regulations
  • Avoid 483 and Warning Letters
  • Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
  • How SaaS/cloud computing changes qualification and validation
  • Ensure data integrity, security, and protect intellectual property
  • Understand the current computer system industry standards for security, data transfer, and audit trails
  • Electronic signatures, digital pens, and biometric signatures
  • SOPs required for the IT infrastructure
  • Product features to look for when purchasing COTS software
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents

Read more at http://bit.ly/2CVLELD_SaaS_Cloud

How the FDA interprets advertising and promotion in principle and in fact

If you go “off label” with advertising and promotion, FDA’s hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.

FDA’s Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. In contrast, FDA’s Center for Drug Evaluation and Research (CDER) uses long-standing regulations and a growing number of guidance documents in its regulatory approach. Policing social media has become a new regulatory responsibility and FDA is still trying to figure out how to deal with it. Bottom line, do you know when you fail to meet FDA’s requirements or are you guessing? Can you afford to guess? The cost to your business and the confusion left in your customers’ mind becomes an unwelcomed nightmare.

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In this seminar, you will learn how to navigate FDA’s numerous legal options and how to interpret them based on basic legal principles. Applying new guidance documents becomes a new test of the FDA’s legal boundaries and enforcement options. The agency is now conducting clinical studies and applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This academic discipline may or may not get to the root of what consumers take away as the message.

Congress and the new FDA Commissioner seem more sympathetic to expanding access to medical treatment before all the conclusive evidence for safety and effectiveness is evaluated by the FDA. Valid off-label information may take the lead in that direction.

This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. Operating in a stovepipe environment will not work. You need to understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm’s regulatory profile for advertising and promotion practices.

  • Sales and Marketing executives and managers
  • Regulatory Managers
  • In-house Legal Counsel and Contract Specialists
  • 3rd party consultants
  • Venture Capitalists
  • Investors
  • Business Acquisition Executives
  • Owners of New or Developing Firms
  • Own label distributors
  • International Trade Managers
  • Product specification developers

How easy it is to cross them

A to Z’s of HIPAA Privacy, Security, and Breach Notification Rules

It is designed to provide intensive, two-day training in HIPAA compliance, including what’s new in the regulations, what’s changed recently, and what needs to be addressed for compliance by covered entities and business associates.

It provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate.

Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided.

Benefits from this Rules:

  • Information Security Officers
  • Risk Managers
  • Compliance Officers
  • Privacy Officers
  • Health Information Managers
  • Information Technology Managers
  • Medical Office Managers
  • Chief Financial Officers
  • Systems Managers
  • Legal Counsel
  • Operations Directors

HIPAA Privacy Rule Principles, Policies and Procedures

  • Patient Rights under HIPAA
  • Limitations on Uses and Disclosures
  • Required Policies and Procedures
  • Training and Documentation Requirements

Recent and Proposed Changes to the HIPAA Rules

  • New Penalty Structure
  • New HIPAA Audit Program
  • New Patient Rights
  • New Obligations for Business Associates

Go through here for detailed rules