A guide to practical Risk Management [ISO14971 and IEC62304]

Risk management being a mandatory component of almost any activity in the medical device industry.

Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.

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To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the ‘Safety Case’ or ‘Assurance Case’ document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.

Risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management being a mandatory component of almost any activity in the medical device industry.

The course will emphasize the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management as well as the increasingly important software and usability related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden. To make the combines effort to design, implement and verify a safe device transparent the concept of an assurance case will be introduced.

The course is mainly based on international consensus requirements such as ISO14971, IEC62366 and IEC62304. It will cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner’s perspective.

Following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Project managers
  • Design engineers
  • Software engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Medical affairs
  • Legal Professionals

How the Things Will Change The Way You Approach [Phase I Gmps]

Including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.

This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

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So, that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.

  • Directors
  • Managers
  • Supervisors in Regulatory Affairs
  • Manufacturing
  • Quality Assurance, and Clinical Operations

Auditing Analytical Laboratories for FDA Compliance

The social interactions that must be expected, the nature of the regulatory requirements and the nature of work that the laboratory performs will be discussed.

There are two phases to this topic. The first is auditing itself. Good audits are well structured. They must consider the reasons for the audit, the regulatory requirements, as well as the nature of the laboratory being audited. We will discuss the considerations that must be made when auditing a laboratory. The social interactions that must be expected, the nature of the regulatory requirements and the nature of work that the laboratory performs will be discussed.

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The second phase considers what must be considered during the audit itself. Audits conducted by inexperienced or ignorant auditors are often worthless, wasting the time and money of both the auditors and the laboratory being audited. Auditors who are familiar with laboratory operations are needed as it is easy to be fooled into thinking that a non-compliant laboratory is operating normally. Different types of laboratories will require different auditor/specialists. We will discuss the pitfalls that auditors can fall into, and what questions laboratories may expect to encounter.

It is necessary for a company to know if an analytical laboratory is capable of operating in compliance with GMP or other regulations. This is especially critical if the laboratory is a quality control laboratory whose test results will be used to support the release of a product to the public or to support and application for permission to market a product.  The failure of a quality control laboratory to comply with regulations can result in the failure of a request for permission to market a product or a forced recall of a marketed product.

In extreme cases a revocation of the permission to market a product may be the result. In any case the inability to conform to regulations will result in a loss of confidence in the ability of the manufacturer to produce a product that meets quality and regulatory requirements, and, in turn, lead to a refusal to purchase a product.

It is critical that the audit of the laboratory be conducted in a professional manner, as a poor audit will waste money and lead to a false confidence in the abilities of the audited laboratory whether it is internal or external to the company.

  • Potential Auditors
  • Supervisors who must initiate Audits
  • Laboratory Supervisors and Workers
  • Quality Assurance and Control Supervisors and Lead Workers
  • Supervisory Management who must select Contractors
  • Managers
  • Directors
  • Vice Presidents who Supervise Quality Assurance
  • Quality Control
  • Regulatory Affairs Groups

Top benefits from this

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

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

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.

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

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.

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

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.

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