Conferences provide a rostrum for academicians, scientists, clinicians, researchers and every individual associated with the pharmaceutical profession. A platform that keeps you updated with all the rules, regulations & guidelines to bring the best out of you.
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 to 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.
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.
Agenda:-
Lecture 1 - Introduction to Risk Management and Quality System Integration
Lecture 2 - Risk Management to ISO 14971:2012
Lecture 3 - Usability and Risk Management
Lecture 4 - Software Risk Management (IEC62304 / FDA software reviewers' guidance):
Lecture 5 - Software Risk Management (IEC62304 / FDA software reviewers' guidance):
Lecture 6 - Safety / Assurance case
Why you should attend:-
The course will introduce the main elements of risk management with an 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 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 combined 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.
Who Will Benefit?
6-Hour Virtual Seminar on Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia, and Japan
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite the speed-to-market of innovative products and assist patients needing access to life-saving products and technologies. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable.
One such example is the Medical Device Single Audit Program [MDSAP], where Authorized Organizations would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia, and Japan. Health Canada has now made the MDSAP process mandatory for all licensed products in Canada.
Learning Objectives:-
Agenda:-
Why you should attend?
This 6 hrs webinar is focused on understanding the Medical Device Single Audit Program, the scope of the program, how to apply, the Authorized Organizations, the rating system developed, and what you can expect when signing onto the program. The webinar will discuss how such audits are organized, what to expect during an MDSAP audit, how does this differ from a typical certified body audit, along with document movement and timeline expectations in receiving the facility’s certificate.
Highlights of the key Regulatory Requirements for Medical Devices will also be covered for the participating MDSAP Countries of the U.S., Canada, Brazil, Australia, and Japan.
Who Will Benefit?
Product Shelf Life: Stability Study through Various Models to Estimate Shelf Life of a Product
Manufacturers of foods, drugs, consumer goods, and other products must determine the shelf life of their products so that customers know when the product can be expected to perform as intended. Expiry dates based on unsubstantiated shelf-life claims can introduce significant risk to a company’s success and reputation. Many approaches are available to quantify the "shelf life" and the method(s) chosen often will depend on the testing time available.
Join this session by expert speaker Steven Wachs to determine the steps required to set-up a stability study as well as understand the results which will estimate the shelf life of a product. The session will be using regressing models that will help in modeling the relationship shared between the response variable(s) and the time. Also, other models that are useful in describing non-linear degradation over time as well as methods to handle non-normal response data will be discussed. You will finally learn how to use accelerating variables which will be used to shorten the study time and the models. The webinar also includes various examples to illustrate the models discussed, in a better and more understandable way.
You will understand various useful techniques and methods in this webinar that are used to conduct the analysis of resulting data and stability study to estimate shelf life. It is easy for you to understand and immediately apply this learning. There will be stress on the interpretation and communication of results.
Webinar Objectives:-
Many companies struggle to determine statistically valid shelf life estimates that are needed for establishing expiry dates on products. Common issues include:
Webinar Agenda:-
Webinar Highlights:-
Who Should Attend?
The EEOC enforces workplace anti-discrimination laws, including the Americans with Disabilities Act (ADA) and the Rehabilitation Act (which include the requirement for reasonable accommodation and non-discrimination based on disability, and rules about employer medical examinations and inquiries), Title VII of the Civil Rights Act (which prohibits discrimination based on race, color, national origin, religion, and sex, including pregnancy), the Age Discrimination in Employment Act (which prohibits discrimination based on age, 40 or older), and the Genetic Information Nondiscrimination Act. Note: Other federal laws, as well as state or local laws, may provide employees with additional protections.
Title I of the ADA applies to private employers with 15 or more employees. It also applies to state and local government employers, employment agencies, and labor unions. All nondiscrimination standards under Title I of the ADA also apply to federal agencies under Section 501 of the Rehabilitation Act. Basic background information about the ADA and the Rehabilitation Act is available on EEOC's disability page.
The EEO laws, including the ADA and Rehabilitation Act, continue to apply during the time of the COVID-19 pandemic, but they do not interfere with or prevent employers from following the guidelines and suggestions made by the CDC or state/local public health authorities about steps employers should take regarding COVID-19. Employers should remember that guidance from public health authorities is likely to change as the COVID-19 pandemic evolves. Therefore, employers should continue to follow the most current information on maintaining workplace safety. Many common workplace inquiries about the COVID-19 pandemic are addressed in the CDC publication “General Business Frequently Asked Questions.”
The EEOC has provided guidance (a publication entitled Pandemic Preparedness in the Workplace and the Americans With Disabilities Act [PDF version]) ("Pandemic Preparedness"), consistent with these workplace protections and rules, that can help employers implement strategies to navigate the impact of COVID-19 in the workplace. This pandemic publication, which was written during the prior H1N1 outbreak, is still relevant today and identifies established ADA and Rehabilitation Act principles to answer questions frequently asked about the workplace during a pandemic. It has been updated as of March 19, 2020, to address examples and information regarding COVID-19; the new 2020 information appears in bold and is marked with an asterisk.
On March 27, 2020, the EEOC provided a webinar ("3/27/20 Webinar") which was recorded and transcribed and is available at www.eeoc.gov/coronavirus. The World Health Organization (WHO) has declared COVID-19 to be an international pandemic.
Areas Covered:-
COVID-19 has changed America ---and American business and educational institutions --- for the foreseeable future. And perhaps forever. The changes are many, some predictable, others unexpected, and even surprising. One impact, perhaps expected by the experts but surprising to many businesses and universities, is the dramatic shift in U.S. work-related visa policies.
The alert observer perhaps saw it coming. Since the onset of the Trump Administration in 2017, a series of Executive Orders sought to limit travel and immigration into the United States by citizens of selected, specific countries. New Department of Homeland Security regulations, that thus far has survived Supreme Court scrutiny, exclude would-be immigrants whose financial status suggests future dependence on social services. And, in 2019, immigration attorneys were detecting negative alterations in the way L-1 visa holders were being treated at the Canadian border.
Mid-way through the pandemic shutdown of non-essential businesses, President Trump issued an executive order, restricting entry into the U.S. of H-1B and L-1 worker- visa holders. The order expired on June 22nd … and was immediately succeeded by a new Executive Order extending the restrictions through the remainder of the calendar 2020.
The new, longer-lived Executive Order impacts not only H and L visas but also J visas awarded to au pairs, summer-season employees, and other temporary workers. Meanwhile, the U.S. Supreme Court in a 5-4 decision penned by Chief Justice Roberts stunned the White House with its mid-June ruling that the rescission of the DACA program by yet another executive order was improper and unenforceable. The fate of the hundreds of thousands of Dreamers is now back in the hands of the Administration and the Congress, precisely when the June 22nd Order signals a protectionist policy toward American jobs.
Join Attorney Jim Castagna, as he brings his decades of experience with student and employee visas to bear on these latest developments and offers prescriptive measures aimed at helping businesses, institutions, and organizations to cope with the “new normal” in the visa arena.
Session Highlights:-
Why You Should Attend:-
By attending this webinar, you will get to know that would you still be able to recruit international students straight out of college. You will also learn how harder it is going to demonstrate that your H-1B applicants have the specialized technical skills necessary to qualify. The webinar will also cover: Is USCIS changing the definition of the employer-employee relationship and minimum salary requirements for the H-1B and Is USCIS seeking to force outsourcing out of the H-1B market. Also, you will get to know that how does the USCIS plan to make it harder for my multi-national corporation to transfer foreign executive to U.S. operations.
Who Should Attend?
Schools Are Opening! How Does it Impact the FFCRA Emergency Paid Leave! How Does the Department of Labor (DOL) Clarify the Confusion?
With kids going back to school, new questions regarding eligibility for paid leave under the Families First Coronavirus Response Act (FFCRA) are cropping up. Many employees are confused about the way forward on how they can still be eligible for the Emergency Family and Medical Leave Expansion Act (EFMLEA) as they struggle with COVID-19 decisions.
The FFCRA, which remains in effect until December 31, 2020, requires employers to provide all employees with two weeks (up to 80 hours) of paid sick leave for one of the specified reasons related to COVID-19. Relevant here is that the employee is entitled to two weeks of paid sick leave at two-thirds the regular rate of pay when the employee is unable to work due to a bona fide need to care for a child (under 18 years of age) whose school or child care provider is closed or unavailable for reasons related to COVID-19. However, employees may take up to two weeks of paid sick leave for any combination of qualifying reasons, so tracking leave and the reason(s) for the same is key.
In the spring, questions regarding the need to stay home with kids whose schools were closed were clearer because, for the most part, schools were either closed or operating remotely. Things this fall are a bit more complicated with staggered school schedules, options for students to attend in person or to participate remotely, and continuing uncertainty about reopening or staying open for in-person attendance.
Areas will be covered during the Session:-
Who Will Benefit:-
It is critical for all Healthcare facilities to do their due diligence to research when red flags suggest a physician’s past behavioral problems. Identifying prior unacceptable and disruptive physician conduct is a must during the credentialing process. There can be challenges surrounding the peer review process when a physician with staff privileges is alleged to have engaged in unacceptable behavior. Physicians exhibiting disruptive behavior often defend their conduct as being done out of concern for patients. However, a physician’s disruptive conduct can have an adverse impact on overall patient care and/or safety. Further, the Joint Commission requires facilities to address disruptive behavior by physicians and other staff members to gain and maintain accreditation. You need to understand the impact of disruptive physicians and what protocol should be followed to anticipate and minimize liability due to physician lawsuits, claims of poor quality of care, and claims of negligent credentialing.
Areas Covered in the Session:-
Life is Naught But a Measurement of Time – You Cannot Waste One Without Losing the Other.”
Time & Life are the Same Things! ... SO, Time is Your MOST Valuable Resource.
Learn how to Save YEARS of Your Life using our Cutting-Edge Techniques ... We have Trained over 64,000 Students in 11 Months!
Areas Covered in the Session:-
BENEFITS OF TIME MANAGEMENT:
Learn Today ... and have MORE Time Tomorrow for Family, Friends, Fun and to just Relax & Enjoy Life!
Having Excellent Time Management Skills is one of the KEY Ways you WIN at the Game Of Life!
PS - Study This Course Carefully … And You Will Have An Unfair Advantage For Life In Virtually Every Area Of Your Life … Amazing!
Why should you Attend?
You Will Discover:
Who Will Benefit?
