EU Medical Device Classification – Webinar By GlobalCompliancePanel

Why should you attend : Today, medical devices occupy an extensive range of products that vary in intricacy and application. As the global market for medical devices continues to grow, it is important that companies be informed on the rules for classification of medical devices because of potential risk that can be associated with the device can have on the human body when used. This webinar will discuss the application of EU Council Directive on medical device classification.

Areas Covered in the Session

Basic definitions and purpose of medical device classification

How to carry out classification by reviewing the application and how to use the classification rules

Explanation of individual classification rules regarding non- invasive and invasive devises, along with additional rules applicable to active devices and other special rules

Who Will Benefit:

Quality Managers and Professionals

Marketing Managers and Professionals

Risk Managers and Investigators

R&D Project Managers and Team Members

Design Engineers

Consultants

Joy Frestedt, PhD, CCTI, RAC, FRAPS. Dr. Frestedt is the President and CEO of Frestedt Incorporated, a novel virtual Contract Research Organization network of over 50 experts and highly skilled staff meeting specific needs in regulatory, clinical and quality affairs. Dr. Frestedt has over 30 years of scientific, clinical and regulatory experience in the health care, pharmaceutical and medical device industries especially running clinical trials, conducting laboratory analyses and assisting firms with strategic decisions involving clinical research programs, regulatory strategies and the development of quality systems to compete globally. She has held key positions including vice president of scientific, regulatory and clinical affairs at BridgePoint Medical and Humanetics Corporation as well as key management positions with Johnson and Johnson’s Ortho Biotech, Medtronic, Mayo Clinical Trial Services, AstraZenca Pharmaceuticals and Orphan Medical. Dr. Frestedt holds a B.A. in biology from Knox College and a Ph.D. in pathobiology from the University of Minnesota Medical School and she is a member of the American Society of Clinical Oncologists, American Association of Pharmaceutical Scientists, American Society of Clinical Research Professionals and she is a Fellow of the Regulatory Affairs Professionals Society. Dr. Frestedt was named one of the “100 Most Inspiring People in the Life Sciences Industry (by PharmaVOICE, 2011) and one of the top 25 “Industry Leaders/ Women in Business Award (by the Minneapolis/St. Paul Business Journal, 2011).

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Pharmaceutical and Medical Device Good Manufacturing Practices Similarities and Differences

Why you should attend: As a quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms to the appropriate quality standards to meet customer and user needs. You are also aware that there is a paradigm shift from an emphasis on compliance to an emphasis on quality based systems. An understanding of this paradigm shift can be gained by comparing the compliance based Pharmaceutical GMPs with the Medical Device Quality System Regulation. ICH-Q7A will be included because it is a cross between the quality and compliance approach.

Areas Covered in the Session:

Who Will Benefit:

Howard enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA. His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.Wednesday, November 23, 201110:00 AM PST | 01:00 PM EST

The Power of Law And Its Practitioners

The judicial structure in India is of three tiered nature. The first step is the district courts which are situated in various districts of India. Delhi was recognized as a distinct legal entity by the Proclamation Notification no. 911 on 17.09.1912. By the proclamation it came under the management of Governor General of India in council. The first Chief Commissioner of Delhi became Mr. William Malcolm Hailey, C.I.E., I.C.S. After this, for enforcing the existing laws in Delhi, the Delhi Laws Act, 1912 was enacted.

Part V, Chapter IV of the Constitution of India establishes The Supreme Court of India as the highest judicial forum. It is the final court of appeal, situated in Capital of India- New Delhi. Supreme Court acts as the watchdog of our constitution. The Supreme Court deals with two kinds of jurisdiction: original jurisdiction and appellate jurisdiction.

Under original jurisdiction of Supreme Court falls, disputes between states, or union and states and petitions involving infringement of fundamental rights. It also takes up appeals against the judgments of High Courts.

The 1961 law minister Ashoke Kumar Sen, was instrumental in passing of the Advocates Act. The Bar Council of India is responsible for its administration and enforcement. According to this act, Bar council of India is the supreme body to regulate the legal profession in India. In addition to being professionals, advocates are also officers of the courts. A vital role is played by them in the administration of justice. Advocates Act thus is a set of rules which should bind the law bearers and remind them of the duty they have towards the court, their clients and fellow advocates. advocates in delhi also abide by these rules and regulations.

There is a two fold process for being entitled to practice in India. The first step is that the applicant must be a law graduate from a recognized institution. The lists of such institutions are maintained by Bar Council of India for which it maintains an Internal Committee. In the second step, the law graduate to qualify as an advocate has to qualify the enforcement criteria laid by the council. Thus all the delhi advocates have also gone through the same two fold process.

Apart from the central Bar Council of India, there exists in each state a separate Bar council. Advocates are to register themselves with the bar councils and have to observe territorial confinement. However, registration doesn’t restrict the advocates to appear in any court of India. Thus Delhi advocates can appear in Chennai high court or Guwahati high court.

In India, all advocates are recognized at the same level. Seniority is the basis of conferral of the title of senior advocate, which is on the basis of the duration of practice. Other factor affecting it is specialization in a particular field of law by the advocates. Apart from fame and status the Senior Advocates are requi8red to maintain higher standards of discipline, apart from some distinct rules. The senior advocates in Delhi also are bind to follow higher standards of conduct. Also they cannot interact directly with clients. From 2010 onwards lawyers are to pass the AIBE (All India Bar Exam) to qualify as an advocate. As a result advocates in Delhi, who passed from 2009-10 onwards have mandatorily passed the AIBE.

For an advocate to be appointed as a judge in high courts and Supreme Court, he/she must be having an experience of practicing law for at least ten years at high court or Supreme Court.

Get I-9 Compliance Help From Only an I-9 Attorney

Do you know that all employers now working in the United States of America must prove their identities and eligibilities? Yes, it has become a law according to The Immigration Reform and Control Act. This act also brings certain changes in the I-9 compliance form that must be known to all US employers. If it’s been several years that you have been running an organization with a good lot of employees on the US soils, you must have your I-9 compliance form ready having filled up correctly. Well, if you are not aware of The Immigration Reform and Control Act, you can always take assistance from an I-9 attorney.

When it comes to taking I-9 compliance help, an I-9 attorney can play a key role. Every US employer must be aware of the rules that have been made more rigid by the U.S. Immigration & Customs Enforcement (ICE). In this respect, these legal experts can help you understand all the laws and regulations of the act and make you aware of all such complications that might affect your employment status.

Moreover, one might face problems in filling up an I-9 compliance form. A slight error in the form can bring obstruction in the authentication proceedings. Therefore, I-9 lawyers will help you fill up these forms correctly and let you tackle any sort of legal issue with ease. Now, many employers might have questions as to why it’s necessary to seek for I-9 compliance help.

The Department of Homeland Security or the Department of Labor or the Office of Special Counsel for Unfair Immigration can approach anytime to check whether an employer is legally fit to run an organization. In this respect, it’s the I-9 compliance form that will act as the evidential document proving that you are an authenticated employer and allowed to work in the US. Therefore, I-9 compliance help is crucial that can keep you miles from any sort of hassle faced in the midst of the verification process.

Prior to contacting an I-9 attorney, it’s important for you to know about those who are eligible for I-9 compliance help. Those getting re-employment after three years from the actual date; those employed since November 1998 and serving the organization since June 1986; and those employed prior November 1986 and still working in the company. Once you have confirmed all these facts, you can now seek for I-9 compliance help from an attorney.