Health and Medicine

Certainly the most simplistic solution to achieving compliance excellence and 483 avoidances is “to do the right things right!” But what does this really mean? I have distilled the “doing the right things right” solution into 7 separate individual keys or actions that will provide a solid foundation for the establishment of any 483 avoidance program. Why should you attend this Webinar? Because as much as we try, most regulated industries don’t have a set approach for developing a compliance program that is integrated into the fabric of their organization that is targeted to avoiding 483s, that also serves real…

The United States Food and Drug Administration (FDA) regulates labeling and advertisement for prescription drugs and medical devices among other things. The advertising for nonprescription or over-the-counter (OTC) drugs falls under the jurisdiction of another federal agency. In pharmaceutical and medical device industry, firms and their representatives distribute or disseminate scientific or medical publications (e.g., journal articles or reference information or texts even including clinical practice guidelines) that discuss off-label uses (unapproved uses) of FDA approved or cleared drugs or medical devices to health care professionals or health care entities. It is imperative that firms stay in compliance with the…

This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. When used as intended, process validation can provide increased process reliability, improved yields, and reduced operating expenses. Areas Covered in the Session : Global Harmonization Task Force requirements (includes FDA and ISO) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Design Qualification Facilities and utilities Strategies for achieving a robust and reliable process. Typical process validation protocols Who Should Attend: Research and…

Changes in the FDA’s regulation of software makes life a lot easier for medical device manufacturers. FDA faced an overwhelming challenge when it started to develop a regulatory program beyond the basic Quality System regulation and the Software Guidance issued in 2002. Congress and FDA have made huge changes in FDA’s legal jurisdiction, and FDA has made dramatic revision of its regulatory program. FDA no longer regulates low risk software, premarket guidance documents must be revised or withdrawn, firms can give themselves 510(k) market clearance rather than FDA, firms can substitute requirement of Reports of Corrections and Removals by participating…

This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. This Medical device training will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company’s regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. Areas Covered in…

In 2014, the super-fast BM10k was added to the weekend schedule and immediately stamped its importance on the rankings with the second-fastest time in the country that year. The race starts from the same start as the Brighton Marathon in Preston Park. The course is fast and flat, taking participants through the city centre and finishing at the same finish as the Marathon, on Madeira Drive. Price: Individual Entry: GBP 27.5 Category: Sports and Leisure, Running Time: 9:00 am - 3:00 pm

With the US in the midst of an opioid crisis, it has never been more critical for the pharmaceutical, biotechnology and academic fields to unite in a common goal to innovate and accelerate the discovery and development of novel non-opioid therapies to treat pain. This summit and its expert speaker faculty will update you on the latest and novel RandD efforts currently ongoing in discovery and optimization of non-opioid analgesic targets and their mechanism of action. In addition, the inaugural Non-Opioid Pain Drug Development Summit will be your dedicated platform to overcome translational challenges such as animal model predictive value,…

This two and half day continuing medical education course will provide a multidisciplinary update from experts in their field focusing on prevention, evaluation, diagnosis, management, and treatment of benign and malignant breast diseases, high risk and survivorship issues. URL: Tickets: https://go.evvnt.com/234682-0?pid=154 Time: 7:00 am to 11:25 am Prices: MD, PhD, DO: USD 710.0, RN, PA, NP, Other: USD 610.0

Environmental Monitoring looks at the end results of the Environmental Control program – the microbiological and particulate quality of the clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs.” Why You Should Attend: This…

Eye 2018 takes great pleasure in welcoming all the attendees across the globe to take part in the “4th International Conference on Ophthalmology and Eye Disorders” coming live on November 01-03,2018 in London, United Kingdom. The conference revolves around the theme “Explore the Acumen of Ophthalmology” The Eye 2018 ensures a great platform for the participants around the globe to gain more exposure and knowledge about the emerging trends in the field of ophthalmology and eye disorders. The Eye 2018 conference will bring together various experts from the field of ophthalmology. Eye 2018 will keep you engaged with the seminars,…

The Heart Congress 2018 takes great pleasure in welcoming all the attendees across the globe to take part in the “heartcongress2018” held on November 19-20, in Paris, France. The Heart Congress 2018 ensures a great platform for the participants around the globe to gain more exposure and knowledge about the emerging trends in the field of cardiology. The conference brings together various professionals in the field of cardiology. The main goal of the conference to enlighten you with the latest discoveries in the cardiac medicine. The conference provides you a big opportunity to meet various cardiological researchers, cardiac surgeons and…

This webinar discusses methods for estimating process capability for both normal and non-normal data. Pre-requisites for estimating process capability (e.g. establishing process stability) are discussed first. Distributions are briefly described and methods for estimating ppm levels are presented. The use and limitations of common process capability indices (e.g. Cpk and Ppk) are discussed. It is vital that appropriate methods are used for estimating capability when the data is not well described by a normal distribution. Failure to do so often results in overly optimistic process capability estimates. Methods for testing for normality are discussed. Both transformations and distribution fitting are…

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence. Why Should You Attend: This course will address how to write effective correspondence and reports in support of your company's activities. Attendees will learn how to organize and deliver information for…

This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations. When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier’s acceptability is to audit the operation. Why Should You Attend: Many organizations conduct supplier audits because they are…

The Mayo Clinic Practical Proton Therapy Seminar and Workshop is designed to give radiation oncologists, medical physicists, dosimetrists, therapists, medical residents and physics residents, a focused interactive educational experience in implementing pencil beam scanning therapy. The seminar includes lectures on the basic principles of proton beam therapy, proton beam clinical trials, and practical discussions through case based vignettes with experienced proton beam faculty. The interactive workshop allows for faculty to share how proton beam therapy is implemented in our clinic with hands-on demonstrations of patient immobilization at CT simulation, treatment planning and evaluation, IGRT and beam delivery, including comprehensive QA.…

Psychology 2018 is an International Conference which is going to held on November 19-21, 2018 in Paris, France. This event aims to bring together leading professors, scientists, psychologist, psychiatrists, cardiologists, counselors, health educators, qualified nurses, social workers and physicians with the theme of exploring the advancements of psychology and its disorder. The core aim of the Psychological conference is to provide an opportunity for those who are all the part of the conference to meet, interact and exchange new ideas with the researchers and the international clients in the field of Psychology.

The principle substance of this Conference is to assemble awesome personalities in this field of Mental Health and Primary care in a fabulous gathering of fifth International Conference on Mental Health and Primary care which includes 16 tracts with 200+ subtracts that covers a wide report on emotional well-being. In which this field deals with many other branches and thus it has the interesting theory of Behaviourism, Humanism, Cognitive theory. Many psychiatrist are Health care providers. Worth your opportunity enjoying our random occasion present your dynamic papers and enroll yourself towards our blissful assembling in Edinburgh, Scotland. Salient Features In…

Cardiology 2018 is an extraordinary event designed for cardiologists and international medical health professionals to facilitate the dissemination and application of research findings related to cardiology and all the associated research areas. The conference invites participants from universities, clinical research institutions and diagnostic companies to share their research experiences on all aspects of this rapidly expanding field and thereby, providing a showcase of the latest techniques. 

The 50th Main Conference of the DDG will take place from 01. to 04.05.2019 in the CityCube Berlin. Spacious conference rooms, which not only provide space for lecture sessions, but also provide the working groups with the necessary refuges, and an ideal connection are strong arguments for this conference venue. The format of the conference has proven its worth in the meantime and in 2019 the focus will again be on plenary events with outstanding speakers on hot topics. Also relevant topics of the practice everyday life, to current developments of the dermatology and to occupational topics are treated. Courses…

The 8th Edition PFS and Injectables Summit will return to San Diego this September, helping you to translate innovation into commercial advantage. The device market is rapidly evolving; design thinking with a human factor approach and the adoption of new injectable formats are vital in keeping ahead of competition. Through practical case studies, the 2018 meeting will delve further into these hurdles, allowing you to assess and evaluate your options to drive device development: - Address the opportunities and challenges of device RandD progression: the shift from PFS to autoinjectors to wearables - Elevate your device usability and functionality through…