Health and Medicine

Training Options Duration: 60 Minutes Friday, June 8, 2018 | 10:00 AM PDT | 01:00 PM EDT Overview: That childhood ADHD predisposes to increased risks for impairment in educational, family, peer, and eventual occupational functioning by young adulthood, among many other major domains of life activities is well established in research. Less appreciated is that the disorder also predisposes to increased health, medical, and dental risks, such as an increased risk for accidental injuries across the lifespan. And ADHD also predisposes to certainly personality traits and lifestyle choices that have a significant impact on these health related factors. Such risks…

Overview: It is essential for industry to employ efficient and accurate strategies for monitoring outsourced projects to minimize the chances of receiving warning letters from competent authorities. Companies should have robust structures in place for successful vendor selection, contract design, and quality monitoring and risk minimization when outsourcing activities in GXP areas to remain compliant. Areas Covered in the Session: Discover Tools and Processes to Manage CROs/other Vendors Gain an insight for CROs/other Vendors of what Sponsors Expect and how to Meet their Expectations Measuring CRO Performance including Metrics and Key Performance Indicators Managing and avoiding common pitfalls with CROs/Vendors…

Overview: This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity. Areas Covered in the Session: 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 Who Will Benefit: Quality Assurance Quality Control Laboratory Staff Managers GMP, GCP, GLP Professionals Speaker Profile: David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11,…

This training program will illustrate how these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Attendees will learn if they exist independently of each other or do they complement each other to enhance, build and provide a product. Areas Covered in the Session : >. How these two different concepts are integrated (Phase 1, 2,and 3 vs. Stages 1, 2, and 3) >. Where do they merge? >. Do they exist independently of each other? >. Do they complement each other to enhance, build and provide a…

Human Error occurs in all settings. In the world of pharmaceutical manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients. Human is a frequent occurrance in pharmaceutical manufacturing. It occurs even when every obvious preventive actions have been employed such as effective compliance documentation development and training. Areas Covered in the Session : >. Understanding Human Error >. Nature of human error in pharmaceutical manufacturing >. Approaches to investigating Human Error >. The root causes that are directly attributable to Human Error >. The role of leadership in Human…

Oxford Global is proud to present the 2nd Annual Microbiome Discovery and Development Congress, taking place on the 7-8th June 2018 in Berlin, Germany. The conference showcases world-class senior industry experts presenting case studies on the most exciting issues in the microbiome field, covering novel strategies in microbiome research, the latest therapeutic trends, and the challenges and opportunities involved in commercialising microbiome therapeutics. View Agenda: http://bit.ly/2BOsODK The congress will cover 2 areas focusing on: • Novel Strategies & Technologies for Microbiome Drug Discovery • Therapeutic Potential of the Microbiome • New for 2018! Workshop on commercialising microbiome therapeutics. Further sessions…

Der Psychiatrie und Psychotherapie Refresher findet vom 07. - 09. Juni 2018 in Köln statt. In kurzen, 30 – 40 minütigen Blöcken werden die neuesten diagnostischen und therapeutischen Leitlinien der Psychiatrie und Psychologie von Spezialisten präsentiert und auf Ihre Fragen eingegangen. Dabei wird vor allem auf Praxisrelevanz großen Wert gelegt. Unsere Referenten sind Experten in ihren Fachbereichen mit langjährer Erfahrung in ihrem Betätigungsfeld. Sie kommen aus renomierten Einrichtungen wie der Uniklinik Köln, der LVR-Klinik Köln und des Universitätsklinikum Heidelberg. Diese praxisorientierte Fortbildung bietet in über 24 Stunden: ein umfassendes Update für Psychiater, Psychologen und Psychotherapeuten ein Kursbuch mit den Power-Point-Präsentationen…

Dear colleagues, On behalf of the ESPD and the British Society for Paediatric Dermatology it is a great pleasure for me to Chair the Organising Committee of the 18th Annual Meeting of the European Society for Pediatric Dermatology (ESPD 2018), which will be held on the 7-9th of June 2018 in London, United Kingdom. The scientific programme is very exciting, with worldwide expertise in both the chairs and speakers selected. The meeting will feature two parallel sessions breaking for six plenary Keynote Lectures. London is a vibrant, multicultural City. The meeting will take place in The Queen Elizabeth II Conference…

SMi proudly hosts the Pharmaceutical Microbiology Conference, San Diego, USA on the 7th and 8th of June 2018. This is the second Pharmaceutical Microbiology Conference we have run with last year being a great success. The pharmaceutical microbiology field is relevant in almost all areas of pharmaceuticals. This Conference provides an opportunity for professionals within the field to update themselves on the revised regulations and newly emerging methods and practices. Join us in discussing the evolving issues facing the industry, such as: aseptic practice and contamination prevention, mycoplasma testing, water monitoring and biofilms. BENEFITS OF ATTENDING: • Take part in…

Overview: In this webinar, we will review CAPA as part of Quality Management System (QMS), reasons why organizations need to use CAPA, what is its purpose. We will describe CAPA concepts and procedures. We will also describe FDA investigation procedure of CAPA. Why should you Attend: Corrective and preventive actions both include stages for investigation, action, review, and further action if required. Implementation of corrective and preventive actions is the path towards improvement and effectiveness of Quality Management Systems. Learn CAPA as part of Quality Management System (QMS), its purpose, its concepts and procedures. Learn how FDA investigates CAPA in…

Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems for Bio-pharma, Medical Devices and Cosmetics Industries" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will…

Course "Managing Your FDA Inspection: Before, During and After" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions. If you understand FDA's management…

Training Options Duration: 60 Minutes Thursday, June 7, 2018 | 10:00 AM PDT | 01:00 PM EDT Overview: The session will provide an overview of the Anti-Kickback Statute (AKS) and review what it prohibits, as well as review the Statute's available safe harbors. It will also show how violation of the AKS can raise FCA concerns, and it will provide an assessment of enforcement activities, showing how participants may be at risk. In addition, the session will review recent cases and show how they potentially impact participants. We will provide an in-depth review of the AKS, focusing on what is…

Product Format: Live Webinar Presenter: Carmen Bowman Conference Date: Thursday, June 07, 2018 Aired Time: 1:00 pm ET | 12:00 pm CT | 11:00 am MT | 10:00 am PT Length: 90 minutes Price: $197.00 If you are still writing traditional, medical, institutional care plans, and if your residents are not driving their care plans, it is time to change course. Care plans belong to, and should reflect, the person. Be freed from the outdated, now deficient, medical model of care planning. In this session, industry veteran Carmen Bowman will cover culture change practices progressing from personalized to “I” care…

The Pharmaceutical and Biotech industries are going through tremendous changes that have been increased by the recent global financial challenges. The FDA is promoting the use of Quality-by-Design (QbD) as an approach for helping companies speed up development and improve their operations. In addition the FDAs new Process Validation Guidance promotes Continued Process Verification. Sampling is an essential element of both process and product development and continued process verification. Areas Covered in the Session : >. Principles for developing useful sampling plans and procedures >. When “Square Root (n)+1” is a valid sampling plan >. Creating a process sampling system…

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…

Flow Chemistry has been used in petrochemical and bulk chemical production for over 100 years but has only really been taken up in the Pharmaceutical and fine chemical industries over the last 10 years or so. This course aims to give an introduction to the subject and an overview of the current state of the art. A variety of chemical reactions in flow and how to translate a conventional reaction in to a flow process will be described. This also entails choosing the right type of flow reactor for the chemist and a number of different flow reactor systems, inline…

Der Allgemeinmedizin Refresher findet vom 06. - 09. Juni 2018 in Hamburg statt. Mit über 5.000 teilnehmenden Ärzten zählen unsere Fortbildungen im Bereich Allgemeinmedizin und Innere Medizin zu den beliebtesten Kursen im deutschsprachigen Raum. In kurzen, 30 – 40 minütigen Blöcken werden die neuesten diagnostischen und therapeutischen Leitlinien der Allgemeinmedizin von Spezialisten präsentiert und auf Ihre Fragen eingegangen. Dabei wird vor allem auf Praxisrelevanz großen Wert gelegt. Diese praxisorientierte Fortbildung bietet in über 30 Stunden: ein umfassendes Update für Allgemeinmediziner, Internisten und niedergelassene Fachärzte ein Themenreview für Assistenzärzte als Vorbereitung auf die Facharztprüfung ein Kursbuch mit den Power-Point-Präsentationen der Vorträge…

Course "How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Senior management takes responsibility for quality and GXP compliance. It is not something delegated to the quality unit or to the regulatory affairs group. Developing and implementing an effective inspection readiness plan will help ensure better results, as well as a less stressful Inspection. Planning strategically ahead will reduce document turn-around time, improve…

Training Options Duration: 60 Minutes Wednesday, June 6, 2018 | 10:00 AM PDT | 01:00 PM EDT Overview: Hospitals must file a National Practitioner Data Bank report on any physician's surrender of privileges if an investigation is underway. This has always been a Data Bank reporting requirement, intended to discourage plea bargains which allowed physicians to avoid being reported if they agreed to waive hearing rights. Under the new Guidebook, expanded descriptions of "investigation" and "surrender" stretch what is to be considered a reportable surrender of privileges. OPPE and FPPE and other peer review can be affected, as are physicians…