Health and Medicine

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. Areas Covered in the Session : >. Why audit your supplier? >.…

Antibody Engineering And Therapeutics Europe, 05-07 June 2018 in Amsterdam, is brought to you by the same organizers of the trusted Antibody Engineering And Therapeutics conference in the US, and in conjunction with The Antibody Society. This event is the #1 antibody meeting in Europe bringing together world-renowned scientists and academic researchers to deliver the latest science, technologies and partners needed to help you accelerate next generation antibodies towards commercial success. Prices: Industry - Conference + 2 Workshops: GBP 2099 Industry - Conference + 1 Workshop: GBP 1899 Industry - Conference Only: GBP 1499 Vendors - Conference + 2 Workshops:…

Training Options Duration: 90 Minutes Tuesday, June 5, 2018 | 10:00 AM PDT | 01:00 PM EDT Overview: Anxiety is one of the most common reasons clients seek mental health services. However, anxiety disorders can be especially difficult to treat, and oftentimes professionals note that many clients seek treatment for years with minimal relief. This topic teaches professionals the basic neuroscience behind anxiety, and explains why traditional methods are often necessary, but not sufficient, for recovery from anxiety. Additionally, this content presents an easy-to-follow roadmap for anxiety treatment and presents several examples of techniques that have been shown to help…

Overview: This session sets the context for the off-label promotion of medical products starting with early history and moving to the most recent history of FDA's decision on guidance documents. Why should you Attend: This session will discuss comments from industry, health care providers, health care insurers and other concerned parties. The latest legal considerations, decisions and conclusions will be discussed as well as future expectations for off-label promotion of medical products. Who Will Benefit: Quality Managers Quality Engineers Regulatory Affairs Regulatory Attorneys Doctors Health Insurance Speaker Profile: Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees…

Overview: This one-day seminar will be addressing how a Business Associate needs to comply with HIPAA and when it applies. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, as there is so much misleading information regarding the do's and don'ts with HIPAA. I want to add clarity for Business Associates, and also help businesses comply. Not only is this necessary due to the requirements of HIPAA but also to satisfy many customers who require much more these days than just signing a Business Associate Agreement. Times have…

OVERVIEW This insightful session will give you clarity on medical decision making versus medical necessity. What things are auditors looking to find when your records are being reviewed? How can I work with my clinician/physician to improve his/her documentation? Medical necessity means more than just "fluff" in the medical record. We will discuss how to justify the physician's care plan and avoid take backs from third party payers. WHY SHOULD YOU ATTEND It is vital for the entire care team to take part in adapting to the rules that we must follow when it comes to justifying the medical necessity…

Product Format: Live Webinar Presenter(s): Norma Skolnik Conference Date: Tuesday, June 05, 2018 Aired Time: 1:00 pm ET | 12:00 pm CT | 11:00 am MT | 10:00 am PT Length: 60 minutes Price: $227.00 Despite the prohibition of marijuana use at the federal level, the cannabis industry is growing rapidly. And keeping up with constantly-changing state-specific regulations can be overwhelming. Don’t get lost in the puzzle of state versus federal law. If you want to promote cannabis without violating federal and state laws, join this webinar by industry veteran Norma Skolnik. You will learn what you need to know…

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…

Failure Investigations (FI) and Root Cause Analysis (RCA) are vital elements of a robust, “bullet-proof”, “closed-loop” Corrective and Preventive Action (CAPA) program, often required in product or equipment validations. Rigorous FI and RCA show a company’s Quality Management System to be proactive, and result in meeting / exceeding cGMP requirements and U.S. FDA expectations. Meaningful FI / RCA requires a specific sequence of activities, each building on the other, to eliminate non-conformances, out-of-specification conditions, improve product quality, and most importantly, to enhance patient safety. Areas Covered in the Session : >. Robust non-conformance resolution system requirements >. Understanding Failure Investigation…

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…

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…