Health and Medicine

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 Be freed from the outdated, now deficient, medical model of care planning.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…

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…

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…

This conference is designed for professionals from health systems, pharmaceutical companies and device manufacturers with responsibilities in the following areas: - Patient Experience (PX) - Customer/Patient Care - Patient Engagement - Customer Experience (CX) - User Experience (UX) - Marketing/Marketing Communications - Consumer/Customer Insights - Clinical Education/Staff Development - Public Relations (PR) - Human Resources (HR) - Community Relations - Patient Navigation - Patient Experience Design - Patient Advocacy - Patient Safety - Patient Liaison - Patient Services - Nursing - Product/Program Management - Customer Strategy - Customer Centricity - Market Access - Customer Excellence - Digital Marketing - CHRO…

The 2nd Patient Experience Conference will provide an exploratory view into patient and customer experience strategies while serving as an ideal meeting and networking place for leaders to collaborate on common challenges. This event will focus on strategies, and key on how to integrate the patient experience into organizational culture and daily business. It will also strengthen your strategy on Patient Engagement and how to best incorporate the patient experience into drug development process. You will learn from leaders in the industry and obtain better practices to bring back to your organization. Join us for engaging sessions on analyzing patient…

The Original Emergency Medicine Boot Camp course has been designed by a nationally recognized emergency medicine faculty to provide participants with the essential information needed to practice in a modern-day emergency department or urgent care center. In addition to the detailed clinical content, each presentation will emphasize key documentation and risk management concepts. The faculty consists of award-winning emergency medicine educators specifically chosen for their in-depth knowledge of emergency medicine, their ability to present information with passion and energy and their prior experience working in a collaborative environment. Instruction by a small, select cadre of award-winning Emergency Medicine educators/clinicians The…