Health and Medicine

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…

NEW FOR 2018: - Explore and engage with the evolving industry of pharmaceutical manufacturing related to PFS, from cross-site development to navigating injection technologies through the design life-cycle - Assess quality control systems and risk-based control strategies for drug delivery devices - Consider the importance of Human Factors Engineering, from Rate of Return to the Design History File - Highlights on emerging trends of technologies and studies to assist device and drug formulation developers - Perceive the regulatory expectations from cross-border perspectives in the EU and US and what can we do to face these challenges Leading pharmaceutical speakers: -…

16th International Conference on Food, Biological, Healthcare and Environmental Sciences (FBHES-18) scheduled on June 4-5, 2018 at Bangkok (Thailand) aims to bring together leading academic scientists, researchers and scholars to exchange and share their experiences and research results about all aspects of Food, Biological, Healthcare and Environmental Sciences and discuss the practical challenges encountered and the solutions adopted. The International Refereed Conference Proceedings will be blind peer reviewed by two competent reviewers. The post conference proceedings will be submitted to be indexed in the SCOPUS/Thomson Reuters, CiteSeerX, Google Books and Google Scholar for possible Indexing. The printed conference proceedings book…

Mayo Clinic provides healthcare leaders an intensive, all-inclusive experience. Attendees will be immersed in both didactic and interactive experiences with Mayo Clinic leaders across patient care, research and education. Topics include the Mayo Clinic Model of Care and its integrated healthcare practice and demonstrations of the best-in-class Mayo patient experience. Attendees will learn from and network with innovative leaders in areas such as Individualized Medicine, Regenerative Medicine, Practice Innovation and Quality. A full schedule will be released at registration. Time: 7:00am - 5:00pm

Course "Learning Management Systems (LMS)" 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 will describe the development of job position curricula in the pharmaceutical industry using a Learning Management System (LMS) and provide you with the tools needed to create effective curricula. A Pharma curriculum is the sum total of all the courses that an employee in a specific position requires, and is composed of smaller groups of courses called modules. A curriculum typically will include a "core curriculum" (usually several modules) with all the…

Course "A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Following the initial development, the steps further continues thru optimization and subsequently to Validation, leading to the understanding of Validation Parameters and their generic definitions. Guidance from EP, USP, ICH Q2 (R)1, AOAC etc. will be discussed. The presentation continually builds on from a conceptual level to practical applications leading to data handling, Data Integrity, Validation Protocol and other…

Training Options Duration: 90 Minutes Monday, June 4, 2018 | 10:00 AM PDT | 01:00 PM EDT Overview: This lesson will be addressing how practice/business managers (or compliance offers) need to ensure their organization is complying with the Federal Substance Abuse and Mental Health Administration (SAMHSA) regulations (42 CFR Part 2) and how this differs from the HIPAA (Health Insurance Portability and Accountability Act) Privacy and Security Regulations. Both regulations carry significant civil and even criminal penalties if not complied with. Both regulations are now being enforced proactively by the Federal government. Both regulations if not complied with can lead…

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? >.…

Do you have health issues or symptoms that affect your ability to live your life fully? Have you been to the doctor to be told nothing's wrong with you OR been put on meds that make you sick? Me too! I was sick for over 10 years and spent tens of thousands of dollars to be told NOTHING WAS WRONG WITH ME! Maybe you did get a diagnosis and meds to take that make you miserable? Wishing for a better answer? That's why I'm producing this holistic health conference for you! Treat The Source is not just any holistic health…

In FDA-regulated industry, it is imperative that firms should be well aware of recent policy changes and understand what laws and regulations apply for FDA-regulated products on the US market (e.g., food, drugs, biologics, cosmetics and medical devices including in vitro diagnostics). Areas Covered in the Session : >. Laws and Regulations >. Recent FDA Policy Changes >. FDA Inspection Manuals >. FDA Inspection Types and Depth of Inspection >. How to Avoid Common Deficiencies >. Actionable Inspection Preparation and Management >. Communication with EQ Skills >. Employee Training >. Actual Case Studies >. Speaker’s PASS-IT Suggestions/Recommendations-Dos and Don’ts >.…