Health and Medicine

Course "Governance and Change Control According to GxP/GMP Requirements " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics. Documentation is a critical tool for ensuring GxP/GMP compliance. In order to maintain documentation in GxP/GMP compliant manner, information governance should be developed and implemented. Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product…

A Risk Based Approach to IT Infrastructure Seminar 2018 Course "A Risk Based Approach To IT Infrastructure & Cloud Qualification, Compliance & Control" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to provide control and regulatory compliance. The consequences of the IT Infrastructure being out of compliance can result in the failure of an entire…

Overview: In today's competitive business climate, health care organizations and their business associates should be able to focus on growing their businesses and not worrying about HIPAA Compliance. Staying up to date on the newest health care information and acquiring new patients takes time. HIPAA compliance takes time. But both goals can be accomplished - in fact, a good compliance program can make you even more competitive because compliance helps protect and grow your business and sets you apart from your competitors. For example, knowing how to use social media and electronic communications within HIPAA rules is key to staying…

Training Options Duration: 60 Minutes Thursday, May 24, 2018 | 10:00 AM PDT | 01:00 PM EDT Overview: In this program Dr. Barkley provides detailed information on the specific nature of ADHD symptoms as revealed by clinical research so as to better inform the current diagnostic criteria for ADHD. He then reviews the various modifications necessary for updating the DSM criteria and making them more useful with special populations (girls, adults, etc.). He also addresses the changes that are still needed to improve these diagnostic criteria based on findings in the research literature. Dr. Barkley then addresses the issue of…

OVERVIEW The full FDA FSMA compliance date for all impacted shippers, carriers and receivers of human and animal foods is April 6, 2018. All training, food safety transportation plans and system improvements must be completed by that date. Retailers and restaurant operations must assure that carriers have a plan in place and are implementing according to that plan. This planning training is recommended for food carriers impacted by the rules. Over 64,000 U.S. companies are impacted by the requirements established by the 2011 passage of this FSMA rule. The last major set of rules requiring full compliance for large and…

Perfect for anyone who needs a formal first aid certificate or for anyone who wants to brush up their existing skills. This course is run by a fully qualified instructor and is perfect for businesses and members of the public who require formal first aid training. Each attendee will recieve a certificate that is valid for 3 years. On this course you will learn to give CPR, how to manage choking, injuries, heart attacks, diabetic emergencies and much much more. You will also learn about incident reporting and the correct way to stock and manage first aid kits. Time: 9:00…

This program will teach you to set specifications for drug substance and drug product,including use of release test data, long term stability, accelerated stability and special stability studies. The webinar will also cover changing specifications during lifecycle management. Areas Covered in the Session : >. Setting initial specifications >. How to use available data and justify specifications >. ICH specific recommendations will be discussed >. Information required to br submitted during the lifecycle >. Updating the specifications during developing and commercial phases Who Should Attend: >. Manufacturing Departments >. Supply Chain Departments >. Technical Operations Departments >. Quality Control Departments…

Conducted early in the process development cycle, the Failure Modes and Effects Analysis tool is used to identify risks and then adjust the manufacturing or service process to reduce the identified risks and improve quality. Attendees will learn practical application of Failure Mode and Effects Analysis (FMEA) as it is applied to product, process, or system design. Areas Covered in the Session : >. How to Manage designated personnel with the skills to conduct and complete an FMEA of products or processes >. Define types of FMEA’s >. The important benefits of FMEA >. Be familiar with components of FMEA…

Training Options Duration: 60 Minutes Wednesday, May 23, 2018 | 10:00 AM PDT | 01:00 PM EDT Overview: As defined by the Health Information Portability and Accountability Act (HIPAA), a Business Associate can be any organization or person working in association with or providing services to a Covered Entity who handles or discloses Protected Health Information (PHI) or Personal Health Records (PHR). With certain exceptions, a person or entity that creates, receives, maintains, or transmits PHI for a function or activity regulated by the HIPAA Privacy Rule for a Covered Entity is a Business Associate. The HITECH Act, a recent…

Overview: The plan must also include a hazard analysis, allergen analysis, factory profile, recall plan, supply chain controls, process preventive controls, sanitation preventive controls and other items. Why should you Attend: This "how to"webinar will lead you and your team through two planning options, the FDA preferred option and a more intuitive approach to planning. At the end of this webinar, your group should be able to sit down, divide up the work and get your plans finished in a couple of days. Areas Covered in the Session: FDA FSMA Preventive Control Planning Food Defense Planning Supplier Controls Allergen Analysis…

Overview: This program will teach you to set specificatons for drug substance and drug product,including use of release test data, long term stability, accelerated stability and special stability studies. Why should you Attend: Learn the recommendations of ICH for using testing and stability data to set specifications for drug substances and drug products including use of special stability studies. Learn requirements for changing specifiations through the lifestyle of the product. Areas Covered in the Session: Setting intial specifications How to use available data and justify spectifications ICH specific recommendations will be discussed Informaton required to br submitted during the lifecycle…

The 5th Annual AHA (Advanced Healthcare Analytics) Summit 2018 is returning to Boston, and bringing together again the top leaders and innovators in healthcare data, analytics and medical information for two days of insightful learning and collaborative discussion. At this dedicated forum, we will delve into how top healthcare organizations are revolutionizing the field and overcoming the challenges to leverage new and more advanced analytic capabilities to reduce cost while maximizing the quality and value of care to their patients and their community. Don't miss out on the opportunity to learn from real world case studies demonstrating how to gain…

This is your first and only opportunity to listen to the most advanced clinical case studies from Nektar Therapeutics and Amgen which explore the use of IL-2 to enhance the expansion and activation of the Treg cells. Delve deeper with expert insights from Roche and ILTOO Pharma to understand how IL-2 at low doses could selectively stimulate Treg cells. Identify yourself as a leader in this community and join the discussion exploring the challenges in translating a proof of concept in autoimmune therapies from animal models to clinic. This meeting will provide the platform for conversations to be had to…

Training Options Duration: 90 Minutes Tuesday, May 22, 2018 | 10:00 AM PDT | 01:00 PM EDT Overview: I will address specific litigated cases I have worked where the covered entity had to pay out nasty fines to the Federal government and high settlements to patients affected by inappropriate usage of the EMR system - I will also address situations where the covered entity DID NOT receive any fines or judgements (even in the event of a breach or malicious actions) due to the fact they were using the systems in a "compliant manner" I will also be addressing how…

Medical device companies face ever increasing scrutiny from the FDA and other regulators. Customers demand quality and safety. The business requires efficient and effective use of resources. Without proactive and timely metrics, a company is blind to the health of its quality system. This can lead to disaster for the company or, even worse, its customers. Areas Covered in the Session : >. How to create a balanced scorecard >. How to move from lagging to leading indicators >. How to use indices or profiles to create a more complete picture of performance >. Lack of transparency in quality/compliance data…

This event is designed for pharmaceutical, biotech and medical device professionals with responsibilities in the following areas: Product Recalls Patient Safety Product Safety Product Quality QA/QC Postmarketing Surveillance Quality Systems and Engineering Quality Compliance and Audits Complaint Handling Medical/Consumer/Regulatory/Clinical Affairs Product Complaints Compliance CMO Management Business Support Coordination Product Surveillance Clinical Operations Quality Compliance QA and Supply Integration Global Device Coordination This conference is also of interest to: Drug Safety and Complaint Software Companies Consulting Firms Law Firms Inbound Call Centers Urls; Brochure: https://go.evvnt.com/186644-1?pid=154 Booking: https://go.evvnt.com/186644-2?pid=154 Price Early Bird Pricing - Conference Only - Register by April 6, 2018: USD…

This event is designed for pharmaceutical, biotech and medical device professionals with responsibilities in the following areas: - Product Recalls - Patient Safety - Product Safety - Product Quality - QA/QC - Postmarketing Surveillance - Quality Systems and Engineering - Quality Compliance and Audits - Complaint Handling - Medical/Consumer/Regulatory/Clinical Affairs - Product Complaints - Compliance - CMO Management - Business Support Coordination - Product Surveillance - Clinical Operations - Quality Compliance - QA and Supply Integration - Global Device Coordination This conference is also of interest to: - Drug Safety and Complaint Software Companies - Consulting Firms To this: Each…

The Chronic Kidney Disease Drug Development Summit is industry’s first end-to-end drug development networking and discussion forum, dedicated to overcoming challenges drug developers face in developing chronic kidney disease therapeutics more efficacious than the current standard of care. Developed in combination with experts from Boehringer Ingelheim, Bayer, Astrazeneca, Johnson & Johnson and many more, this industry focused forum focuses on lessons learnt from CKD drug development failures, molecular understanding and reclassification towards comprehensive precisions medicine and the potential of next generation therapeutics to deliver efficacy above and beyond angiotensin converting enzyme (ACE) inhibitors and ALT1 receptor antagonists (ARBs). Be part…

As the demand for information outside of approved labeling continues to rise, the FDA has been called by the industry to provide guidance that governs off-label communications. The regulatory landscape that monitors this space is often blamed for limiting the amount of information received by patients and restricting their ability to make well-informed decisions. Given the public health issues at stake and the public interest involved, it is imperative that this event details the importance of the timely communication of truthful scientific information that currently challenges pharmaceutical, biotech, and medical device professionals. The 2018 Off-Label Regulatory Compliance Congress also explores…

During clinical trials, inspections provide a framework to ensure quality and integrity of care, data and drug performance. As sponsors of clinical trials, it is important for pharmaceutical companies to ensure GCP guidelines are upheld by implementing inspection readiness. These inspections, often conducted by the FDA, EMA, MHRA and other regulatory authorities, all have unique regulations and caveats. These nuances mean that becoming — and remaining — inspection-ready can be a difficult, time-consuming battle. Because inspections can occur without notice, sites must be prepared for visits from many different stakeholders over the course of a clinical trial. Join the 4th…