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

An FDA inspection can be a stressful and challenging experience. This webinar will help you understand the basics of FDA inspections so you can be well prepared. We will discuss how to prepare for an inspection, what to do during an inspection as well as common mistakes to be avoided. Objectives of the Presentation: >. Understand the basics of an FDA Inspection >. Creating an inspection preparedness plan >. Preparing your team and SMEs >. Checklists for preparedness >. How to manage an inspection at your facility Areas Covered in the Session: >. General Information about Inspections >. Common mistakes…

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 >.…

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…

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…

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…

Epigenetics Congress 2018 invites all the participants from all over the world to attend 5th World Congress on Epigenetics and chromosome during October 25-26, 2018, Istanbul, Turkey. The principal objective of this congress is to provide a platform for cutting-edge research in epigenetics and chromosome. Through energize sessions and plenty of networking, you will learn to be more brave and audacious than you are now and free to develop your mind, increase your business, and change your bottom-line in positive way. Epigenetics defined as the study of the epigenotype, which deals with the study of the properties of the pathways…

This three-day course will provide the attendee with a multidisciplinary review of standard of care management practices and state-of-the-art advances in care of the patient with cutaneous melanoma. The first day will focus on epidemiology, prevention, pathology, surgical treatment and advances in systemic therapy for patients with melanoma. There will be breakout sessions focused on surgery, medical oncology and introduction to dermoscopy. The last two days are an in-depth immersion into dermoscopy for imaging of melanocytic and nonmelanocytic skin lesions. Participants will develop practical skills that will enable them to be more comfortable approaching patients with atypical skin lesions. This…

Dr. Scott W. Atlas and Dr. Peter M. Som will discuss over 500 selected brain, spine, and head and neck cases in this intensive, personalized tutorial, highlighting their approaches to the differential diagnosis of these diseases. Drs. Atlas and Som will also review pertinent normal anatomy, physiology, pathophysiology, and imaging concepts. The emphasis will be on a clinically oriented imaging approach that helps refine differential diagnosis. This is a unique experience for registrants to personally discuss cases with the authors of the preeminent texts books on Neuroradiology and Head and Neck Imaging. The course will encourage an open dialogue with…

Vom 15. bis 17. November 2018 findet der 15. AIO-Herbstkongress „Update Medical Oncology“ im Hotel Pullman Berlin Schweizerhof statt. Wie schon in den vergangenen Jahren steht der Kongress ganz im Zeichen der klinischen Forschungsarbeit des Themenbereiches der soliden Tumoren und der Translationalen Forschung. Der AIO-Herbstkongress wird inhaltlich von den Arbeits- und Studiengruppen der Arbeitsgemeinschaft Internistische Onkologie in der Deutschen Krebsgesellschaft (AIO) gestaltet und befasst sich schwerpunktmäßig mit dem wissenschaftlichen Update dieser Studienaktivitäten. Das Format des AIO-Herbstkongresses mit seinen Plenar- und Gruppensitzungen, Symposien und Diskussionsrunden hat sich bewährt, was nicht zuletzt durch steigende Teilnehmerzahlen und eine umfangreiche begleitende Industrieausstellung deutlich wird.…

Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements…

Overview: Medical Device Recalls are an effective method of removing or correcting consumer devices that are in violation of laws administered by the Food and Drug Administration. Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from devices that present a risk of injury or gross deception or are otherwise defective. Why should you Attend: Recall of medical devices that present a hazard to consumers protects your firm from more severe action by the FDA (or other regulatory agencies). Not performing a recall correctly van lead…

Overview: Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood. You'll come away with an actionable understanding of: Developing and creating buy-in for a project validation plan Understanding what the FDA accepts as an appropriate documentation model Beyond just in-product software V&V - understanding FDA's expectation for your testing software, ERP software and more When and how to use DQ, IQ, OQ, PQ or their equivalents How GAMP 4/5 requirements fit…

Overview: The U.S. Department of Agriculture's Office of the Inspector General reported recently that they have failed to review required documents for products labeled as "organic". This finding and report means a lack of controls at U.S. borders increases the likelihood that nonorganic products are entering the U.S. under "organic" labels. But importing fraudulent organic products is the tip of the iceberg with some imports showing "organic" on the labels when contents are adulterated with GMO, pesticides or are blatantly non-organic. Indeed, the difference in pricing between organic and non-organic products continues to increase in the face of consumer demand…

Overview: It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection. The session will also include an update on the proposed further major revision of ICH GCP R2 planned by ICH to start later next year. The new guideline includes a number of "hot" GCP inspection topics which are also covered in a number of other EU and FDA guidelines and documents, such as…

Overview: Medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug "active pharmaceutical ingredients" to achieve the clinical therapeutic effect. The medical device professional will often take the lead role in overseeing all aspects of regulatory & quality compliance, including CMC aspects, particularly when the "primary mode of action" relates to the device component. Regulatory and Quality engineers are often ill-equipped to manage CMC aspects of projects because they not possess even the basic understanding of the chemical, molecular structural, drug manufacturing process and analytical methods associated with…

Overview: Webinar focuses on reliability of processes and five problems all business organizations are affected with in daily operations. Problems include: Confusion Conflict Complexity Chaos Cost Traditional methods used to improve effectiveness of organizations processes are ineffective,95% of changes made by management today makes no improvement.Reasons are discussed and effective alternatives are presented in webinar. Why should you Attend: WHY: to increase internal, external customer satisfaction and increase organization's financial results. FUD: is defined as a disinformation strategy (false information spread deliberately to deceive). Webinar presents participants methods to identify and avoid confusion, conflict, complexity, chaos and excessive cost that…

CannaTech is an outstanding live event experience that showcases the full spectrum of global industry leaders, spanning the fields of science, research, finance, medicine, government policy, tech innovation, agriculture & entrepreneurship, with a special focus on medical cannabis and all the opportunity that surrounds it.

Lectures and cases will cover evidence-based practice techniques and protocols for improved diagnostic accuracy in multiple applications. At the conclusion of this activity, participants should be able to: ~Apply advanced techniques and protocol design in CT, MRI, ultrasound, and Interventional Radiology ~Integrate state-of-the-art imaging techniques and applications into clinical practice. ~Utilize advanced MDCT for abdominal imaging. ~Describe recent advances and techniques in musculoskeletal imaging. ~Apply quality improvement strategies to the practice of interventional radiology, with a focus on increasing efficiency, communication, and collaboration. ~Describe the common challenges in interpreting PET/CT. ~Describe thoracic radiologic procedures for clinical cancer management. ~Optimize imaging…