A second look at 510(k) changes
Overview: The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).Therefore, it is up to the sponsor/manufacturer to determine whether this change will be significant or not. T...
South Korea: Navigating the Clinical Tr...
Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceutical Products in South Korea. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in South Korea. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrati...
How Healthcare.gov Dared Greatly and Won
Today’s health insurance marketplace has come a long way from the cost sinkhole many predicted it would become. Healthcare.gov became the biggest challenge in Centers for Medicare and Medicaid (CMS) 50-year history. A year into development, Henry Chao, the Deputy CIO at CMS, made a daring decision to change course and adopt new technologies that effectively supported CMS’s modern marketplace initiative. Join MarkLogic and Carahsoft...
GMP Expectations for Products Used in E...
Overview: FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the Food, Drug, and Cosmetic Act. Thus the natur...
Best Practices for Effective Cleaning V...
This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in...
Webinar on SOPs for Clinical Trials: Re...
Overview:Since the year 2000 there has been an increasing trend of registered clinical studies from approximately 4,000 in 2000 to 160,000 in 2014. In 2014 Forbes Magazine reported that the FDA had approved 44 drugs the highest in 18 years.Why should you Attend: In clinical research, Standard Operating Procedures (SOPs) assist in defining the clinical groups standard practices and daily processes conducted to assure execution of research task...
Entry Control Facilities (ECF) Design
Similar to the Maintaining Control Workshop conducted by the US Army Surface Deployment and Distribution Traffic Engineering Agency, this workshop is intended for government, military and contractor SECURITY or ENGINEERING personnel involved in designing entry control facilities. The curriculum focuses on the design features required for the effective and efficient operation of access control points at installation perimeters and controlled ar...
Clinical Research for Cardiovascular Ph...
Understanding basic clinical research requires excellent people and project management skills, and very good scientific writing and organization skills. Also paramount is gathering necessary information to manage the statistical analysis and data management of all the many clinical studies. The clinical development plans must be laid by experienced leaders and project managers. The clinical plan includes the budgets and timeline necessary to p...
The Magic of Conflict
This high-energy, interactive program offers a new definition of conflict, a new way of looking at it, a new way of experiencing it, and a new way of responding to it. You will learn to practice conflict resolution through the use of film clips, real-life examples, tips, guidelines, role-plays, inquiries, and experiential exercises. In addition, you will be introduced to a unique communication model, which can serve as a guide to help you achi...
Sensitive Compartmented Information Fac...
After attending this unclassified Workshop, students will be able to oversee design and construction of a sensitive compartmented information facility (SCIF) which meets official government requirements for a secure area where classified information is handled. The stringent physical security requirements; such as, access control systems, thickness of doors, the strength of concrete and the use of alarms, and acoustical controls which prevent...
You must be logged in to view details.
Membership is Free!
Please enter your email and password:
Please sign in with your email and password:
LinkedIn is experiencing technical difficulties. Please log in via email and password. If you do not remember your password, please click "Forgot Password" to reset.
