Medical Devices
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4-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
Duration: 4 Hours
Presenter: MICHAEL ESPOSITO -
4-Hour Virtual Seminar on Statistical Process Control
Statistical process control (SPC) is a form of feedback process control that does for discrete products what automatic process control does for the chemical process industry. Its purpose is to distinguish special or assignable causes from random or common... -
4-Hour Virtual Seminar on Write SOP’s and Work Instructions that Really Work
This seminar will discuss how to transform your regulatory documentation process into a profit center, an operational force multiplier in how you run your business and the functions comprising it. Writing Standard Operating Procedures and Work Instructions is technical... -
4-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance
This seminar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could... -
510(k) and PMA Refuse to Accept Policy
This webinar will overview the important critical content of these two revised documents to include the most important checklists that are contained in the Refuse to Accept Policy guidance that provides acceptability criteria for each 510(k) – Traditional, Abbreviated,... -
510(k) Third Party Review Program – Latest Guidance, Changes, Challenges, and Opportunities
This webinar will examine the FDA’s latest draft guidance, “510(k) Third Party Review Program, Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations” and the important areas for regulated companies to focus in the... -
510(k) Update – How to Format Succinct and Comprehensive 510(k)s – 3 Hours Virtual Seminar
This seminar will discuss what to consider and how to prepare for premarket notification 510(k)s and submit to the FDA. The speaker will walk you through how to format a succinct and comprehensive 510(k) package to increase submission quality... -
510(k) Update and Medical Device Changes
This webinar will provide valuable guidance to regulated companies on latest 510(k) updates and in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S.... -
6-Hour Virtual Seminar on Adaptive Design for Clinical Trials
Duration: 6 Hours
Presenter: Elaine Eisenbeisz -
6-Hour Virtual Seminar on Biostatistics for the Non-Statistician
Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand... -
6-Hour Virtual Seminar on Computer System Validation for Cloud and COTS Applications
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices... -
6-Hour Virtual Seminar on GxP and the Quality System
GxP is the heart and soul of how we do business in regulated industries. GxP is a general abbreviation for the “good practice” quality guidelines and regulations. The “x” in the term stands for the various aspects of good... -
6-Hour Virtual Seminar on Project Management for Non-Project Managers
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject. It... -
6-Hour Virtual Seminar on Project Management in Clinical Research
This course is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles and project management strategies applicable to clinical research during the new drug development process. This course examines the concepts and applied... -
6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries
Pharmaceutical and Biotech laboratories use a multiple array of various gadgets, devices, analytical instruments and computerized systems on a daily basis. Qualification of equipment or ancillary systems are necessary to prove that all critical requirements work as intended and... -
6-Hour Virtual Seminar on Statistics for Process Control
This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products. The concepts and information presented will be mainly concerned with statistical process control: obtaining monitoring...
