Conferences  >  Medicine & Healthcare  >  Regulation in Medicine and Pharmacology

FDAMap

SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.

FDA, SOPs, Quality Management System, Clinical Trials, Clinical Studies, Clinical Research, Clinical Development, FDA Regulation, FDA Complience

Pharmacology and Drug Development,    Translational Medicine, Clinical Trials

FDAMap

Each year FDA receives about 3000 applications for new devices via the 510k process, and about 60% of them are rejected either for poor quality application that cannot even be reviewed or for other technical reasons. Submissions to the FDA that are poorly organized, do not follow current practices, contain inconsistencies between documents, have missing or incomplete content, or poor structure will result in significant delays in the clearance process. With multiple review cycles, up to 90 days each, rejections by FDA could stretch the 510k clearance time-lines to 8 months or more. Most of the refuse-to-accept deficiencies are due to the inexperience of the 510k writers, who ignore the FDA rules. Writing and assembling a complete and well structured 510(k) submission will certainly improve the likelihood of FDA clearance on the first round.

This hands-on workshop is done by one of the industry’s top regulatory expert. The trainer has performed numerous reviews of 510(k) submissions over the last 15 years, and has analyzed the reasons that most often lead to delays in getting submissions ultimately cleared by FDA. This hands-on workshop will walk the attendees through the structure and key elements of the 510(k) submission and explains in clear language the most common pitfalls to avoid in the development of your 510(k) submission to the FDA.

FDA, 510 K Submission, 510 K Writers, FDA Compliance, FDA Regulations,

Pharmacology and Drug Development,    Translational Medicine, Clinical Trials

Infectious Disease Medicine,    Healthcare Systems and Hospital Management

Erst-und Nachschulung als Laserschutzbeauftragter für medizinische und kosmetische Anwendungen (Präsenzkurs) Der 1-tägige Laserschutzkurs zum Laserschutzbeauftragten für die Medizin und Ästhetik vermittelt die für den Umgang mit medizinischen Lasern der Klassen 3R, 3B und 4 notwendigen arbeitsschutz-und unfallschutzrechtlichen Fachkenntnisse. Mit dem erfolgreichen Kursabschluss wird gegenüber Behörden die gesetzlich geforderte Qualifikationals Laserschutzbeauftragter für medizinische und kosmetische Anwendungen nachgewiesen.

Der 1-tägige Refresher-Laserschutzkurs für die Medizin und Ästhetik frischt die für den Umgang mit medizinischenoder kosmetischen Lasern der Klassen 3R, 3B und 4 notwendigen arbeitsschutz-und unfallschutzrechtlichen Fachkenntnisse auf. Mit dem erfolgreichen Kursabschluss wird gegenüber Behörden der Nachweis über die alle 5 Jahre geforderte Fortbildung als Laserschutzbeauftragter erbracht.