Past Events (3,027)

Webinar On FDA’s Expedited Programs for Serious Conditions – Drugs and Biologics

September 12, 2014 from 1pm to 3pm – Online This webinar will discuss four FDA programs intended to facilitate and expedite development, review and approval of new drugs to address unmet medical needs in the treatment of serious and life-threa… Organized by compliancetrainings | Type: webinar
Webinar on Quality by Design (QbD) Across the Product Lifecycle

September 12, 2014 from 1pm to 2pm – Online As stated in Q8, the ICH guidance document on pharmaceutical development, drug product should meet its intended product performance as well as meet the needs of patients. Although the strategy for ph… Organized by compliancetrainings | Type: webinar

Webinar On FDA Regulation of Mobile Apps

September 11, 2014 from 1pm to 2pm – Online The use of mobile apps as a medical device continues to mushroom. Approximately 85% of adults use cellphones. They offer a fertile field for mobile apps used for medical purposes, some good, some no… Organized by compliancetrainings | Type: webinar
2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems at Washington DC

September 11, 2014 at 9am to September 12, 2014 at 6pm – Hilton Garden Inn Washington DC Downtown The Problem: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 a… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
Live In-Person Seminar on “GMP Compliance for Pharmaceutical Quality Control Laboratories” By Steven Kuwahara

September 11, 2014 at 9am to September 12, 2014 at 6pm – Melbourne, Australia Overview: This course is designed for people who are growing in their knowledge of pharmaceutical quality control practices and regulations. It will be a "how to" course where the instructor will exp… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda

Webinar On Medical Device Changes and the 510(k)

September 10, 2014 from 1pm to 2:30pm – Online This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(… Organized by compliancetrainings | Type: webinar

Webinar On Risk Management and Risk Analysis Techniques in Clinical Trials

September 8, 2014 from 1pm to 2:30pm – Online If you are currently involved in clinical trials either as a CRA, project manager, investigator or sponsor, this seminar will provide you with an overview of risk factors in clinical trials and possi… Organized by compliancetrainings | Type: webinar
Webinar on Current Good Manufacturing Practices (cGMP) for Medical Devices and IVDs

September 8, 2014 from 1pm to 2pm – Online The US Food and Drug Administration (FDA) states in warning letters “this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the… Organized by compliancetrainings | Type: webinar

Webinar On Statistical Analysis of Gages

September 5, 2014 from 1pm to 2pm – Online The seminar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios". Several of the stan… Organized by compliancetrainings | Type: webinar

Webinar On Current GMP Requirements for Combination Products - Final Rule

September 4, 2014 from 1pm to 2pm – Online As you know, medical diagnosis, technology, and treatment is very dynamic and is rapidly advancing. New discoveries are made that do not fit the "regulatory mold “and thus require new approaches to r… Organized by compliancetrainings | Type: webinar