Past Events (3,027)

March 6Thursday

FDA's New Import Program Concerning International Consequences: 2-day In-person Seminar

March 6, 2014 from 6pm to 7pm – Orlando Airport Marriott Course Description: Importing products regulated by the FDA has become more complicated. The FDA is using increasingly strict criteria. In order to ensure that your imported product does not get deta… Organized by ComplianceOnline | Type: biotechnology, and, pharmaceutical
Trial Master File (TMF): FDA Expectations from Sponsors and Sites

March 6, 2014 from 10am to 11am – Online Event This training will review the essential elements of a TMF for clinical trials. The activities of set-up, maintenance, and monitoring will be discussed using case studies to highlight common deficienc… Organized by ComplianceOnline | Type: clinical
Establish Change Control for Pharmaceutical Stability Program

March 6, 2014 from 10am to 11:30am – Online Event This webinar on pharmaceutical stability program will discuss the types of CMC changes in the life cycle of a pharmaceutical product and how it affects the stability program. Why Should You Attend:… Organized by ComplianceOnline | Type: pharmaceutical
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices: 2-day In-person Seminar

March 6, 2014 at 8:30am to March 7, 2014 at 4:30pm – Double Tree San Diego Downtown Course Description: Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, tha… Organized by ComplianceOnline | Type: life, science

March 5Wednesday

Webinar On - Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements

March 5, 2014 from 12pm to 1pm – Online This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insuffic… Organized by compliancetrainings | Type: online, webinar
Best Practices for Implementing an Adverse Event Reporting System for Medical Devices Including IVDs

March 5, 2014 from 10am to 11am – Online Event This training on Medical Device Reporting (MDR) requirements will provide attendees the best practices for implementing an adverse event reporting system for medical devices including in vitro diagno… Organized by ComplianceOnline | Type: medical

March 4Tuesday

Webinar On - The FDA 510(k): Q-Submission, Preparation and Submission

March 4, 2014 from 12pm to 1pm – Canada Description : This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission. … Organized by compliancetrainings | Type: online, webinar

February 27Thursday

Webinar On - FDA’s 21 CFR Part 11 Add-on Inspections

February 27, 2014 from 12pm to 1pm – Online Description : In December 2010 the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the add on’ surveillance inspections of the spo… Organized by compliancetrainings | Type: online, training
GMP Requirements for Validation and Re-Validation of Analytical Procedures

February 27, 2014 from 10am to 11am – Online Event This webinar will explain the cGMP and ICH validation requirements for analytical procedures and discuss key factors that would affect validation process of analytical procedures. It will review the… Organized by ComplianceOnline | Type: pharmaceutical
Post Market Surveillance for Medical Devices

February 27, 2014 from 10am to 11:30am – Online Event This 90-minute webinar covers all aspects of post market surveillance (PMS) for medical devices. It will direct you to the specific documents for the detailed information you need for an effective po… Organized by ComplianceOnline | Type: medical