2012 Events
Date | Type of Event | Description |
| January 27 | Class | The Essential Quality System Regulation Course |
History - 2011 Events
Date | Type of Event | Description |
| January 19 | Open Meeting | How not to ruin a perfectly good product with a perfectly flawed study design. |
| January 26 | Webcast | The Challenge of Developing a Regulatory Intelligence Network to Support Global Clinical Trials: Communication & Collaboration. |
| February 8 | RAC Study Group | Preparation for US RAC Exam - Study Group |
| February 16 | Webcast | FDA's New 510(k) Action Plan: Changes for 2011 |
| March 9 | Open Meeting | Tales from the Crypt: A Previous FDA Medical Device Investigator's Web of Real-life Inspection Stories |
| March 31 | Seminar | The Essential Quality System Regulation Course |
| April 1 | Seminar | CAPA Boot Camp |
| April 20 | Open Meeting | Navigating the Electronic Maze: Practical Advice for Companies |
| June 15 | Open Meeting | FDA Medical Device Regulations: An Overview for Beginners |
| August 17 | Open Meeting | Regulatory Chat Mixer |
| August 25 | Webcast | Complaint Handling |
| Sept 8 | Study Group | RAC Study Group Request for Volunteers |
| Sept 28 | Webcast | Surviving the FDA's New PREDICT Import Screening Program |
| Oct 19 | Open Meeting | Mitigating Risk in the Supply Chain Based on Regulatory Requirements |
| Oct 30 | Webcast | What needs to be in a product submission: An FDA Reviewer's Perspective. |
| Nov 14 | Webcast | Building a Better 510(k): Suggestions from Inside FDA |
| Dec 7 | Open Meeting | Annual FDA Update |
History - 2010 Events
Date | Type of Event | Description |
| January 11 | Special | Industry Speakers Needed! Sign up if interested by January 11. |
| January 12 | Webcast | CGMPs for Combination Products: An Interactive Analysis with Industry and FDA |
| January 20 | Open Meeting | Using CAPA to Strengthen and Improve Your Quality System |
| February 16 | RAC Study Group | Spring RAC Study Group |
| February 24 | Webcast | Auditing Suppliers and Contractors: Be Ready for Increased FDA Scrutiny |
| March 4 | Webcast | Statistics for 510(k) Submissions |
| March 10 | Open Meeting | Human Tissue and Tissue Products - An Overview of 21 CFR |
| April 6 | Webcast | Reimbursement in 2010 and Beyond: Understand the Changing Legal Landscape |
| April 12, 13 | Webcast | Medical Device Submission & Compliance Strategies |
| May 5 | Open Meeting | Complaint Handling - The "Big" Picture |
| June 8 | Webcast | SOPs; Advanced Problems & Solutions |
| June 9 | Dinner Meeting | FDA Submissions Roundtable |
| July 29 | Webcast | Maintaining a Complete Design History File |
| August 4 | Open Meeting | Electronic Submission Awareness |
| Aug 31 to Nov 2 | Study Group | RAC EU Study Group |
| September 2 | Webcast | 510(k)s: The 70 Changes FDA Wants |
| September 22 | Open Meeting | Process Validation - Current Regulatory Expectations |
| September 23 | QSR Class | The Essential Quality System Regulation Course. |
| November 3 | Open Meeting | RMRAS Annual FDA Update, Tom Warwick, Director of the FDA Denver District |
| December 7 | Open Meeting | Recent Warning Letter Trends |
History - 2009 Events
January 28, Computer System Validation in an FDA Environment
February 18 to April 22, 2009: RAC Study Group
March 11, Bonfils Blood Center, Company Overview and Tour
April 22 meeting, Kurt Ammon, Operations Manager for the Rocky Mountain Poison and Drug Center, Adverse Event and Product Quality Complaint Contact Centers.
May 13, 2009, An Insider's View of the EU Medical Device Regulations.
June 25, 26, Webcast of live RAPS workshop.
July 30, Advanced Topics in Good Documentation for GXPs
August 19. Preparing for Your FDA Inspection
August 25 to November 3, RAC Study Groups
September 23, Panel Discussion: Personnel Training in a Regulated Environment: Challenges, Ideas and Solutions
October 14, QSR Class.
October 15, 16 Webcast, Medical Devices and IVD: A Practical Approach to the Japanese Market.
November 12 (rescheduled from October 28 due to weather), FDA Annual Update
November 17, Webcast, Quality System Audits: What You Must Do to Prove Compliance
December 2, 2009, Regulatory Changes in the European Market
December 15, 2009, Audioconference, Control of Products and Services Obtained from Suppliers.
History - 2008 Events
August 28: Webcast; CAPA Management
September 24: Risk Management Conference; PPA Event Center
October 3: QSR Class, PPA Event Center
November 12: FDA Update, Tom Warwick, FDA Denver District Director
November 19, 20: FDA Clinical Trial Requirements
December 2: Webcast, GMPs for Investigational Drug Products.
January 14, OTS Software Validation.