Navigation Links
Former FDA Inspectors Train Medical Device, Pharmaceutical Companies How to Prepare for FDA Inspections of Their Quality Systems
Date:8/16/2012

WASHINGTON, Aug. 16, 2012 /PRNewswire/ -- EduQuest has trained hundreds of FDA inspectors; now it's training thousands of those preparing for inspections.

A global team of FDA inspection experts, EduQuest is presenting a series of training courses for quality managers and regulatory specialists September 24-28, 2012, at the Hilton Garden Inn in Frederick, Maryland (near Baltimore and Washington, DC, just off Interstates 70 and 270).

Course topics include:

- FDA Auditing of Computerized Systems and Part 11/Annex 11, including a mock FDA inspection (3 days)

- Quality Risk Management for FDA/ICHQ9 Compliance (1/2-day)

- The CAPA Confidence Clinic: Effective Corrective and Preventive Action (CAPA) Systems, Failure Investigations, and Complaint Management (1 1/2-days)

Each course is taught by instructors with personal experience conducting FDA inspections and being quality system expert advisors for industry. As a result, attendees receive practical guidance from those who understand the expectations of FDA inspectors plus the resource realities faced by regulated industry.

Over the past 15 years, EduQuest has trained FDA's Office of Regulatory Affairs (ORA), the lead office for all of FDA's field activities (including inspections and recalls) and Health Canada inspectors.

The lead instructor is Martin Browning, president of EduQuest and the former vice chair of the FDA Electronic Record and Signature Work Group, where he helped to write the original Part 11 rules for quality data security and integrity.

Students can attend the entire week of training classes or select individual courses. T
'/>"/>

SOURCE EduQuest
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Dr. Michael Yaremchuk, Leading Performer of Custom-Designed Facial Implants, Pioneers Bespoke Plastic Surgery
2. PharmaVentures Helps Secure Investor for Former MSD Research Site
3. PAREXEL Appoints Former Senior FDA Official David Elder to Global Team of Strategic Compliance Experts
4. Former Sanofi-aventis and US Oncology Executive Joins New Century Health as Chief Executive Officer
5. Fox Insurance Company Awarded $3.3 Million in Arbitration Against Former Pharmacy Benefit Manager
6. NPL named by Semta as a top training provider
7. Infectious Disease Prevalence and New Strains Appearing Each Year Makes a Watertight Case for Clinical Laboratory Testing, Finds Frost & Sullivan
8. Online Training for Hospital Value Based Purchasing Now Available
9. Researchers tune the strain in graphene drumheads to create quantum dots
10. Nano-infused paint can detect strain
11. The Spring 2012 MediSend Biomedical Repair Training Program™ Sends Graduating Biomedical Technicians to Hospitals Around the World
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2015)... ... August 27, 2015 , ... The Kansas City Animal Health ... animal health companies to hear from animal health companies with the newest technology. ... licensing agreements or distribution contracts. This meeting is one of the only ...
(Date:8/27/2015)... - Portage Biotech Inc. ("Portage") (OTC Market: PTGEF, ... Company Limited (Biohaven), announced today that dosing has ... a glutamate modulating agent. Biohaven filed an investigational ... clearance from the U.S. Food and Drug Administration ... 54% equity interest in Biohaven, a private company. ...
(Date:8/27/2015)... , Aug. 27, 2015 /PRNewswire/ - BIOREM Inc. (TSXV: BRM) ("Biorem" ... six-month periods ended June 30, 2015. Biorem,s complete second quarter financial ... FINANCIAL HIGHLIGHTS: in ,000,s except earnings per shareThree-months ended , ... 2014 , 2015 , 2014 Revenue , ... , 4,433 Gross profit , 1,656 , ...
(Date:8/27/2015)... ... 27, 2015 , ... Inc. Magazine released its annual list of the 5,000 ... in growth for the three years through 2014. Being named to the Inc. 5000 ... in the country. , “We are thrilled to make the Inc. 5000 list ...
Breaking Biology Technology:VetStem Biopharma, Inc. Among Seventeen Companies Selected to Present at the KC Animal Health Investment Forum on September 1st 2015 2VetStem Biopharma, Inc. Among Seventeen Companies Selected to Present at the KC Animal Health Investment Forum on September 1st 2015 3Portage's Biohaven doses first human subject in Phase 1 trial with lead drug candidate BHV-0223 2Portage's Biohaven doses first human subject in Phase 1 trial with lead drug candidate BHV-0223 3Portage's Biohaven doses first human subject in Phase 1 trial with lead drug candidate BHV-0223 4BIOREM Reports $718,000 Net Earnings for the Second Quarter 2BIOREM Reports $718,000 Net Earnings for the Second Quarter 3iLab Solutions Named to 2015 Inc. 5000 List 2iLab Solutions Named to 2015 Inc. 5000 List 3
... Fibrillation, EP Mapping and ... PCI and Additional Complex Procedures, ST. LOUIS, ... announced today that more than 10,000 procedures have ... utilizes,advanced, magnet-guided navigational technology intended to help,electrophysiologists and ...
... is showcasing its,motion management systems at this year,s ... 8-13, 2007, at the Palau de,Congresos de Catalunya ... motion management and patient positioning at the,Elekta booth ... "Holding still for 10 minutes? Bet you ...
... SGX Pharmaceuticals, Inc.,(Nasdaq: SGXP ) today provided ... Novartis focused on the development and commercialization of,BCR-ABL ... and drug resistant,Chronic Myelogenous Leukemia (CML). Under ... number of,potential drug candidates, with the anticipated timeline ...
Cached Biology Technology:Stereotaxis' Niobe System Used to Perform More Than 10,000 Procedures Worldwide 2Stereotaxis' Niobe System Used to Perform More Than 10,000 Procedures Worldwide 3Elekta Brings Intelligent Ways to Manage Motion During Cancer Treatment to ESTRO 2SGX Provides Update on BCR-ABL Collaboration 2SGX Provides Update on BCR-ABL Collaboration 3
(Date:8/4/2015)... 04, 2015 ... announced the addition of the "Digital ... Service), Sub-Segment (Computer Forensics, Network Forensics, Mobile ... Service, Vertical and Region - Global Forecast ... By Component (Hardware, Software, and ...
(Date:7/31/2015)... -- Den 10. internationale konference om Genomik (ICG-10, ... 25. oktober i Shenzhen , Kina. ... år. Siden starten i 2006 er ICB blevet en ... er en af de mest dynamiske, entusiastiske og sjove ... gennembrud og fremskridt inden for ,omik,-forskning, som yderligere vil ...
(Date:7/31/2015)... , Chine, 31 juillet 2015 La ... www.icg-10.org ) sera organisée par le BGI du ... Shenzhen en Chine. La ... son inauguration en 2006, l,ICG est devenue l,une ... le domaine des « omiques » et c,est aussi la ...
Breaking Biology News(10 mins):Digital Forensics Market - The Market Represents a Compound Annual Growth Rate (CAGR) of 11.3% From 2015 to 2020 2Den 10. internationale konference om Genomics (ICG-10) åbner i oktober 2La 10e International Conference on Genomics (ICG-10) doit s'ouvrir en octobre 2La 10e International Conference on Genomics (ICG-10) doit s'ouvrir en octobre 3
... The December 2009 issue of the Journal ... Christopher Ahern (The University of British Columbia, Vancouver) and ... other K+ channels using in vivo nonsense suppression technology. ... www.jgp.org ). According to Riccardo Olcese (UCLA) in ...
... of New Hampshire assistant professors have received prestigious ... (CAREER) grants. Vaughn Cooper of the department of ... to better understand beneficial mutations in bacteria by ... White of the mechanical engineering department received $400,000 ...
... general rule among mammals that larger males sire more ... Coltman has found a genetic quirk that might make ... Big, heavy males mountain goats shove lightweight Romeos ... males pass their physical attributes and mating success to ...
Cached Biology News:2 UNH faculty receive $1.4M in CAREER grants from NSF 2
MOUSE ANTI RAT RT1Bu Immunogen: Rat thymocyte membrane glycoproteins...
RABBIT ANTI HUMAN CYTOCHROME P450 1A1/2 Immunogen: Purified human CYP1A2 expressed in E.Coli ...
RABBIT ANTI HUMAN APP (KP1 DOMAIN) Immunogen: Synthetic peptide composed of amino acids 292-312 from the KPI domain of human APP....
... Diagnostics Cytomegalovirus (CMV) pp65 Antigenemia Immunofluorescence Assay ... of lower matrix protein pp65 of CMV ... Components: Erythrocyte Lysis ... containing 220 mL of buffered ammonium chloride. ...
Biology Products: