Navigation Links
FDAnews New Workshop, 2 Weeks to Register — Innovative Process Validation Strategies for Medical Devices, Aug. 26-27, 2014, Bethesda, MD
Date:8/14/2014

Falls Church, VA (PRWEB) August 14, 2014

Innovative Process Validation Strategies for Medical Devices:
Proving Your Processes and Documentation to the FDA
**Presented by Ombu Enterprises and FDAnews**
Aug. 26-27, 2014 – Bethesda, MD
http://www.fdanews.com/ProcessValidationConference

The quality plan has been reviewed and it’s time to focus on production processes. However, the review raises a question about which processes need process validation. But not to worry, because there is the new FDA guidance document.

The plan is to download, read it, and follow its advice. The CDRH search engine shows there is no device guidance document!

The “FDA guidance document” is for pharmaceuticals, biologics, and veterinary medicine. FDA does not have a guidance document for devices.

A colleague suggests brushing up on statistics, because process validation includes statistical techniques. The GHTF guidance document is an option, but it looks complex.

It is necessary to understand the issues from the regulatory requirements to the applications that would help build the system.

Hands-on training is needed. Introducing, Innovative Process Validation Strategies for Medical Devices Workshop — Proving Your Processes and Documentation to the FDA. This interactive workshop presented by Ombu Enterprises and FDAnews is being held Aug. 26-27, 2014 at the Marriott Bethesda North Hotel and Conference Center in Bethesda, MD.

Attendees will learn:

  • The concepts of process validation including a distinction between product verification and process validation
  • The require
    '/>"/>

Source: PRWeb
Copyright©2014 Vocus, Inc.
All rights reserved

Page: 1 2 3

Related medicine news :

1. FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC
2. FDAnews Announces — New Job Board Now Available on FDAnews.com
3. FDAnews Announces — Choosing the Right Drug Name: How to Increase Your Chances for Approval Webinar, July 22, 2014
4. FDAnews Announces — Improving Your FDA Import Success Rate: Tips for Thinking Ahead of the FDAWebinar, Aug. 7, 2014
5. FDAnews Announces Device Software Verification and Validation: Get Ready for a New Breed of Investigators, On-Demand Webinar, Aug. 12, 2014
6. FDAnews Announces CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman, Webinar, Feb. 5, 2014
7. FDAnews Management Report: Implementing Risk-Based Verification and Validation
8. FDAnews Management Report: Managing Contract Manufacturers and Testing Labs
9. FDAnews Announces The FDA Unique Device Identification (UDI) Rule Virtual Conference
10. Big Belli an Industry Leading Film Resource For Expecting Families Announces 40 WEEKS Project to Premiere in November
11. Being born 4-6 weeks premature can affect brain structure, function
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/3/2015)... , ... August 03, 2015 , ... ... agreement to Seattle-based Genelex to offer pharmacogenetic lab testing and precision medicine solutions ... health care costs. , Annually, more than 8.6 million adverse drug events ...
(Date:8/3/2015)... FL (PRWEB) , ... August ... ... most-visited bodybuilding and fitness site and the largest online retailer of nutritional ... Awards. BPI Sports is up for 11 awards in the following categories:, ...
(Date:8/3/2015)... ... August 03, 2015 , ... Novatus, Inc. ... lifecycle management solution, as well as announced the date of its next major ... ease of contract management tasks as well as enhancements to the customer experience. ...
(Date:8/3/2015)... ... ... AxoGen, Inc. (NASDAQ: AXGN), a leader in developing and marketing innovative surgical ... on Wednesday, August 12, 2015 at 9:45am (ET) at Le Parker Meridien in New ... may be accessed via the investor relations section of the Company’s website. , About ...
(Date:8/3/2015)... ... August 03, 2015 , ... The U.S. Food and Drug Administration ... is similar to deoxycholic acid, which occurs naturally in the body and helps absorb ... treat this area of the body. These are invasive procedures and very expensive for ...
Breaking Medicine News(10 mins):Health News:Novation Awards Genelex First Group Purchasing Agreement for Pharmacogenetic Testing and Precision Medicine Software 2Health News:Novation Awards Genelex First Group Purchasing Agreement for Pharmacogenetic Testing and Precision Medicine Software 3Health News:BPI Sports is Nominated for 11 Different 2015 Bodybuilding.com Supplement Awards 2Health News:BPI Sports is Nominated for 11 Different 2015 Bodybuilding.com Supplement Awards 3Health News:Novatus Unveils Milestone Software Release 2Health News:AxoGen, Inc. to Present at the Wedbush Healthcare Conference 2Health News:Dr. Ava Shamban to Offer the New Double Chin Treatment Kybella 2Health News:Dr. Ava Shamban to Offer the New Double Chin Treatment Kybella 3
... Exposure to environmental levels of the industrial chemical bisphenol A, ... long-lasting harm to testicular function, according to a new study ... The Endocrine Society,s 92nd Annual Meeting in San Diego. ... after exposure to BPA levels that are lower than what ...
... revelation that the chair of the board of Canada,s ... until April 2010 sends an unfortunate message to the ... states an editorial http://www.cmaj.ca/cgi/doi/10.1503/cmaj.100850 in CMAJ ( ... no place for the tobacco industry on the development ...
... , ... rank search results higher when there is promoter activity behind the website. , ... (PRWEB) June 21, 2010 -- The Active ... called Active Search Results Page Ranking Technology (ASR Ranking). , , ,ASR Ranking allows ...
... fish that used to be feminized after chemicals, such as ... Treatment Plant and into Boulder Creek, are taking longer to ... process, according to a new study. The results will be ... San Diego. Although the levels of the chemicals that ...
... ... performance for the year ending March 31, 2010 in spite of the economic turmoil’s impact ... the second half of 2010 compared with the same period last year. , ... Auckland, New Zealand (Vocus) June 21, 2010 ...
... The ... 33 times greater than that reported for our accredited ambulatory surgery centers. , ... (PRWEB) June 18, 2010 ... Michael Jhung et al (JAMA 2010;303(22):2273 - 2279) correctly places emphasis on the importance ...
Cached Medicine News:Health News:Early-life exposure to BPA may affect testis function in adulthood 2Health News:CMAJ calls for resignation of IDRC chair Barbara McDougall 2Health News:Active Search Results Announces its New Search Engine Ranking Algorithm 2Health News:Active Search Results Announces its New Search Engine Ranking Algorithm 3Health News:Chemicals remaining after wastewater treatment change the gender of fish 2Health News:Health IT Adoption Rates Drive Orion Health Continued Global Growth 2Health News:Health IT Adoption Rates Drive Orion Health Continued Global Growth 3Health News:Health IT Adoption Rates Drive Orion Health Continued Global Growth 4Health News:Health IT Adoption Rates Drive Orion Health Continued Global Growth 5Health News:Infection Rate in Accredited Ambulatory Facilities is Lower than in Hospitals 2
(Date:8/3/2015)... YORK , Aug. 3, 2015   ... global pharmaceutical company Allergan plc is ... Deloitte and Intermountain Healthcare to include ... harness ConvergeHEALTH,s OutcomesMiner analytics platform to generate real-world ... outcomes. "We look forward to expanding ...
(Date:8/3/2015)... Aug. 3, 2015  Dr. Cal Robinson ... & Spine Center today, providing patients with ... chronic pain through psychological counseling and treatment programs. ... Fellowship-trained, certified medical psychologist with an extensive career ... experience ranges from assessment and treatment of behavioral ...
(Date:8/3/2015)... , Aug. 3, 2015  BioElectronics Corporation (OTC ... pain management, announced that Andrew J. Whelan , ... on his program "On Business" at 9am EDT on ... interview live, tune to: http://tunein.com/radio/Money-Matters-Boston-1120-s27548/ ... on the exceptional acceptance the company,s flagship product, ActiPatch ...
Breaking Medicine Technology:ConvergeHEALTH by Deloitte and Intermountain Healthcare Expand Real World Evidence Collaboration with Allergan to Focus on Women's Health 2ConvergeHEALTH by Deloitte and Intermountain Healthcare Expand Real World Evidence Collaboration with Allergan to Focus on Women's Health 3ConvergeHEALTH by Deloitte and Intermountain Healthcare Expand Real World Evidence Collaboration with Allergan to Focus on Women's Health 4Orthopaedic & Spine Center Introduces New Pain Psychologist 2UpTick News Wire Radio Show Will Interview BioElectronics' CEO Andrew Whelan 2
... GSK ) confirmed today that a joint advisory committee to ... remain on the market. Committee members voted for recommendations ranging from making ... warnings and restrictions (20) to withdrawal from the U.S. market (12).   ... "Following today,s recommendations, ...
... July 14 D3 Radiation Services announced today  that the ... reduce errors in the delivery of radiation therapy--as a Practice Quality Improvement ... , , ... radiation oncology physicists can order a comprehensive audit of their beam data ...
Cached Medicine Technology:GlaxoSmithKline Statement in Response to FDA Advisory Committees' Vote on Safety of Avandia® (rosiglitazone) 2GlaxoSmithKline Statement in Response to FDA Advisory Committees' Vote on Safety of Avandia® (rosiglitazone) 3GlaxoSmithKline Statement in Response to FDA Advisory Committees' Vote on Safety of Avandia® (rosiglitazone) 4eDataAudit Receives Approval from the American Board of Radiology 2
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: