Source: https://www.mastercontrol.com/gxp-lifeline/medical_device/
Timestamp: 2019-06-18 15:05:59
Document Index: 794366696

Matched Legal Cases: ['art 820', 'art 11', 'art 11', 'art 11', 'art 2', 'art 1', 'art 2']

Medical device regulations are also summarized, discussed or analyzed in many of the Lifeline articles. Regulations discussed may include 21 CFR Part 820, 21 CFR Part 11, additional FDA regulations and/or international regulations. Standards that apply to the Medical Device industry may also be discussed. These standards include ISO 9000, ISO 9001, ISO 14000 and ISO 13485.
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GxP Lifeline October 2016 Issue
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GxP Lifeline December 2013 IssueFDA Inspections: Ensure Quality and Compliance
GxP Lifeline November 2013 IssueAn Argument for Quality Management Systems
GxP Lifeline October 2013 IssueTen Points for Successful Use of TPLC Reports
GxP Lifeline September 2013 IssueHow to Prepare Your DHF for the FDA
GxP Lifeline August 2013 IssueElements of Effective Quality Agreements
GxP Lifeline July 2013 IssueTen Points for Successfully Addressing Warning Letters
GxP Lifeline June 2013 IssueDisaster Recovery and Validation
GxP Lifeline May 2013 IssueAvoiding Remediation with a Good QMSHow Social Media Is Advancing HealthcareWays to Ensure Supplier Compliance
GxP Lifeline April 2013 IssueCreating, Staffing and Managing an Inspection War RoomHow Social Media Is Advancing Healthcare
GxP Lifeline March 2013 IssueSurviving the Hosted Compliance Audit: Front Line, Back Room and in the ShopBusiness Benefits of Archiving
GxP Lifeline February 2013 IssueIntroduction to High Risk Software Automated TestingFinding Ways to Cope with New Medical Device Tax
GxP Lifeline January 2013 IssueTransitioning from an FMEA Risk Analysis to a Total Risk Management SystemMasterControl Revs Operational Excellence Using Six SigmaQuality Professionals: How to Increase Your Job Security
GxP Lifeline December 2012 IssueDeveloping a QMS: Should You Buy or Build?An Engineer Takes on the Medical Device Regulatory Process, Part I
GxP Lifeline November 2012 IssueSix Costly Mistakes that Start-Up CEOs Should Avoid When Launching Medical Devices in EuropeFDASIA: Key Statutory Changes for Medical Device CompaniesFDA Compliance Officer: Industry, FDA Must Focus on Device Quality (Not Just Compliance)
GxP Lifeline October 2012 Issue
Why You Need to Go Beyond Risk Analysis and Apply Total Risk ManagementFive CAPA Tips that Help Ensure ComplianceQuality Audit: A Tool for Continuous Improvement and Compliance
GxP Lifeline September 2012 Issue
Single Sourcing of Critical Components: Strategies for OptimizationCorrective Action and Preventive Action: What's the Difference?Remote Audit: Out of Sight but Not Out of MindHow to Build a Strong Supply Chain Team
GxP Lifeline August 2012 Issue
Can You Use Automated Testing Tools as an FDA-Regulated Company?Contract Management: What's Compliance Got to Do with it?
GxP Lifeline July 2012 Issue
Challenges in Combination Product RegulationHow to "Sell" QualityRegulations Vary Worldwide but Risk Management is Common Denominator
GxP Lifeline June 2012 Issue
Quantifying Quality for GxP ComplianceWhen Good Teams Go WrongImplementing a New System: Training Reinforcement Critical
GxP Lifeline May 2012 Issue
Process Verification vs. Process ValidationSupplier Quality Agreements: Benefits to You and Your SupplierTrends in Q1 FDA Warning Letters
GxP Lifeline April 2012 Issue
Surviving the Back Room During an FDA InspectionHow Life Science Companies Can Leverage Mobile TechnologyEmploying Audits for Improved Supplier Performance
GxP Lifeline March 2012 Issue
eMDR Conversion and Implementation - Part IISupplier Quality Agreements: Benefits to You and Your SupplierEffective Nonconformance Management: Key to FDA and ISO Compliance
GxP Lifeline February 2012 Issue
eMDR Conversion and Implementation - Part IFDA Says Part 11 Guidance Remains Status QuoThe Odd Couple: Quality vs. Research (R&D)
GxP Lifeline January 2012 Issue
What to Expect When They're Inspecting - Part IIAnnex 11: The EU's New Expectations for Regulated Computerized SystemsMasterControl Presents 'Change Control--a Risk-Based Approach' at MD&M Texas
GxP Lifeline December 2011 Issue
Reading the FDA Tea LeavesEnd-to-End Supply Chain Visibility: It's no VUCA-tion for Supply Chain Professionals
GxP Lifeline November 2011 Issue
Annex 11 and 21 CFR Part 11: Comparisons for International ComplianceChange Control - Continuous Quality Improvement in FDA and ISO Environments
GxP Lifeline October 2011 Issue
What to Expect When They're Inspecting - Part IGood Clinical Practice: From Review to Application
GxP Lifeline September 2011 Issue
GxP Lifeline August 2011 Issue
Writing and Enforcing Your SOPs for GxP Compliance Success - Part 2Is There a Legal Requirement to Have SOPs for GCP in Europe?
GxP Lifeline July 2011 Issue
Writing and Enforcing Your SOPs for GxP Compliance Success - Part 1Certification and Advanced Degrees: Are They Worth It?
GxP Lifeline June 2011 Issue
How to Build a Business Case for a Quality Management SystemProduct Risk Management Under ISO 14971:2007 and ICH Q9
GxP Lifeline May 2011 Issue
The Use of "Poka Yoke" with Medical Device Design and ManufacturingManagement Review: Measuring the "Heartbeat" of Your Quality Management System
GxP Lifeline April 2011 Issue
Developing a Supplier Scorecard: Devising Aspects of Supplier PerformanceQuality Inspiration: Six Quality Quotes for You to Consider
GxP Lifeline March 2011 Issue
Product Risk Management Under ISO 14971:2007 and ICH Q9FDA Announces 510(k) Changes
GxP Lifeline February 2011 Issue
Seven Signs that Your Quality Program is in TroubleWhy Baldrige Works
GxP Lifeline January 2011 Issue
Supply Chain Oversight is the FDA's Next Area of ConcernFour Common Quality Misconceptions
GxP Lifeline December 2010 Issue
Proposed Changes to the 510(k) Process: 10 Recommendations for Strengthening the 510(k) ProgramMed-tech Firms Face a Changing Economic, Regulatory Landscape
GxP Lifeline November 2010 Issue
Assessing the Proposed Changes to the US FDA's 510(k)Conducting a Clinical Trial in Europe from the Perspective of a U.S. Virtual Company
GxP Lifeline October 2010 Issue
19 Key Elements to Review for Effective AuditsQuality Basics Simplify Complex Engineering Document Management Challenge
GxP Lifeline September 2010 Issue
Transforming Training into Learning: The Importance of a Comprehensive GxP Learning Program - Part 2ISO 9001: Quality Objectives and Quality Dreams
GxP Lifeline August 2010 Issue
GxP Lifeline July 2010 Issue
Failure Investigation: Treating the Root Cause, Not Symptoms The Medical Device Design History File, Technical File / Design
GxP Lifeline June 2010 Issue
Validation of Off-the-Shelf Software Process Validation for Medical Devices
GxP Lifeline May 2010 Issue
Tips for Avoiding Internal and External Supplier Problems Computer System Validation: FDA Inspections
GxP Lifeline April 2010 Issue
Stay Ahead of the FDA: Process Mapping, Gap Analysis and SOP Review Improving Data and Content Migration Testing: A Top Ten
GxP Lifeline March 2010 Issue
Ten Signs Your CEO Still Has No Idea About ISO 9011 and Lean The Future is Now for Computer-Based Quality Systems
GxP Lifeline February 2010 Issue
Uncertain Times for Medical Devices - Regulatory and Clinical Advice Automating Document Control Processes to Comply with FDA and ISO Requirements
GxP Lifeline January 2010 Issue
Overview of ISO 13485 - Medical Device Quality Management System Requirements Data and Content Migrations: Minimizing the Risk
GxP Lifeline December 2009 Issue
The 5 "W"s of Quality Agreements Beyond the Basics - Building Business Value through an Effective Compliance Program
GxP Lifeline November 2009 Issue
GxP Lifeline October 2009 Issue
GxP Lifeline September 2009 Issue
Writing and Maintaining SOPs: Drudgery or Delight
GxP Lifeline August 2009 Issue
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GxP Lifeline January 2009 Issue
As corporate corruption, with or without executive intent, increasingly comes to light within the life science sector the FDA is reciprocally given additional power to administrate punitive measures.Take for example the punitive measures doled out to the Purdue Frederick Company: $634.5 million after the defendants pleaded guilty to the intentional misbranding and the illegal promotion of the company's OxyContin drug.
GxP Lifeline December 2008 Issue
GxP Lifeline November 2008 Issue
GxP Lifeline October 2008 Issue
GxP Lifeline September 2008 Issue
GxP Lifeline August 2008 Issue
The recently published report, The Cost of Quality: a Study on Life Sciences, is a benchmark study by the AberdeenGroup. The report compares the quality standards and tactics of life science companies from the pharmaceutical, biotechnology, blood/biologics and medical device industries with those of Best-in-Class manufacturers.
GxP Lifeline July 2008 Issue
Poor records – and poor management of good records – can trigger needless costs, penalties, and public embarrassment for FDA-regulated companies. And if managing your own records isn’t challenging enough, FDA holds you equally responsible for ensuring the quality of records generated by your suppliers, contractors, and vendors. To protect the integrity of your regulated products and your company’s reputation, you must be proactive and continuously monitor the activities and records of each link along your supply chain, including suppliers and vendors whose activities may affect the safety and efficacy of your final product. Even if FDA does not directly regulate all of your suppliers, it’s ultimately your responsibility to ensure their records accurately reflect what’s happening at their sites.
GxP Lifeline June 2008 Issue
GxP Lifeline May 2008 Issue
GxP Lifeline April 2008 Issue
GxP Lifeline March 2008 Issue
For companies doing business in regulated environments, the benefits of implementing software systems are abundant. Improved product safety, higher quality, enhanced efficiency, and increased probability of maintaining regulatory compliance are just a sample of the numerous benefits computerized systems can provide. Why, then, do so many companies resist implementing software systems?
GxP Lifeline February 2008 Issue
GxP Lifeline January 2008 Issue
QA and IT departments are by nature two very distinct animals. Who wouldhave thought however that disconnects between the two departmentscurrently cost pharmaceutical companies millions of dollars?
GxP Lifeline December 2007 Issue
GxP Lifeline November 2007 Issue
GxP Lifeline October 2007 Issue
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GxP Lifeline August 2007 Issue
GxP Lifeline July 2007 Issue
GxP Lifeline June 2007 Issue
How does process mapping help medical device and pharmaceutical companies turn inputs into predictable outputs that would help them comply with regulations, as well as realize commercial success? There is not a magical formula for successful process mapping, but here are some “do's and “don'ts.”
GxP Lifeline May 2007 Issue
Consumer complaints are at the heart of every product recall. Whether it’s Merck’s voluntary recall of the pain medication, Vioxx, or the Class I recall of counterfeit LifeScan blood glucose test strips, chances are both actions stemmed from complaints. The following are some of the most common complaint-handling issues faced by FDA-regulated companies and practical tips on solving them.
GxP Lifeline April 2007 Issue
Why is training important to life science companies? The FDA states it clearly: “Quality is the responsibility of every employee — any employee can generate a quality problem through ignorance of their job requirements or negligence.”
GxP Lifeline March 2007 Issue
GxP Lifeline February 2007 Issue
GxP Lifeline January 2007 Issue