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FDA and Customs Monitoring of International Purchasing: What You Need to Know

by John Gagliardi | Apr 2018 (Legal, Clinical & Regulatory) ... of Compliance, FDA, will speak alongside Mr. Gagliardi during the session: Purchasing Controls: Embracing Your Process to Net Time, Money and Compliance   With that knowledge, this article ... Read more »

The Medical Device Labelling Process Needs to Start Early in Design Controls

by John Gagliardi | Feb 2018 (Legal, Clinical & Regulatory) ... can be of assistance? John Gagliardi has had success over the past 45+ years in the medical device and pharmaceutical industries because of his practical approach to process-orientation and business. ... Read more »

Medical Device Single Audit Program Attracts Growing Interest from U.S. Companies

by John Gagliardi | Dec 2017 (Legal, Clinical & Regulatory) ... by the CDRH to determine if enforcement actions must be considered.  John Gagliardi has had success over the past 45+ years in the medical device and pharmaceutical industries because of his practical approach ... Read more »

CAPA Notes from an FDA Inspection

by John Gagliardi | Oct 2017 (Legal, Clinical & Regulatory) Corrective and Preventive Actions or CAPA touches nearly every process in the Quality Management System (QMS). Read insight gained by John Gagliardi while participating in the interactions between the ... Read more »

Device Recalls: Prepare for the Unexpected to Minimize Operational and Fiscal Damage

by John Gagliardi | Jun 2017 (Legal, Clinical & Regulatory) ... t Treat Your FDA Inspection Like an ISO Audit When Do I See a CAPA Specialist? Pareto Analysis: Tools for New Product Testing   John Gagliardi has had success over the past 45+ yea ... Read more »

Don't Treat Your FDA Inspection Like an ISO Audit

by John Gagliardi | May 2017 (Legal, Clinical & Regulatory) ... quality system audit.     Chicago | June 13-15 John Gagliardi will present two sessions  on ISO 13485 at OMTEC 2017:  How to use quality data How to prepare for audits More on ISO 13485 ... Read more »

A Watchful Eye on Device Performance can Decrease Postmarket Surveillance Burdens

by John Gagliardi | Jan 2017 (Legal, Clinical & Regulatory) ... and, at the same time, reduce the burdens and costs of postmarket surveillance in a healthy continuum. John Gagliardi has had success over the past 45+ years in the medical device and pharmaceutical ... Read more »

Building Your Bridge to the Island of ISO 13485:2016

by John Gagliardi | Nov 2016 (Legal, Clinical & Regulatory) ... slammed. Therefore, it’s important to start the process now. Regular BONEZONE contributor John Gagliardi suggests that ISO 13485 implementation is like building a bridge, connecting your current quality ... Read more »

Resubmitting a 510(k) is More Than a Regulatory Decision

by John Gagliardi | Sep 2016 (Legal, Clinical & Regulatory) ... John Gagliardi has had success over the past 46 years in the medical device and pharmaceutical industries because of his hands-on approach to process-orientation and business perception. He has been act ... Read more »

Third Party Reviews – Is This the Real Deal?

by John Gagliardi | Jun 2016 (Legal, Clinical & Regulatory) ... ke a difference. John Gagliardi has had success over the past 46 years in the medical device and pharmaceutical industries because of his hands-on approach to process-orientation and business percepti ... Read more »

Supplier Quality Agreements Are Not Just a Handshake Anymore

by John Gagliardi | Apr 2016 (Legal, Clinical & Regulatory) ...  John Gagliardi has had success over the past 45 years in the medical device and pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved ... Read more »

The Revitalized ISO 13485: Ready for Business

by John Gagliardi | Feb 2016 (Legal, Clinical & Regulatory) ... device suppliers, regulators and clients.     Want more information on FDA regulations or the CAPA process? Want to hear more from John Gagliardi? Come to OMTEC 2016 and attend one, or ... Read more »

The Top Industry News from 2015

by BONEZONE | Jan 2016 (Voice of Industry) ... requirements. There are major issues that arise time and again due to companies’ lack of understanding of the role of design controls. Author John Gagliardi broke these issues down in the December issue ... Read more »

8 Design Control Issues Found During FDA Inspections

by John Gagliardi | Nov 2015 (Research & Development) ... but it sure helps. All FDA inspectors are not design engineers, but most of them can sense when a design controls process is out of control. John Gagliardi has had success over the past 45 years in the ... Read more »

Manufacturing or Selling Medical Devices in Mexico: A Regulatory Conundrum

by John Gagliardi | Oct 2015 (Business Critical) ...  Manufacturers Compete to Serve Growing Asian Population and Brazil Remains Among Top Ten Markets, Despite Economic Downturn.   John Gagliardi has had success over the past 45 years in the medical devic ... Read more »

Orchid Design Selected to Participate in FDA’s Submission Tracker Pilot Program

by BONEZONE | Aug 2015 (Supplier News Items) ...  In his 2014 BONEZONE article, FDA Seeks 21st Century Agility with 510(k)s, John Gagliardi discussed initiatives designed to clarify the 510(k) submission process. How will these affect your device's pa ... Read more »

Purchasing Controls: Draft the Best Supplier Quality Agreement

by John Gagliardi | Jul 2015 (Supply Chain Management) ... result in a warning letter from FDA. This is true even though there is no actual legal requirement to have an agreement of this nature. John Gagliardi has had success over the past 45 years in the medical ... Read more »

How to Avoid Risky CAPA Decisions

by John Gagliardi | Mar 2015 (Legal, Clinical & Regulatory) ... trends from “important corrections” could be instrumental in defining your company’s improvement initiatives. John Gagliardi has had success over the past 45 years in the medical device and pharmaceutical ... Read more »

Compliance Isn’t Accidental: A Case for Management’s Commitment to Quality

by John Gagliardi | Jan 2015 (Legal, Clinical & Regulatory) ... looked, medical device companies are part of a regulated industry that becomes more complex every day. John Gagliardi has had success over the past 45 years in the medical device and pharmaceutical industries ... Read more »

Why Won’t My CAPA Process Work?

by John Gagliardi | Dec 2014 (Legal, Clinical & Regulatory) ... the mirror and answered her own questions. John Gagliardi has had success over the past 40+ years in the medical device and pharmaceutical industries because of his practical approach to process-orientation ... Read more »

FDA Seeks 21st Century Agility with 510(k)s

by John Gagliardi | Oct 2014 (Legal, Clinical & Regulatory) ... have greater credibility and a certain consistency you can depend on. FDA believes that the new approaches to Premarket Notifications will make a difference, and so do I. John Gagliardi has had success ... Read more »

FDA Clarifies Substantial Equivalence Requirements for 510(k) Submissions

by Justin Rowland | Sep 2014 (Legal, Clinical & Regulatory) ... or through LinkedIn. Kapstone Medical www.kapstonemedical.com John Gagliardi reviews the history and future of the 510(k) process in your October print issue. Don’t miss his update on submission approaches. ... Read more »

The Starting Line: Turning the Corner with a Device Concept

by John Gagliardi | Jul 2014 (Research & Development) ... that use it, especially among marketing, engineering and manufacturing. John Gagliardi has had success over the past 40+ years in the Medical Device and Pharmaceutical industries because of his practical ... Read more »

Design Controls: A 17-Year Learning Curve

by John Gagliardi | May 2014 (Research & Development) ... effort together on a daily basis to assure that process controls actually work, and that medical devices are safe and effective for human use.  John Gagliardi has had success over the past 43 years in ... Read more »

Synergetic Dissimilarity: Design Validation/Verification and Process Validation

by John Gagliardi | Mar 2014 (Research & Development) Verification and validation are commonly confused. John Gagliardi defines the intertwined engineering tools and outlines how they are practiced. After all of these years “under the umbrella” of The ... Read more »

Postmarket Surveillance and Vigilance: Making Risk-based Decisions

by John Gagliardi | Dec 2013 (Research & Development) ... Management? Read it here: The Science of Minimizing Uncertainties John Gagliardi has had success over the past 43 years in the Medical Device and Pharmaceutical industries because of his practical approach ... Read more »

Risk Management: The Science of Minimizing Uncertainties

by John Gagliardi | Oct 2013 (Research & Development) ... contend that Product Realization is driven by risk management planning and ongoing change management. John Gagliardi has had success over the past 43 years in the Medical Device and Pharmaceutical industries ... Read more »

India Considering New Device Regulations

by John Gagliardi | Aug 2013 (Business Critical) ...  destination for clinical studies.   John Gagliardi has had success over the past 43 years in the Medical Device and Pharmaceutical industries because of his practical approach to process-orientatio ... Read more »

Spotlight on Asia

by BONEZONE | Aug 2013 (Business Critical) ... in Asia.” For more on the changing orthopaedic industries in China and India, John Gagliardi of MidWest Process Innovation continues the conversation: China Becomes Vastly Improved Player India Considering ... Read more »

China Becomes Vastly Improved Player

by John Gagliardi | Jul 2013 (Business Critical) ...  Look for more on the growing Asian market in the August issue of BONEZONE. John Gagliardi has had success over the past 43 years in the Medical Device and Pharmaceutical industries because ... Read more »

Design Control Hot Buttons to Expect During an FDA Inspection

by John Gagliardi | May 2013 (Legal, Clinical & Regulatory) ... Report and flagged for review by the Office of Device Evaluation. Legal, Clinical & Regulatory   John Gagliardi has had success over the past 40 years in the Medical Device and Pharmaceutical industries ... Read more »

Just Because You’re Trained, Doesn’t Mean You’re Competent

by John Gagliardi | Apr 2013 (Legal, Clinical & Regulatory) ...  and efficiently.   John Gagliardi has had success over the past 43 years in the medical device and pharmaceutical industries because of his practical approach to process-orientation and business ... Read more »

Passing Brazil’s Inspections to Take Product to Market

by John Gagliardi | Jan 2013 (Business Critical) ... assurance and ensure future compliance. For more on Brazil, read our Q&A with orthopaedic professionals based in the country. John Gagliardi has had success over the past 40 years in the Medical ... Read more »

The Quality Review Board: A Conduit for Success

by John Gagliardi | Dec 2012 (Research & Development) ...  John Gagliardi has had success over the past 40 years in the Medical Device and Pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively ... Read more »

Complaints: A Second Chance to "Make it Right"

by John Gagliardi | Oct 2012 (Research & Development) ... ofessional and efficient handling of complaints is a critical factor for all orthopaedic manufacturing companies, world-wide.   John Gagliardi has had success over the past 40 years in the Medical De ... Read more »

Quality by Design: Incoming Acceptance Activities of Purchased Materials

by John Gagliardi | Aug 2012 (Research & Development) ...   John Gagliardi has had success over the past 40 years in the Medical Device and Pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involv ... Read more »

The Anatomy of a Warning Letter, Part Two: Excerpts and Response Strategies

by John Gagliardi | Jun 2012 (Legal, Clinical & Regulatory) ... of life at your company and not just “lip service.” Need to know more about FDA Warning Letters? Continue learning from John at his OMTEC sessions in June. John Gagliardi has had success over the ... Read more »

The Anatomy of a Warning Letter, Part One: A Primer

by John Gagliardi | Mar 2012 (Legal, Clinical & Regulatory) ... www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm  John Gagliardi has had success over the past 40 years in the Medical Device and Pharmaceutical industries because of his practical approach ... Read more »

Planning for the Unpredictability of Change

by John Gagliardi | Dec 2011 (Research & Development) ... rides are not for faint of heart.   John Gagliardi has had success over the past 40 years in the Medical Device and Pharmaceutical industries because of his practical approach to process-orientation ... Read more »

BONEZONE Videos Main Page

by BONEZONE | Oct 2011 (BONEZONE Videos) ...  Posted: March 7, 2016   In anticipation of his OMTEC 2016 session, John Gagliardi, President of MidWest Process Innovation, shares the business sense of good design controls.   Pric ... Read more »

The Internal Quality Audit Process for Orthopaedic Medical Device Companies: Risk Indicators and Uncertainties

by John Gagliardi | Aug 2011 (Research & Development) ... ry bodies) and the demands of a dynamic business strategy. John Gagliardi has had success over the past 40 years in the Medical Device and Pharmaceutical industries because of his practical approach ... Read more »

Corrective and Preventive Action: What Does FDA Look For During Inspection?

by John Gagliardi | Mar 2011 (Research & Development) ...  assessment. John Gagliardi has had success over the past 40 years in the Medical Device and Pharmaceutical industries because of his practical approach to process-orientation and business. He has bee ... Read more »

Design Controls: Design Transfer, Changes and the Design History File

by John Gagliardi | Dec 2010 (Research & Development) ... design engineers and manufacturing engineers. Review these articles online by visiting the BONEZONE journal archives at www.orthoworld.com. John Gagliardi has had success over the past 40 years in ... Read more »

Design Controls: Design Verification and Validation

by John Gagliardi | Sep 2010 (Research & Development) ...  what they have done is sufficient to ensure that their device can be used safely and effectively. John Gagliardi has had success over the past 40 years in the Medical Device and Pharmaceutical indu ... Read more »

Design Controls: Design Review

by John Gagliardi | Jun 2010 (Research & Development) ... . John Gagliardi has had success over the past 40 years in the Medical Device and Pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involv ... Read more »

Design Controls: Inputs and Outputs in Synergy

by John Gagliardi | Mar 2010 (Research & Development) ...    OMTEC 2010 Speaker Mr. Gagliardi presented two OMTEC workshops on Wednesday and Thursday mornings, June 16 and 17. Workshop I – QSR Design Controls: Concept and Feasibility to Commercialization ... Read more »

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