FDAnews Announces — Equipment Maintenance Calibration and Cleaning: Often Overlooked, Never Forgotten Webinar, Nov. 19, 2015

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The FDA’s newest crop of inspectors — many of them recently hired from industry — are focusing on equipment maintenance, calibration and cleaning. And they know where to look for problems and what probing questions to ask during inspections.

FDAnews

FDAnews

Equipment Maintenance Calibration and Cleaning:
Often Overlooked, Never Forgotten
Nov. 19, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/equipmentmaintenancecalibrationcleaning

The FDA’s newest crop of inspectors — many of them recently hired from industry — are focusing on equipment maintenance, calibration and cleaning. And they know where to look for problems and what probing questions to ask during inspections.

Having been in the trenches, they know where manufacturers are slacking and they’re hot on the trail of basic GMP violations.

Are the equipment maintenance, calibration and cleaning programs FDA-ready?

As a regulatory requirement, preventive maintenance, calibration and cleaning programs are what help assure that the validated state of equipment utilities and systems remain in a state of control.

But for the state of control to pass FDA muster — during every production shift — manufacturers need to understand that the establishment of operational limits are impacted by the successful implementation of such programs and, if not properly maintained, will adversely impact the final quality results.

On Thursday, Nov. 19, FDAnews has invited back specialist Jerry Dalfors — an industry veteran with more than 40 years’ experience, who’s been chosen by the FDA to train their own field inspectors, and whose work has never received a 483 — to share all the details manufacturers need for an effective equipment maintenance, calibration and cleaning program plan that works.

Specifically attendees will learn:

  • What a written maintenance plan is required by law to contain
  • The specific types of things ex-industry inspectors are finding — i.e. fluid levels, worn washers and fittings, leaky pipes, etc.
  • How to combat a “fix it and forget it” mentality and how to assure the little things get monitored after plans are implemented
  • Why operational limits should be set by observation, not regulation

Meet the Presenter:
Jerry Dalfors
Principal, JD Technologies

Jerry Dalfors has 40-plus years of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.

Who Will Benefit:

  • Engineering and environmental control teams
  • Manufacturing directors and supervisors
  • GMP auditors
  • Risk management specialists
  • Training personnel
  • Validation specialists, scientists, engineers
  • QA/QC personnel
  • Compliance officers
  • Managers
  • Personnel new to the industry
  • Regulatory affairs professionals
  • Consultants/service providers
  • Executive management
  • General/corporate counsel

Webinar Details:
Equipment Maintenance Calibration and Cleaning:
Often Overlooked, Never Forgotten
Nov. 19, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/equipmentmaintenancecalibrationcleaning

Tuition:
$287 per site
Easy Ways to Register:
Online: http://www.fdanews.com/equipmentmaintenancecalibrationcleaning
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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