FDAnews Announces — How to Implement USP 1058 for Lab Equipment Qualification: Creating a Bullet-Proof Master Plan Webinar, Aug. 21, 2014

The large number of FDA warning letters continually issued for improper equipment qualification is a clear sign that companies are still struggling to correctly implement this USP 1058 general chapter. During this webinar, Dr. Ludwig Huber, PhD will take attendees step-by-step through the complete qualification process and teach them how to create a bullet-proof master plan that will pass FDA scrutiny.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) July 31, 2014

How to Implement USP 1058 for Lab Equipment Qualification
Creating a Bullet-Proof Master Plan
**FDAnews Webinar**
Aug. 21, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/USP1058LabEquipmentQualification

Worldwide, USP general chapter 1058 is considered the gold standard for analytical instrument qualification and calibration.

But the large number of FDA warning letters continually issued for improper equipment qualification is a clear sign that companies are still struggling to correctly implement this requirement.

Some say it's because 1058 doesn't really give specific 'how to' advice on qualifying laboratory instruments. Regardless of the reason, though, manufacturers are desperately looking for answers to their questions. There's a real need for help.

That's why FDAnews and Dr. Ludwig Huber, PhD, are joining together on Aug. 21, 2014 to present the 90-minute webinar How to Implement USP 1058 for Lab Equipment Qualification.

During this webinar, Dr. Huber will take attendees step-by-step through the complete qualification process and teach the, how to create a bullet-proof master plan that will pass FDA scrutiny.

He'll focus on the all-important planning process and show how to write a practice qualification report. In addition, attendees will hear Dr. Huber's practical recommendations and receive such valuable tools as qualification examples, test scripts and templates.

Attendees will also learn the 3 industry-proven SOPs that take the guesswork out of how you interpret and implement USP 1058:

1.    Allocate lab equipment into 3 USP categories
2.    Define required procedures and deliverables for each category
3.    Qualify equipment according to the USP chapter

BONUS: Registered attendees, will also get their own downloadable copy of Dr. Huber's 70-page primer “Analytical Instrument Qualification and System Validation," the best reference resource on this topic that you'll find anywhere.

Meet the Presenter:
Ludwig Huber, Ph.D., is the director of Labcompliance and editor of the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems."

More than 20 years ago, Dr. Huber published the 4Q approach for analytical instrument qualification that has been taken for USP 1058. Since then he has given numerous presentations on GLP/GMP, 21 CFR Part 11 and Validation around the world, including seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, IVT, PDA, PIC/S and other national health care agencies.

Who Will Benefit:

  •     Auditors
  •     Compliance officers
  •     Consultants/service providers
  •     Managers
  •     Manufacturing directors and supervisors
  •     Personnel new to the industry
  •     Pharmaceutical and cGMP auditors
  •     QA/QC personnel
  •     R&D staff
  •     Regulatory/legislative affairs professionals
  •     Training personnel
  •     Validation specialists, scientists, engineers

Webinar Details:
How to Implement USP 1058 for Lab Equipment Qualification
Creating a Bullet-Proof Master Plan
**FDAnews Webinar**
Aug. 21, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/USP1058LabEquipmentQualification

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/USP1058LabEquipmentQualification
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.