ComplianceOnline

Pack of Four: Best selling Lab related webinars

Instructor: Dr. Ludwig Huber
Product ID: 700960

Training CD

$1,000.00
$2,000.00 (50%)
Save $1,000.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

Clinical Labs are a tough environment to be in. Not only are there a multitude of rules, there are a number of areas which are not very clearly defined. On top of all this, the rules keep changing all the time.

Description

ComplianceOnline brings you a special clinical training primer. A package of 4 of our best selling Lab related webinars- available at a 50% discount.

Clinical Labs are a tough environment to be in. Not only are there a multitude of rules, there are a number of areas which are not very clearly defined. On top of all this, the rules keep changing all the time.This pack of 4 of our best selling lab related webinars contains 5 hours of training covering some of the most important compliance challenges being faced by Clinical and Analytical Labs today.

Module1:Good Laboratory Practice Regulations

Area Covered:

  • FDA and International GLP regulations: 21 CFR Part 58.
  • Objectives and concepts of GLP’s.
  • Special organizational requirements.
  • Responsibilities: Management, Study director, QA, analysts.

Module2:Analytical Instrument Qualification-Understanding the New USP draft Chapter

Area Covered:

  • FDA and EU requirements for analytical instrument qualification.
  • Most common inspection problems.
  • Terminology, scope and principles of the new USP chapter.
  • AIQ and its relation to method validation, system suitability testing and quality control checks.

Module3:Validation and Use of Excel Spreadsheets in FDA Regulated Environments

Area Covered:

  • FDA and other agency?s requirements for spreadsheet validation - what do inspectors ask and what documents should be available.
  • How to design spreadsheets for Part 11/GxP/SOX/HIPAA compliance.
  • Validation during design, development, installation and on-going use.
  • When, what, and how much to test?

Module4:Transfer of Analytical Methods and Procedures:FDA Requirements and Strategies and Tools for Implementation

Area Covered:

  • FDA and International regulations for method transfer.
  • Examples of FDA warning letters and how to avoid them.
  • The new FDA Guidance on method transfer.

Instructor Profile:
Ludwig Huber, Ph.D., is Compliance Program Manager at Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books "Computer System Validation", "Network Quality Package" , and "Validation of Computerized Analytical and Networked Systems". For more information, visit Dr. Huber’s website: www.ludwig-huber.com.

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