Pack of Four: Best selling Lab related webinars
Instructor:
Dr. Ludwig Huber
Product ID: 700960
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.
More Training By Experts
- Understanding and Implementing USP <1058>: Analytical Instrument Qualification
- Change Control for Computer Systems - strategies and tools for FDA compliance
- Master Planning for Computer System Validation
- Managing Failure Investigations and OOS Situations - Regulatory Requirements and Strategies for Implementation
- Effective Training for FDA Compliance: What to train - How much to Train - How to Document Effectiveness
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
