Calibration and Qualification in Analytical Laboratories
Instructor:
Dr. Ludwig Huber
Product ID: 701548
- Duration: 75 Min
Why Should You Attend:
Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify, test and document.
This Online training will discuss all details and give strategies and case studies for easy implementation.
Complimentary Hand-Outs:
For easy implementation, attendees will receive:
- 4 SOPs
- User Requirement Specifications (URS) for analytical equipment
- Change control for analytical equipment
- Qualification of equipment
- Allocating Analytical Instruments to USP <1058> Categories
Areas Covered in the Webinar:
- Operational lab equipment requirements for calibration and qualification
- Most common inspection problems
- USP Chapter <1058>: Analytical Instrument Qualification
- Development of an effective equipment qualification master plan
- Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification
- Allocating equipment to qualification categories A, B and C
- Qualification and documentation requirements for each category
- Going through the category example list
- Approach for existing systems
- Approach for automated systems (incl. firmware/computer systems)
- Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
- Documentation requirements
Who Will Benefit:
- QA managers and personnel
- Analysts and lab managers
- Analysts
- QA managers and personnel
- Quality Unit manager and personnel
- Regulatory affairs
- Training departments
- Documentation department
- Consultants
Dr. Ludwig Huber
Director and Chief Editor, Labcompliance
Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. Dr. Huber is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.
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).
