Understanding USP 1058 Classification for Equipment Systems in the Pharmaceutical Industry WebinarTime: 10:00 AM PST, 01:00 PM EST
Duration: 90 Minutes
Instructor: Gaurav Walia
This webinar will focus on Proper USP General Chapter: 1058 (Analytical Instrument Qualification) Classification for Equipment in the Pharmaceutical Industry. Proper Interpretation and Understanding can be quite difficult in today´s Compliance and Regulatory Landscape with so many changes to the Regulatory Environment and current Enforcement Trends. Overall, this webinar will provide the attendees with the Ultimate set of Tools in order to help their firms during a Regulatory Inspections and in setting up a Proper Equipment Qualification System Validation Program in their Respective Laboratory Settings with USP General Chapter 1058 Classification in mind.
Why Should you Attend
This webinar will focus on the latest trends and interpretation from recent FDA and international regulatory inspections when in specifically comes to Laboratory Equipment and Software Systems. Additionally, this webinar will focus on USP General Chapter 1058 while looking also looking at a Risk Based Approach.
This webinar will also focus on Group A, B and C General Classification of Laboratory Systems. The roots of how this General Chapter evolved from the grass roots movements of once thought of becoming a Food and Drug Administration (FDA) Regulatory Guidance. Concurrently, this webinar will briefly discuss, compare and contrast GAMP5 Classification. Key Laboratory Equipment and Software Technologies that being currently utilized will also be discussed such as HPLC, GC, Mass Spectrometers, Balances, UV/VIS, KF, UPLC, etc.
Objectives of the Presentation:
- Learning about Equipment Qualification
- Discussing key USP General Chapter 1058 on Analytical Instrument Qualification (AIQ)
- Learning about the history of GAMP classification
- Learning about GAMP 5
- Focus on key Software Systems Validation
- Highlights of key regulatory and inspectional trends when it comes to these systems
- Key Quality system examples highlighted in many regulatory inspections
- Computer Systems Validation focus
- 21CFR Part 11
- ERES (Electronic Records and Electronic Signatures)
Current Domestic Food and Drug Administration regulatory trends
Current GAMP 5/USP trends when it comes to Equipment Software Systems