Process Validation Guidance Requirements, FDA, EU Annex 15, Qualification and Validation – 4 Hours Virtual Seminar
Added by compliancetrainings on 2018-05-21
Conference Dates:
Start Date: 2018-06-08Last Day: 2018-06-08
Deadline for abstracts/proposals: 2018-06-07
Conference Contact Info:
Contact Person: AlanEmail: [email protected]
Address: Online Event, Online Event, Canada
Tel: 416-915-4438/ 58
Conference Description:
This training program will illustrate how these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Attendees will learn if they exist independently of each other or do they complement each other to enhance, build and provide a product.Areas Covered in the Session :
>. How these two different concepts are integrated (Phase 1, 2,and 3 vs. Stages 1, 2, and 3)
>. Where do they merge?
>. Do they exist independently of each other?
>. Do they complement each other to enhance, build and provide a product?
>. Where are the cGMPs initiated?
>. To what extent must cGMPs be used?
>. What happens after Stage 3 extends through commercial batch manufacturing?
>. What happens to Phase 3?
>. How does Phase 3 follow along or with Stage 3?
Who Should Attend:
>. Internal Auditors
>. Regulatory Compliance Personnel
>. Validation Managers
>. QA/QC Supervisors and Managers
>. Facilities and Engineering Department Staff
>. Manufacturing Supervisors and Managers
>. Contract Manufacturers