JOY MCELROY


Auditing Quality Suppliers and Vendors
Auditing Quality Suppliers and Vendors
: Joy Mcelroy
: 17 January 2019
: 01 : 00 PM EST
: 90 Minutes

The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.Learning Obj.....

$179.00
Process Validation for Drugs and Biologics
Process Validation for Drugs and Biologics
: Joy Mcelroy
: 08 February 2019
: 01 : 00 PM EST
: 90 Minutes

Understand the new FDA perspective of a "Process Validation Life-Cycle" that starts at the Process Design phase (Process/Product Development) and continues through Process Qualification (Confirmation) and Continued Process Verification (Monitoring and Assessment of the process effectiveness) as stated by the FDA's new Guideline on Process Validation and its impact on how process validation activities are ca.....

$179.00
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