Process Validation - Statistical Process Control - 2017

Overview:
Process knowledge and understanding is the basis for establishing an

approach to process control and related instruction sets in the Batch Record

for each critical step of the process operation and the overall process results

based on statistical database for each batch of that product code.

Why should you Attend:
To gain a current comprehension of the new PV Guidelines and the

determination of how to do the required Statistical Monitoring and Data

Analysis to prove the process is consistent and to avoid situations that could

cause 483s, Warning Letters and Consent Decrees as well as gaining the

capability of avoiding rework and recall expenses.

Areas Covered in the Session:
Process knowledge and understanding is the basis for establishing an

approach to process control and related instruction sets in the Batch Record

for each unit operation and the process overall.

Who Will Benefit:
Manufacturing Operations
Formulation
Engineering
QA/QC
Product and Process Development
Regulatory Affairs

Speaker Profile:
Jerry Dalfors has extensive (40 years) of business administration,

consultative, technical and managerial experience in the development and

manufacture of highly regulated biopharmaceutical products including

injectables, biologics, medical devices and oral dosages.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
At a Glance
When 18 July 2017
Where Online
Organizer Netzealous LLC DBA - Compliance4All
Event Type conference
Official Website
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Added by Compliance4all
Added on 15 May 2017
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