Controlling Change to meet GMP Requirements
Date: 2010-11-02 - 2010-11-02
Time: 10:00 - 11:30
Event Type: Conference
Event Organizer: ComplianceOnline
Contact Person: admin Send Enquiry
Country: United States USA
Region/Province/State: California
Venue: Online Event
URL: http://bit.ly/b1yPyH
Language: English
Target Participant(s): Senior management,Regulatory affairs,Quality Assurance / QAE,Production,Engineering, R&D, and software development and testing teams
Industry Sector(s): Education, Training & Employment
Manufacturing
Medical, Pharmaceutical & Herbal
Descriptions:
This change control webinar will discuss the change control activities and documentation required to meet GMP requirements.

Areas Covered in the Seminar:

- Defining a "change" and "change control".
- Tougher FDA Expectations / Requirements.
- Areas impacted.
- FDA "Hot Buttons".
- Design Control.
- Document Control; Archiving.
- Identifying "changes".
- Preventing negative changes and entropy.
- Maintain a ‘state of control’.
No. of Visits: 262
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