Seminar on Modern Approaches to Process Validation Requirements for Process Design, Design of Facilities and the Qualification of Equipment
Organization:
NetZealous - Globalcompliancepanel
Category:
OTHER
Geographical Area:
Business Event Calendar
Start
Date:
12/10/2015
End Date:
12/11/2015
Start Time:
09:00 AM
End Time:
06:00 PM
Event
Info:
Overview:
Companies face many common issues and confusion when creating or revamping their validation programs. Some of these common issues are: • Company has expertise in its process validation program but can never quite get is arms around the facility and equipment changes that require never ending equipment qualification (IQ, OQ, PQ), • Customer or 483 audit findings require the company to deviate from its own validation program to meet the needs of the FDA or the customer • For systems that employ software and hardware, how does the company manage the validation activities (i.e. through the software validation effort or through the equipment qualification program? Well, the answers to these and many, many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.
Why should you attend?
Attend this FDA validation seminar to get deep knowledge about: • How to define a Sustainable Structure of a Firm's Validation Program • Understand How Change Control and Other Quality Programs Feed Into the Validation Program • Offer Usable Protocol and Other Validation Program Document Templates • Define Minimal Recommended Tests and Verifications for o Equipment Qualification o Process Validation o Software Validation • Common Pitfalls to Avoid When Executing Validation Protocols • How to Estimate Costs and Time Associated with Validation • How to Respond to Customer and Regulatory Audit Observations Associated with Validation
Areas Covered in the Session:
• Basics Of Validation • The Components of a Sustainable Validation Program • Other Programs that Feed the Validation Program (1 Hour) • Equipment, Utility, and Facility Qualification • Process Validation • Software Validation • Time and Costs of Validation • Responding to Validation and Other Related Audit Findings
Day 1 Schedule: Lecture 1: Understanding the Basics of Validation • Regulatory References • Validation Terminology Lecture 2: The Components of a Sustainable Validation Program • Design Qualification • FATs and SATs • Commissioning • The Validation Master Plan • The Validation Project Plan • Standard Operating Procedures (SOPs) • Protocols • Reports • Additional Software Validation Documents Lecture 3: Other Programs that Feed the Validation Program • Change Control • Complaint Handling • CAPAs • Deviation Management • Maintenance • Sales Lecture 4: Equipment, Utility, and Facility Qualification • The SOP • Protocol Template • Minimal Testing and Verifications for IOQ • Minimal Testing and Verifications for PQ • Facility Qualification • Execution of Protocols • Report Generation Lecture 5: Process Validation • The SOP • Protocol Template • Minimal Testing and Verifications • Execution of Protocols • Report Generation Lecture 6: Software Validation • The SOP • Protocol Template • Additional Software Validation Document Templates • Minimal Testing and Verifications • Execution of Protocols • Report Generation Lecture 7: Time and Costs Associated with Validation • Estimating Time Associated with Each "Deliverable" • Hidden Costs of Validation • Estimating Costs of Using Validation Consultants • How to Recoup Costs Associated with Validation for Contract Manufacturers Lecture 8: Responding to Audit Findings Associated with Validation Day 2 Schedule: Lecture 9: Welcome and Day 1 Reinforcement Lecture 10: Practical Application # 1 -Equipment Qualification Lecture 11: Practical Application # 2 - 483 Responses Lecture 12: Closing Comments Individual/Open Q&A Session
Speaker:
David R. Dills Regulatory Affairs & Compliance Consultant, David R. Dills Regulatory Affairs & Compliance Consultant currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems.
Date: December 10th & 11th, 2015, Time: 9:00 AM to 6:00 PM Price: $1,695.00 (Seminar for One Delegate - Without Stay) & Price: $2,095.00 (Seminar for One Delegate - With Stay)
Register now and save $200. (Early Bird) Until November 22, Early Bird Price: $1,695.00 from November 23 to December 08, Regular Price: $1,895.00 Until November 22, Early Bird Price: $2,095.00 from November 23 to December 08, Regular Price: $2,295.00
Quick Contact: NetZealous DBA as GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com
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