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Seminar on Modern Approaches to Process Validation: Requirements for Process Design, Design of Facilities and the Qualification of Equipment and Utilities at Mumbai

Event Details

Seminar on Modern Approaches to Process Validation: Requirements for Process Design, Design of Facilities and the Qualification of Equipment and Utilities at Mumbai

Time: February 4, 2016 at 9am to February 5, 2016 at 6pm
Location: The LaLiT Mumbai
Street: Sahar Airport Road, Andheri East, Mumbai - 400059
City/Town: Mumbai
Website or Map: https://www.globalcompliancep…
Phone: 080-325-28001
Event Type: seminar, pharma, medical, process, validation
Organized By: John Robinson
Latest Activity: Dec 9, 2015

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Event Description

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? 

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
    • Equipment Qualification
    • Process Validation
    • Software 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

Who Will Benefit:

  • Internal Auditors
  • Regulators
  • Legal Departments
  • Compliance Officers
  • Validation Managers
  • QC Managers
  • QA Managers
  • Facilities and Engineering Department Staff

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: February 4th and 5th, 2016                    Time: 9 AM to 6 PM

Venue: The LaLiT Mumbai 

Venue Address: The LaLiT Mumbai,

Sahar Airport Road, Andheri East, Mumbai, Maharashtra – 400059

Price: ₹ 14,000

Register now and save 2000 (Early Bird)

Until January 10, Early Bird Price: 14,000 from January 11 to February 02, Regular Price: 16,000

 

Contact Address:

NetZealous DBA GlobalCompliancePanel

 

Phone: 080-325-28001

Fax: 080-25149544 

Email: customersupport@globalcompliancepanel.com

Website: http://www.globalcompliancepanel.in

Registration Links - http://bit.ly/Modern-Approaches-to-Process-Validation

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