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1st Edition Conference

Lifecycle Management of Analytical Methods and Procedures - According to New FDA and USP guidelines Seminar

29 - 30 Apr 2020 Add To Calendar

About Followers 2 Reviews Exhibitors Photos 4 Speakers 1 Travel Deals

"Managing the lifecycle of analytical methods"
Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the regulated industry to have procedures in place to ensure suitable levels of reliability, accuracy and precision of such methods. The procedures should cover lifecycle phases from design, development, validation to on-going routine use. Managing analytical methods and procedures according to the lifecycle approach has been recommended in recent FDA guidance documents and stimuli articles published by the USP. For example, the recent FDA guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” contains a section on Lifecycle Management of Analytical Procedures.

Highlights

  • Be able to develop a strategy for analytical procedure lifecycle management
  • Understand risk management strategies throughout the procedure lifecycle
  • Be able to justify and document decisions about type and extend of revalidation after method changes
  • Be able to define and demonstrate FDA, EU, USP and ICH compliance to auditors and inspectors
  • Be able to develop inspection-ready documentation during on-going routine operation

Timings

8:30 AM - 4:30 PM (Feb 03) (General)
8:30 AM - 4:00 PM (Feb 04) (General)

Entry Fees

Paid Ticket Starts from 2099 USD View Details

Participants

20
Delegates

5 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma
Education & Training

Editions

29 - 30 Apr 2020 Interested


Frequency Bi-annual

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Organizer

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ComplianceOnline USA

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User Community [ Users who have shown interest for this Event ]

Ali Zaidi

Ali Zaidi

Head of Sales at TruckX

San Francisco, United States
sara rigante

sara rigante

Project Manager at merck serono

Geneva, Switzerland

Speakers

Speaker
Mark Powell

Mark Powell

Director

Visitor Ticket Price Buy Now

2099 USDAttendee Seminar One Registration
47.377000 8.542000

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Zürich, Switzerland

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