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1st Edition  Conference

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


"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 .. continue reading 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.This 2-day workshop will explain the background to the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommended approaches. Interactive exercises will be included in the workshop.

Highlights

  • Be able to develop a strategy for analytical procedure lifecycle management,
  • 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
  • Understand what questions will be asked during audits and inspections and how to answer them

Timings

8:30 AM - 4:30 PM (Sep 16) (General)
8:30 AM - 4:00 PM (Sep 17) (General)

Entry Fees

Paid Ticket Starts from 1899 USD View Details

Participants

20 Delegates
5 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma
Education & Training

Editions

16-17 Sep 2019 Interested


Frequency Bi-annual

Official Links

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Organizer

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ComplianceOnline USA

Top Rated 338 events listed

Speakers

Speaker
Mark Powell

Mark Powell

#Training and #consultancy services in #analytical #chemistry

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1899 USDAttendee Seminar One Registration
42.355082 -71.055722

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Boston College Club

100 Federal Street 36th Floor, Boston, MA 02210
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