10times
1st Edition  Conference

GMP Compliance for Quality Control and Contract Laboratories


"Analytical method validation"
This program will cover the requirements for laboratory controls under US GMP regulations and compare them to those applied by other international health regulatory authorities. Laboratory controls relating to equipment calibration and preventive maintenance; sample chain of custody; good documentation practices; investigation of out of specification and out of trend results; analytical method validation; change control; impact of staffing levels and work flow patterns in the lab on GMP compliance; training and other issues will be included under laboratory controls. The program will also examine the impact of the benchmark court ruling in US versus Barr Laboratories on QC laboratory governance under GMP; the role of the QC Laboratory; its placement in the overall organizational structure of a company; the responsibility of a contract laboratory versus an in-house laboratory.

Highlights

  • Introductions and setting of attendee’s objectives – What do you want to get from this seminar?
  • Basics of FDA law and regulations for QC laboratories,Documentation and record-keeping requirements
  • Compare topics covered to attendee objectives stated on day one,Stability (shelf-life) studies
  • Proper conduct of laboratory out of specification/out of trend investigations
  • Consequences of laboratory non-compliance – enforcement basics,Final Q&A and open discussion

Timings

8:30 AM - 4:30 PM (Aug 19) (General)
8:30 AM - 4:30 PM (Aug 20) (General)

Entry Fees

Paid Ticket Starts from 1699 USD View Details

Participants

20 Delegates
5 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma
Education & Training

Editions

19-20 Aug 2019 Interested


Frequency Bi-annual

Official Links

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ComplianceOnline USA

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1699 USDAttendee Seminar One Registration
39.953000 -75.165000

Venue Map & Directions

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Venue to be announced

Philadelphia, USA

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