GMP Compliance for Quality Laboratory Operations

Date:   7/26/2012 to 7/27/2012
Time:   8:30am to 4:30pm each day
Instructor:   John Y. Lee
Location:   Planet Hollywood Resort & Casino, Las Vegas, NV

Course Description

This course reviews the GMP requirements, and their interpretation and application to quality control chemistry and microbiology laboratory operations. The topics include the essential laboratory systems, programs and procedures, the current GMP compliance issues, and the FDA's expectations for laboratory systems and controls.

Course Outline

  • USP Interpretations
  • Laboratory Walk-through Inspection Coverage
  • General GMP Requirements and Laboratory Controls
    • Samples, reagents and reference standards
    • Instrument calibration, maintenance, qualification and logbooks
    • Investigations and change control
    • Personnel qualification and training
    • Stability program
    • Raw material reduced testing program
    • Retention sample program
  • Microbiology Laboratory Controls
    • Media control and media growth promotion, sterility testing, methods validation
  • Laboratory Procedures and Documentation
    • SOPs, raw data, electronic records
  • Laboratory Data Integrity Case Studies
  • Analytical Methods Validation
  • Laboratory OOS: Investigation and Retesting

Who Should Attend?

This course is intended for the Quality Control, Quality Assurance and Compliance professionals who are directly involved with laboratory operations, or responsible for the compliance and auditing of laboratory systems and controls. The information in this course may be beneficial for Regulatory Affairs professionals who are responsible for FDA submissions.

Fees
Seminar Fee Discounted Fee*
cGMP: Interpretation & Application
 $2,950.00 $2,800.00
GMP Compliance for Quality Laboratory Operations $2,100.00 $1,950.00

*Discounted Fee applies if you are attending more than one event during the same week, or if you have multiple attendees from the same company location registering at the same time.

Cancellation Policy
  • All cancellations must be received in writing.
  • Cancellations received after June 29, 2012 and up to July 20, 2012 are subject to a $300 service fee.
  • No refunds or credits are issued for cancellations after July 20, 2012, for failure to cancel, or "no shows."
  • Substitutions will be accepted until July 20, 2012.

If for any reason, PharmaNet® decides to cancel these seminars, we are not responsible for covering airfare, hotel or other costs incurred by the registrants.

PharmaNet® reserves the right to modify topics or substitute speakers without notice.