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2-day In-person Seminar

GMP Compliance for Pharmaceutical Quality Control Laboratories


January 21st & 22nd, 2016

Time: 9:00 AM to 6:00 PM

Singapore

Venue: Mandarin Orchard Singapore


Director : Dr. Steven Kuwahara
  (Without stay)   Price: $1,895.00
(Seminar Fee for One Delegate)

  (With stay)   Includes   Price: $2,295.00
(Seminar Fee for One Delegate)


**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

This course will present the regulations and guidelines that apply to operations in quality control testing laboratories. In some cases these will not be specific regulations, but needs that, if met, will increase the efficiency or quality of activities in the laboratory. While it will not be possible to cover all of the subtle variations among regulatory regions, general internationally accepted practices that comply with GMP requirements will be covered.


Why should you attend:

Since quality control is recognized as a manufacturing function, any pharmaceutical worker who deals with the manufacture of products should attend this course in order to gain an understanding of the regulatory requirements that apply to the testing and interpretation of test results as they relate to the monitoring and release of pharmaceutical products. In particular workers in and supervisors of pharmaceutical quality control laboratories will find this course to be of interest. In addition, workers in regulatory affairs and quality assurance will benefit as they will need to understand general GMP requirements when assessing the quality of product lots and presenting test results and process monitoring data to regulatory agencies.


Who will benefit:

  • Directors
  • Managers
  • Supervisors, and lead workers in Manufacturing, Quality Control, Regulatory Affairs, and Quality Assurance
  • Workers who will be participating in operations or the supervision of Quality Control testing or the interpretation of test results.

Day 1 Schedule


Lecture 1:

Introduction to Quality Control Laboratories

  • Types of testing laboratories
  • Quality Agreements are not just for contractors.
  • General regulatory requirements for testing laboratories.

Lecture 2:

The Biological Testing Laboratory

  • General problems with biological testing.
  • The Animal Laboratory has special requirements.

Lecture 3:

The Microbiology Laboratory

  • General problems encountered in microbiological testing.
  • Validation of microbiological tests.
  • Viruses and mycoplasmas

Lecture 4:

Environmental Monitoring

  • General requirements for non-sterile products
  • Aseptic processing for sterile products.
  • Environmental organisms and other material.

Day 2 Schedule


Lecture 5:

Method Validation


Lecture 6:

Unusual and Out-of-Specification Test Results

  • U.S. and other requirements.
  • Specific requirements for the testing laboratory
  • Statistical considerations.

Lecture 7:

Statistical Quality Control (SPC)

  • Methods for monitoring processes
  • SPC is not required but . . . .
  • Setting up and choosing SPC charts.

Lecture 8:

Training Needs for the QC Testing Laboratory

  • There must be proof of adequate training.
  • Protocols and reports
  • Education, training and experience for personnel.
Seminar Pricing Includes (With stay)
2 Days' Stay
Pick-up and Drop Facility (Nearest Airport)
Breakfast and Lunch
High Tea
Pack of 3 Past Webinars on similar subject
Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

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Dr. Steven Kuwahara

Founder & Principal, GXP Biotechnology, LLC

Dr. Steven Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.

Location: Singapore


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