Seminar on GMP Compliance for Pharmaceutical Quality Control Laboratories at Singapore

Overview:

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.
  
  

Agenda:

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.
• Dietary supplements authority

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

• The general ICH requirements.
• Special needs for non-standard procedures.
• Statistical requirements.

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.

Location: Singapore Date: January 21st & 22nd, 2016 Time: 9 AM to 6 PM 

Venue: Mandarin Orchard Singapore

Address:   333 Orchard Road, Singapore 238867

Registration Details:

NetZealous LLC - DBA GlobalCompliancePanel

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA         

USA Phone: 1-800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com  

http://www.globalcompliancepanel.com

Registration Link - http://bit.ly/GMP-compliance-pharmaceutical