Pharmaceutical Quality Control 2015 - Singapore Conference on Good Manufacturing Practice Compliance for Pharmaceutical Quality Control Laboratories

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.
Areas Covered in the Session:
? FDA's legal authority and limitations
? FDA labeling requirements and exemptions
? FDA guidance documents, such as for social media, direct -to-consumer advertising, message formatting and providing risk/benefit information
? Motivational factors in decision making
? FDA-wide Warning Letters
? Enforcement
? Mock marketing strategy exercise
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.
o 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.
Speaker:
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 t0065sting 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 Date: November 12th and 13th, 2015 Time: 9 AM to 6 PM
Venue: Mandarin Orchard Singapore
Address: 333 Orchard Road, Singapore 238867
Price: $1,895.00 (Without Stay for One Delegate)
Price: $2,295.00 (With Stay for One Delegate)
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-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Registration Link - http://bit.ly/1M5wVwm