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 limitationsFDA labeling requirements and exemptionsFDA guidance documents, such as for social media, direct -to-consumer advertising, message formatting and providing risk/benefit informationMotivational factors in decision makingFDA-wide Warning LettersEnforcementMock marketing strategy exerciseWho will benefit:DirectorsManagersSupervisors, and lead workers in Manufacturing, Quality Control, Regulatory Affairs, and Quality AssuranceWorkers 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 LaboratoriesTypes of testing laboratoriesQuality Agreements are not just for contractors.General regulatory requirements for testing laboratories.Dietary supplements authorityLecture 2:The Biological Testing LaboratoryGeneral problems with biological testing.The Animal Laboratory has special requirements.Lecture 3:The Microbiology LaboratoryGeneral problems encountered in microbiological testing.Validation of microbiological tests.Viruses and mycoplasmasLocation: Singapore Date: November 12th and 13th, 2015 Time: 9 AM to 6 PMVenue: Mandarin Orchard SingaporeAddress: 333 Orchard Road, Singapore 238867Price: $1,895.00 (Without Stay for One Delegate)Price: $2,295.00 (With Stay for One Delegate)Registration Details:NetZealous LLC - DBA GlobalCompliancePanel161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USAUSA Phone: 1-800-447-9407Fax: 302-288-6884