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Posted: 08/08/2016

2 Day In-Person Seminar by Ex-FDA Official on Pharmaceutical cGMP, Data Integrity and FDA Inspections ? Current Challenges and Preparations

COURSE DESCRIPTION What are the Current Good Manufacturing Practice regulations (cGMP) for Finished Pharmaceuticals (cGMP)? Why is it required to follow these regulations? This seminar will provide a review of cGMP regulations with explanations that will demonstrate the benefits of complying with these simple rules. You will learn how to prepare for and what is the appropriate conduct during FDA Inspections. Acquire the suitable skills necessary for responding to FDA?s questions. Descriptions of what records you have to provide and what records you should not provide to FDA. Learn how to write a procedure for preparing for FDA and other regulatory agency inspections. The importance of data integrity and control of electronic records, with particular regards for recent problems with Indian API manufacturers. A comprehensive review of having and following written laboratory investigation procedures. Providing and maintaining adequate audit trails for traceability to your original data. A short role playing exercise will be conducted, which will help you to learn appropriate behavior during regulatory inspections. LEARNING OBJECTIVES ? cGMP for Finished Pharmaceuticals ? cGMP for APIsBuildings & Facilities, Equipment, Control of Components ? Production and Process Controls, Laboratory Controls ? Documentation, Change Control, Process Validation ? Quality Protocols ? Data Integrity ? Electronic Records and Signatures ? FDA Inspection Guides ? Top 10 most common cited FDA Inspectional Observations (cGMP deficiencies) ? Recent FDA Warning Letters ? Indian Pharma and Challenges Ahead WHO WILL BENEFIT A must attend seminar for professionals in Pharmaceutical development and quality control companies, Manufacturers of drug substances (APIs), Finished Products, Contract laboratories and Clinical Research Organizations DEPARTMENTS: ? Quality Control & Quality Assurance ? Research and Development Engineering ? Regulatory Compliance ? Manufacturing and Facilities ? Validation Production ? Documentation Supply Chain and Logistics PROFESSIONALS: ? Vice-Presidents ? Directors ? Senior Managers ? Managers Senior Engineers ? Engineers Supervisors ? Team Leaders ? GMP Training Specialists


Time: 13:00 - 14:00

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