#1
27th October 2014, 12:01 PM
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GMP Auditor Courses
I want to do GMP Auditor Course. Would you please tell me about GMP Auditor Courses.
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#2
27th October 2014, 01:17 PM
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Re: GMP Auditor Courses
Auditing is a important role inside a pharmaceutical company. It presents administration with detail info. on the subject of how successfully the group run the excellence of their method and goods. Auditors should make their jobs expertly to make sure their company’s observance with pharmaceutical USFDA GMP regulations and other quality standards like ICH Q10. Auditing for GMP is particularly planned to deal with the confront of GMP auditing for the pharmaceutical industry. COURSE ELIGIBILITY: Eligibility : B.Pharm, M Pharm, BSc., MSc., B Chem, M Chem, Doctorates in science disciplines, BE, DE. DURATION : 10 MONTHS COURSE PROGRAMME: Part 1: Auditing Basics Purpose of audits and audit models (overview) Role Characteristics of the Auditor Audit Types and Classification Audit Methods General Themes for All Audits Part 2: Auditing Tools and Techniques Basic auditing tools Audit Techniques Audit scheduling, planning and management Part 3: The audit process Audit scheduling Conducting the audit Managing an Audit Team The Exit Meeting Audit Reporting and closeout Part 4: Improving the audit system Adding Value from the Audit programme Organisation of the internal audit programme (Self Inspection) Part 5: How to Audit CAPA, OOS and QRM The necessity for structured investigation Corrective and Preventive Action procedures Out of Specification procedures Risk Assessment techniques Part 6: Auditing API Manufacturers Why Audit API Manufacturers What is different about API operations" Control of raw materials and process intermediates Handling Manufacturing Deviations QC Laboratories Distribution Computer systems QP Declaration Part 7: Auditing Products Manufacturers Oral solid and liquid dosage forms Packaging and labelling Distribution QC Laboratories Computer systems Part 8: Auditing for Approval of Contractors / Suppliers Technical requirements (physical properties, purity, quantity, frequency, etc) Critical steps and controls Preferred location (UK, EU, Far East, world-wide) Key points of contract (Quality Technical Agreement) Following Is the institute that Offer GMP Auditor Course: CONTACT DETAIL: Pharma Courses Ltd Suite 1327 Kemp House 152 City Road London EC1V 2NX Telephone +44 (0)20 71937703 |
#3
21st March 2015, 03:26 PM
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Re: GMP Auditor Courses
Can you list me the names of courses that offered under Good Manufacturing Practices (GMP) as I want to take admission in it? List me the names of some good institutes that offer the courses?
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#4
21st March 2015, 03:35 PM
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Re: GMP Auditor Courses
Good manufacturing practices (GMP) are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public. International Society for Pharmaceutical Engineering No. 2236 Chino Roces Avenue 1231, Philippines University College Cork Coláiste Na Hollscoile, Bóthar an Choláiste, Corcaigh, Ireland PharmaTraining Ltd 152 City Road, London EC1V 2NX, United Kingdom ISPE 600 N. Westshore Blvd., Suite 900 Tampa, Florida 33609 USA ISPE China Level 4, Puxi Management Center, No. 801 Jumen Road Shanghai 200023, China – Ontario College of Technology 4002 Sheppard Ave. East, Suite 308 Toronto, Ontario, Canada M1S 1S6 The Center for Professional Advancement 190 Rt. 18 Suite 203 East Brunswick, NJ USA 08816 NIHR Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust and King's College London 16th Floor Tower Wing Guy’s Hospital London SE1 9RT GMP Training Courses Quality Systems Facilities and Equipment Systems Materials Systems Production Systems Packaging and Labeling Systems Laboratory Control Systems Certified Process Validation Professional (CPVP) Current Good Manufacturing Practices (cGMP) Certified Professional (GMPCP) Pharmaceutical Development Certified Professional (PDCP) cGMP Quality Principles Effective Risk-Based Applications of Drug cGMPs Good Manufacturing Practices (cGMP) |
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