Session 1 : Pharmaceutical Industry Overview
Session 2 : Drug Development Process
Session 3 : Pharmacology
Session 4 : Present CGMP challenges, issues, and problems.
Session 5 : History of Food, drug and Cosmetic Act.
Session 6 : History Of Food, Drug And Cosmetic Act Continues… Question and Answer period.
General Introduction to FDA
Session 7 : Jargon of CGMP compliance: An abbreviation and acronym Primer the Essential Habits of cGMP Compliance the costs of non- Compliance
Session 8 : A brief introduction to FDA & How the cGMPs fit into the regulatory Picture.
Comprehensive review and explanation of the U.S. cGMPs:
Session 9 : Part 210
Session 10 : Part 211 Subpart A: General Provisions
Session 11 : Part 211 Subpart B: Organization and Personnel
Session 12 : Part 211 Subpart C: Buildings and Facilities
Session 13 : Part 211 Subpart D: Equipment
Session 14 : Part 211 Subpart E: Control of components and Drug Product Containers and Closures.
Session 15 : Part 211 Subpart F: Production and process Controls
Session 16 : Part 211 Subpart G: Packaging and labeling Control
Session 17 : Part 211 Subpart H: Holding and Distribution
Session 18 : Part 211 Subpart I: Laboratory Controls
Session 19 : Part 211 Subpart I: Laboratory Controls continued…
Session 20 : Part 211 Subpart J: Records and Reports
Session 21 : Part 211 Subpart K: Returned and Salvaged Drug Products
Session 22 : The what, why, where, and when of FDA guidance documents
Session 23 : The International Conference on Harmonization (ICH): what it is and why you need to keep up with its activities.
Session 24 : Schedule M (Indian GMP)
Session 25 : Schedule M (Indian GMP)continued…Question and Answer Period
Session 26 : Overview of other GMPs: MCC - South Africa; TGA - Australia; ANVISA - Brazil; EMEA - Europe; MHRA UK;TPD- Canada
Session 27 : Handling of Deviations and Out Of Specification Results.
Session 28 : Generation of Raw Material and Finished Product Specification
Session 29 : Analytical Method Validation (ICH -Q2A & Q2B)
Session 30 : Analytical Method Validation (ICH -Q2A & Q2B) continued…….
Drug Development Process
Session 31 : Analytical Method Validation (ICH -Q2A & Q2B) continued…
Session 32 : Process Validation - Prospective Validation
Session 33 : Process Validation - Concurrent Validation
Session 34 : Process Validation - Retrospective &Re-validation Question and Answer Period
Session 35 : Qualification - DQ, IQ, OQ & PQ -Definitions and overview.
Session 36 : Quality Systems approach to CGMP compliance - 6-System inspection model Currently used by FDA
Session 37 : Stability Studies - ICH zones classification
Session 38 : Stability Studies continued…
Instrumentation
Session 39 : Overview of HPLC & GC
Session 40 : Overview of HPLC & GC continued…
Session 41 : Preparation of Mobile phase, buffers etc.
Session 42 : Overview of GC Instrumentation
Session 43 : Overview of HPLC Instrumentation
Session 44 : Overview of HPLC Instrumentation continued…
Session 45 : References and Resources for further study Final Question and Answer Period
Eligibility : Graduates / Post graduates / B.Pharmacy / M.Pharmacy
Duration : 30 days
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