DMCL is dedicated to educate and train Fresher to achieve Excellency through its Industry Oriented curriculum. We offer the best training programs to enable Graduates/Post Graduates to storm the marketplace with the highest possible level of job knowledge and skills which guide them to accomplish worth while career goals and gain a sound return on investment.
Also Impart training to working Professionals on latest trends in Global Pharma & Biotech Industry and upgrade them at par with International standards
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Regulatory Affairs
Module-I - Introduction to the Profession and its overview
Module-II - Regulations in the United States of America
Module-III - Regulatory Systems and Agencies in EU
Module-IV - Regulations in other Countries and Dossiers
Module-V - Important and Critical Notifications for all Regulatory Bodies
Eligibility : B.Pharmacy/M.Pharmacy/ M.Sc/M.Tech Biotech / B.Tech / Post graduates
Duration : 30 days -
ICH-GCP (Clinical Trials)
1. Overview of CRO Industry in India
2. Clinical Research Terminology
3. Medical Terminology
4. Introduction to Clinical Research
5. Phases of Drug Development
6. Evolution of Ethics in Bio-Medical Research
7. Ethics
8. Informed Consent
9. Protocol
10. Investigator Brochure (IB)
11. Case Report Form-I
12. Forms and logs
13. e-CRF
14. Monitoring Responsibilities
15. Responsibilities of Investigator
16. Pharma co Vigilance-I
17. IND 21 CFR.312
18. Sponsor Responsibilities
19. Data Management
20. Fraud in Clinical Research
21. Responsibilities of CRA
22. Preparations of Study Reports
23. Scheduled 'Y'
24. IVRS & Conflict of Interest
25. Project Management
26. ICH-GCP Guidelines
27. FDA Guidelines
Eligibility : B.Pharmacy / M.Pharmacy / B. Sc / M. Sc (Life sciences), MBBS, M.D / B. Tech (Bio tech)
Duration : 30 - 40 days -
HPLC / GC / UV / IR
1. Introduction To Pharma Industry
2. Basics Of cGMP
3. Basic Principles & Procedures Of HPLC/GC
4. System Suitability
5. Instrument Handling
6. Trouble Shooting Of HPLC/GC
7. Calibration Procedures
8. Method Validation Procedures
9. SOP Preparation
10. Examination
11. Mock Interview
12. Interview Skills
Eligibility : Freshers (B.Sc / M.Sc / B.Pharm / M.Pharm) 0-5 yrs Experience in Pharma Industry -
IPR
1. Introduction to Intellectual property rights
2. Role of IPRs: How to prepare your organization
3. All about Patents
4. TRIPS: Trade related Intellectual Property rights
5. Important Key Issues in IPR
6. Searching Patent Information: How to?
7. Trademarks, Copyrights and other forms of IPR : Governing Laws
8. Case Studies
Duration : 30 Days -
cGMP
Course Agenda
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