Facilitation, Validation, Qc, and Qa detail syllabus for Nanoelectronics (Nano), 2017 scheme is taken from VTU official website and presented for VTU students. The course code (17NT744), and for exam duration, Teaching Hr/week, Practical Hr/week, Total Marks, internal marks, theory marks, duration and credits do visit complete sem subjects post given below.
For all other nano 7th sem syllabus for be 2017 scheme vtu you can visit Nano 7th Sem syllabus for BE 2017 Scheme VTU Subjects. For all other Professional Elective-III subjects do refer to Professional Elective-III. The detail syllabus for facilitation, validation, qc, and qa is as follows.
Course Objectives:
As a graduate of this program you will have learned how to do the following:
- To Perform a variety of Quality Control activities including developing QC policies and Standard Operation Procedures
- To Identify and analyze unexpected results during routine analyses and help to provide solutions based on scientific and regulatory considerations by implementing preventive action and corrective actions programs.
- To understand the concept of quality systems and compliance in the regulated industry and the role of quality assurance.
- To understand the use of controlled documentation.
- To know about ISO series of Standards
Module 1:
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Module 2:
UTILITIES VALIDATION AND ANALYTICAL METHOD VALIDATION Validation of water system- for production of DM water, distilled water, Validation of Air handling Units- classification of environment (class 100, 10,000, 1,00,000), Performance qualification &
parameter of cleanliness such as number of airborne particles, microbes filter integrity test of HEPA filter, air velocity, air flow pattern, no. of air changes, pressure differentials etc. Analytical Method Validation: Recommendation of ICH guidelineDefinition of accuracy, precision, linearity, Limit of Detection, Limit of Quantification, range, robustness, ruggedness, specificity, system suitability test. USP requirement of analytical validation- different category of assays.
Module 3:
PLANNING AND VALIDATION ISO 9000 Series & International Harmonization & their effect upon GMP’s, Planning & Managing a Validation Program including Change Control, Scale-Up and Post-Approval Changes (SUPAC), Validation of Water & Thermal Systems, including HVAC Facilities & Cleaning Validation. Validation of Active Pharmaceutical Ingredients (APIs) & Aseptic Processes. Validation of Non-Sterile Processes (used in the manufacture of Solids, Liquids, & Semisolid Dosage Forms). Overview of methods of evolution, FDA and ICH guidelines, Development and validation, sample preparation, separations, Minimum detectable amount
Module 4:
For complete syllabus and results, class timetable and more pls download iStudy. Its a light weight, easy to use, no images, no pdfs platform to make students life easier.
Module 5:
QUALITY CONTROL, QUALITY ASSURANCE AND MANAGEMENT Objectives of QC, Customer Satisfaction, Capability; Terms Relating to Management, Management System, Quality Management System, Quality Policy, Quality Planning, Quality Control, Quality Assurance, Quality Improvement, Continual Improvement, Effectiveness, Efficiency; Relating to Process and Product, Process, Product, Procedure; Terms relating to Characteristics, Quality Characteristics; Terms Relating to Conformity, Non-Conformity, Defect, Preventive Action, Corrective Action, Correction, Rework, Repair, Scrap, Concession, Deviation Permit, Release; Terms Relating to Documentation, Information, Document, Specification, Quality Manual, Quality Plan, Record; Terms Relating of Examination, Objective Evidence, Inspection, Test, Metrological Confirmation. The development of regulatory requirements for validation, Impact Assessment; Failure Mode and Effects Analysis (FMEA), Contamination Control
Course Outcomes:
- Describe the validation, Quality control, Quality Assurance
- Understand the importance of GAMP and ISO standards
- Explain the implementation of control measures taken in process and product development
- Identify the objectives of Quality control, Quality Assurance and management
Graduate Attributes (as per NBA):
- Engineering Knowledge.
- Problem Analysis.
- Design / development of solutions (partly).
- Interpretation of data.
Question paper pattern:
- The question paper will have ten questions.
- Each full Question consisting of 20 marks
- There will be 2 full questions (with a maximum of four sub questions) from each module.
- Each full question will have sub questions covering all the topics under a module.
- The students will have to answer 5 full questions, selecting one full question from each module.
Text Books:
- Total Quality Management- Guiding Principle for Application, J. P. Peker, ASTM manual series, Philadelphia.
- Total Quality Management – The Key to Business Improvement, Champman and Hall, Londan.
- Quality Assurance Guide by Organisation of Pharmaceutical products of India.
- ISO 9000 and Total Quality Management – Sadhank. G. Ghosh
- ISO 9000 Quality Systems Handbook – updated for the ISO 9001:2008 standard, Sixth Edition: Using the standards as a framework for business improvement by David Hoyle, 2009.
Reference Books:
- R. Nash and Wachter, Pharmaceutical Process Validation. Volume 129, Latest Edition. Marcel Dekker Inc., New York.
- Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing, Current Good Manufacturing Practice-USFDA.
- www.fda.org
- US-FDA guideline for bio analytical studies. Dekker Inc., New York
- Juran’s Quality Handbook, 5th Ed, by J M Juran, A B Godfrey, McGrawHill International Edition
- Total quality management: strategies and techniques proven at today’s most successful companies (Portable Mba Series) by Stephen George and Arnold Weimerskirch, 1998.
For detail syllabus of all other subjects of BE Nano, 2017 regulation do visit Nano 7th Sem syllabus for 2017 Regulation.
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