Become a Complete Pharma Professional
Course Content
Overview of Pharmaceutical Industry
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Overview of pharmaceutical industry and its role in healthcare system
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Career options in pharmaceutical industry
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Different functional departments and their role in pharmaceutical industry
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Good Industrial Practices Discipline, personal behavior, and personal safety Human skills Goal setting. Motivation, Time management, communications & Team work.
Quality Management System overview (QMS)
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Schedule-M, WHO GMP, EU guidelines and USFDA guidelines.
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Quality assurance - Role and responsibilities
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Batch reconciliation and Finished goods release
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Sanitization and hygiene
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Complaints and recall
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Contract production and analysis
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Self inspection and quality audits Personnel Training
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Personal hygiene, Premises, equipment and materials
Quality Control
Explanation of Intra Departmental Divisions (Wet Lab, Instrumentation & Microbiology.)
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Chemical and physical analysis
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Instrumental analysis(GC, HPLC, UV, HPTLC, Dissolution)
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Standards (RS and WRS) Good laboratory practices
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Application of microbiology in pharmaceutical testing
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Impurities (known and unknown) : ICH guideline
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Calibration of instruments
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Packing material analysis
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Deviations Planned and Unplanned
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Post release monitoring-complaints, recalls
QMS Elements
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Change Control
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Deviation-(planned and unplanned)
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Incident
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CAPA
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Handling of non-conformance
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Out of specification (OOS)
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Market recalls
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Market complaints
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Material systems
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Production system
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Laboratory control systems
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Facilities and equipment systems
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Packaging and labeling system
Manufacturing and Packing of Drugs
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cGMP of Pharmaceutical manufacturing
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Evolution and Principles of cGMP, Schedule-M, WHO-GMP requirements, EU and USFDA guidelines
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Manufacturing of Dosage Forms
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cGMP complied manufacturing and documentation aspects including Environmental monitoring Cleaning (Equipment, Area, Environment), BMR, Process flow, in-process checks and FP analysis
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Machinery details and Process steps involved in Manufacturing of Tablets, Capsules, Liquid Orals , Parenterals/ Injectables/ Semisolids/ Ointments
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cGMP complied packaging and documentation aspects including BPR Process flow, in-process checks, and FP analysis. Labeling requirements for Tablets, Capsules, Liquid Orals, Parenterals / Injectables, and Semisolids / Ointments
Research & Development
Drug discovery and development process
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Drug discovery and development algorithm
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Clinical research process
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New drug delivery system
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Understanding on IND, NDA, ANDA/Dossiers
Generic Product Development and registration
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Requirements for registration and approval
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Pre-formulation and formulation development activities
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Analytical method development
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Process/method/cleaning validation
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Technology transfer methods
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BE studies for IR and MR products
Design and Development of per oral novel drug delivery systems
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Scientific principles involved in the design of novel drug delivery systems(NDDS)
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Concepts of life-cycle management with NDDS
Drug Regulatory Affairs
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Requirements for registration and approval of generic products for USFDA (ANDA), EU/AU/SA (Dossier), and TPD (ANDS), etc
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ICH guidelines
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Registration of pharmaceuticals
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Domestic
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Regulated markets ANDAs, DMFs, eCTDs
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BA/BE studies and CRO
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Dossier preparation, submission, approval & maintenance
ELIGIBILITY
* Freshers D.Pharmacy/B.Pharmacy / M.Pharmacy
* 1 - 3 Years Pharma Experienced
* Career Gap Candidates
* Others who are willing to settle in Pharma Industry
SESSION DETAILS
Duration : 30 - 45 Days
Timings: 2 Hrs/Day
Weekend Batches : Full Day (2 Sessions)
Fast Track : 10 Days (For Experienced Only)
BENEFITS
* Practical Knowledge on Pharma Functions
* Placement Assistance
* Training Certificate
* Soft Copy of material
Practical Training is the advanced level of learning to start a bright career
(The Next Level Education Platform)