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pharma production management course







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pharmaceutical production management course

Advanced Diploma  in Pharmaceutical Production Management trains Production Managers working in pharma formulation plant. Hence, this course provides hands on practical managerial training for executives who want to enhance the skills of production management. Therefore, this course provides practical knowledge of the functionalities of production related jobs and inculcate the turnkey decision making skills.

  • Course Code: KPE-C-005
  • Course: KPE’s Advance Diploma in Pharmaceutical Production Management 
  • Nature of the Course: Distance & e-Learning; Self paced learning

Course features

  • Comprehensive study material  covering all important aspects of Pharmaceutical Production
  • Access to industry data bank of Standard Operating Procedures (SOPs) for different equipments
  • Specialized modules covering all Pharmaceutical Dosage Forms
  • Specialized modules on GMP, ISO guidelines as well as handling of GMP and ISO audits
  • Special module on Production related regulatory affairs
  • Latest Pharma Industry Newsletters View
  • Support : Resume Development

B.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in pharmaceutical marketing can pursue the course.

1 Year

PILOT PLANT AND SCALE-UP TECHNIQUES – Pharmaceutical Pilot plant – Pilot plant design – Case studies for tablets – Capsules – Aerosols – Liquid orals – Parenterals – Sustained release preparation – Semi-solid preparation – Basic requirements – Design of product – Facility – Equipment selection and personnel.

Production systems – Production department – Production process routing and loading –Scheduling – Despatching of records – Production control.
FORMULATION PRODUCTION MANAGEMENT – Plant site selection and layout – Material handling for various pharmaceutical products – Service facilities – Preventive maintenance in pharmaceutical companies – Group andindividual replacement.
MATERIAL MANAGEMENT– Materials – Quality and quantity – Value analysis – Purchasing – Centralized and decentralized – Vendor development – Buying techniques – Purchasing cycle and procedures – Stores management – Salvaging and disposal of scrap surplus – Selective inventory control – RQM and EOQ – Modern inventory management systems – Cost and savings in inventory.
HUMAN RESOURCE DEVELOPMENT – Human resource planning – Job analysis and design – Recruitment – Personnel selection – Orientation and placement – Training and development – Supervision – Performance appraisal – Remuneration and salaries – Compensation – Industrial relations – Motivation – Labour welfare.
Real life exposure to SOP management system with 400 real life SOPs operating in pharma industry.
GMP and GMP documentations and handling of GMP audit .
Detailed study on the Drug Regulatory Affairs with exposure to drug registration in different countries.
Pharmaceutical Formulation and Manufacturing Project Management skill training
Special module on setting up of the pharmaceutical production plant

Basic Training on Drug Regulatory affairs and training on drug dossier preparation. 

Special module on export documentation. 

Careers in Pharmaceutical Production Management:

Industrial production management is concerned with the organization of raw material, machinery and labour to produce the desired goods or services along with taking care of quality and quantity of the products so produced. Industrial production managers are responsible for production schedule and staffing, procurement and maintenance of equipment, quality control and coordination of production activities among different departments. While controlling the overall production process they also take care of economic efficiency and in-time delivery of the goods and services so produced. Besides, they should be aware of the recent market trends and the resultant change in the demand pattern. Also Production Manager should able to handle the export requirement, therefore working knowledge of the Regulatory Affairs (e.g dossier preparation, DMF, GMP norms) are of importance.

Opportunity Area in Pharmaceutical Production Management

With strengthening of domestic and international regulatory standards, new drug discovery & formulation development, quality requirements as well strengthening of the marketing approval of pharmaceutical products, there is high demand in pharmaceutical industry for qualified and well knowledge production managers in production department of the company.

Large pool of manufacturers, high competition and strict regulation on quality of medicine compelled manufacturers to hire skilled, qualified, and well knowledgable production managers to maintain high productivity, economies of scale as well as quality standards to survive in the industry.

This course will give a huge value addition to your professional career. As production manager, you must be knowing important aspects of regulatory affairs including, GMP, GCP, ISO as well as Handling of Audit, standards of  international regulations like ICH, USFDA, CDSCO etc.

This course is designed by industry experts to simulate practical knowledge & skill required by industry with minimal course fees. You will be getting Practical Knowledge of Pharmaceutical Production similarly as Industry require.

We also have Pharmaceutical Production Management and Regulatory Affairs dual specialization course. Entire syllabus of Regulatory Affairs (as a single course) and also Pharmaceutical Production Management topics will be covered under this program. Click here to view the course details.

Section 1Production - Fundamental Topics
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Review on Drug Discovery and Development 
Lecture 6Complete Response Letter | Key understanding | Management and Action Plan
Lecture 7Authorized Generics: Key Understanding
Lecture 8Exploratory IND Vs. Traditional IND
Section 2Production Management - Pharmaceutical Dosage Forms and Manufacturing Process
Lecture 9P1 Introduction to Production Management
Lecture 10P2 Types of Production & Classification 
Lecture 11P3 Productivity Concept of measuring success
Lecture 12P4 Factors affecting productivity
Lecture 13P5 Industrial efficiency 
Lecture 14P6 Concept of Efficiency, Effectiveness and Productivity
Lecture 15P7 Review Test
Lecture 16P8 Introduction to ERGONOMICS
Lecture 17P9 Concept of work designing
Lecture 18P10 Production Planning - Objective and Importance
Lecture 19P11 Production Planning Steps and Control
Lecture 20P12 Control Chart
Lecture 21P13 Quality Control
Lecture 23P15 Plant Layout
Lecture 24P16 Material Management - Introduction
Lecture 25P17 Inventory Management
Section 3Plant Management and Certifications
Lecture 26Certification Pharmaceutical Companies / Plants
Lecture 27G1 Lecture Premises & Plant Layout Designing
Lecture 28G2 Lecture Sanitation and Hygiene
Lecture 29G3 Lecture Equipment Modules
Lecture 30G4 Lecture Production Modules
Lecture 31G5 Lecture Documentation
Lecture 32G6 Lecture Quality Control
Lecture 33G7 Lecture Product Complaint
Lecture 34G8 Lecture Storage Module
Lecture 35ISO and ISO Audits
Lecture 36Pharmaceutical SOPs Management from regulatory perspective
Lecture 37Plant Inspection Management - Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter - Advance Training
Lecture 38Data Integrity issues in Pharmaceutical Industry
Lecture 39Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 40Plant Doc - SOP and other plant documents
Section 4Export Management from Production Manger's Perspective
Lecture 41Introduction to Pharmaceutical Export
Lecture 42Introduction of Export Documentation | Understanding of important terminologies
Lecture 43Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 44Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 45Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 46Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 47Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 48Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 49LC Discounting | How it works | How to calculate the LC discounting
Lecture 50Packing List | Importance | Things to include in packing list
Lecture 51Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 52Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 53Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 54Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 55Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation