InstructorRoyed Training
TypeOnline Course
Price$690 / 34500 INR.
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pharmaceutical production and operation management

Introduction

Features

Nature of course

Course Duration

Eligibility

Certification

Career in Pharmaceutical Production

Pharmaceutical Production and operation management

PG Certification in Pharmaceutical Production and operation Management is training on providing pharmaceutical plant operation management. Therefore, this course provides extensive training for executives and managers working in pharmaceutical plant. Hence, the objective of this course is to provide practical knowledge of the functionalities of production related jobs  and decision making skills. Most importantly, this course provides 360 degree learning in all essential aspects of drugs, quality, regulatory, manufacturing, management, export business management. In conclusion, this online course covers all important areas what a pharmaceutical production professionals requires exposure.

Course Code: RYD-084

Course Title: PG Certification in Pharmaceutical Production and Operation Management [PGPPOM]

This online certification course provides comprehensive study material  covering all important aspects of Pharmaceutical Production and operation management. 

One of the major distinguishing features of this course is the industry database of SOPs. This Pharmaceutical Production management course provides 300s fully developed SOPs covering different pharmaceutical production plant management activities. 

The course provides access to specialized modules covering all Pharmaceutical Dosage Forms. 

Most importantly, the course covers specialized modules on GMP, ISO guidelines as well as handling of GMP and ISO audits. Moreover, this course comes with exclusive hands-on training on plant inspections and audits. Various issues like 483, regulatory queries handling and data integrity are covered in this course. 

Above all, the course covers the special modules on Production related regulatory affairs. It covers dossier preparation, filing requirements and export management procedure for better understanding.

Online distance learning course. Hence, this course can be accessed online across anywhere 24×7. Moreover, you can attend the course at your convenience in your flexible time. For example, you want to attend the session at your 11 pm at night, you can do that.

1 Year

Any body who wants to acquire drug regulatory affairs competency should attend the course.

Certificate will be provided at the end of the successful completion of the course

Careers in Pharmaceutical Production Management

Industrial production management is directly related to the output of the goods and services. Hence, production and operation management deals with management of raw material, machinery and labour to produce the desired goods or services. If we control the production process, it will lead to the effective quality and quantity of the products. In fact, that is the key for organization success. 

Industrial production managers do various diverse functions. They are responsible for production schedule and staffing, procurement and maintenance of equipment, quality control and coordination of production activities among different departments. 

Moreover, production managers control the overall production process. Hence, 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 the Production Manager should be able to handle the export requirement. They are responsible for managing the approval of pharmaceuticals in various countries.   Therefore, it is mandatory to have working knowledge of Regulatory Affairs. Hence, a detailed understanding of dossier preparation, DMF, GMP norms, plant inspections and audits are of great importance.

Opportunity Area

In recent times, with strengthening of domestic and international regulatory standards, new drug discovery & formulation development, quality requirements as well as strengthening of the marketing approval of pharmaceutical products. Hence, there is high demand in the pharmaceutical industry for qualified and well knowledgeable production managers.

Indeed there is a huge scope for Production Manager in pharmaceutical companies. Every Pharmaceutical company who is having its own manufacturing plant requires a professional production manager. Knowledgeable and well trained production professionals help organizations to beat the competition. And more importantly, strict regulation on quality of medicine compelled manufacturers to hire skilled and qualified production managers. They help the pharmaceutical plant to maintain high productivity, economies of scale as well as quality standards to survive in the industry.

Section 1Pharmaceutical R&D and Drug Discovery
Lecture 1Introduction to course
Lecture 2Pharmaceutical R&D Process and Drug Discovery
Lecture 3Investigational New Drug Application (INDA)
Lecture 4New Drug Application (NDA) 
Lecture 5Basic concept and understanding of the Generic Drug
Lecture 6Review on Drug Discovery and Development 
Lecture 7Complete Response Letter | Key understanding | Management and Action Plan
Lecture 8Authorized Generics: Key Understanding
Lecture 9Exploratory IND Vs. Traditional IND
Section 2Production Management Skill Training
Lecture 10P1 Introduction to Production Management
Lecture 11P2 Types of Production & Classification 
Lecture 12P3 Productivity Concept of measuring success
Lecture 13P4 Factors affecting productivity
Lecture 14P5 Industrial efficiency 
Lecture 15P6 Concept of Efficiency, Effectiveness and Productivity
Lecture 16P7 Review Test
Lecture 17P8 Introduction to ERGONOMICS
Lecture 18P9 Concept of work designing
Lecture 19P10 Production Planning - Objective and Importance
Lecture 20P11 Production Planning Steps and Control
Lecture 21P12 Control Chart
Lecture 22P13 Quality Control
Lecture 23P14 PLANT LOCATION  & WEBER’S DEDUCTIVE THEORY
Lecture 24P15 Plant Layout
Lecture 25P16 Material Management
Lecture 26Inventory Management
Section 3Plant Management and Certification Handling
Lecture 27Certification Pharmaceutical Companies / Plants
Lecture 28G1 Lecture Premises & Plant Layout Designing
Lecture 29G2 Lecture Sanitation and Hygiene
Lecture 30G3 Lecture Equipment Modules
Lecture 31G4 Lecture Production Modules
Lecture 32G5 Lecture Documentation
Lecture 33G6 Lecture Quality Control
Lecture 34G7 Lecture Product Complaint
Lecture 35G8 Lecture Storage Module
Lecture 36ISO and ISO Audits
Lecture 37Pharmaceutical SOPs Management from regulatory perspective
Lecture 38Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 39Data Integrity issues in Pharmaceutical Industry
Lecture 40Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 41Download Plant Documents - SOPs and Other important documents [Open formats]
Section 4Export Management Training for Production Manager
Lecture 42Introduction to Pharmaceutical Export
Lecture 43Introduction of Export Documentation | Understanding of important terminologies
Lecture 44Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 45Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 46Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 47Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 48Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 49Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 50LC Discounting | How it works | How to calculate the LC discounting
Lecture 51Packing List | Importance | Things to include in packing list
Lecture 52Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 53Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 54Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 55Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 56Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Section 5Finance for Non-finance Managers