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

Introduction

Features

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 Snapshot

  • Course Code: RYD-084
  • Title of the training: PG Certification in Pharmaceutical Production and Operation Management [PGPPOM]
  • Duration of the Course: 1 Year
  • Nature of the course: 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.
  • Course Certificate: Certificate will be provided at the end of the successful completion of the course.

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.

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 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
Lecture 9Handling of orange book
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
Section 4Export Management Training for Production Manager
Lecture 37Introduction to Pharmaceutical Export
Lecture 38Introduction of Export Documentation | Understanding of important terminologies
Lecture 39Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 40Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 41Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 42Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 43Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 44Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 45LC Discounting | How it works | How to calculate the LC discounting
Lecture 46Packing List | Importance | Things to include in packing list
Lecture 47Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 48Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 49Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 50Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 51Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Section 5Chemistry Manufacturing Control
Lecture 52Chemistry, Manufacturing & Controls 
Lecture 53Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 54505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 55Advance Learning on 505B2 Pathway
Section 6Dossier Management and Filing
Lecture 56Introduction to Common Technical Document (CTD)
Lecture 57CMC Dossier & Compliance Management
Lecture 58Electronic Common Technical Document (ECTD)
Lecture 59Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 60Importance of effective dossier management
Lecture 61Discussion on 85 common deficiencies in CTD submission dossier
Lecture 62Certificate of Analysis
Section 7Effective Management of Stability Studies of Formulation
Lecture 63Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 64Climatic Zone and Stability Study Conditions as per ICH Guidelines 
Lecture 65Stability Zone Finder
Lecture 66Stability Studies Case Discussions
Lecture 67Case Study: Managing Stability Study for Zone IV countries
Lecture 68Accelerated and intermediate testing conditions
Lecture 69Long Term Stability Testing Requirements
Lecture 70Testing Frequency
Lecture 71Bracketing
Lecture 72Matrixing
Section 8Drug Master File and Site Master File
Lecture 73Key Consideration for Drug Master File Preparation and Submission 
Lecture 74Practical Understanding on Drug Master File Preparation and Submission
Lecture 75Associated Learning: Site Master File - Detailed Understanding 
Lecture 76DMF Completeness Assessment
Lecture 77Drug Master File - Fees
Lecture 78Drug Master File - Global Perspective [Across Different Regions]
Section 9Plant Inspection Management
Lecture 79Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 80Data Integrity issues in Pharmaceutical Industry : Detailed Understanding 
Lecture 81Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 82RTQs | Response to Queries | How to handle Regulatory Queries  
Section 10QA Documentation
Lecture 83Download Entire Plant Management Documents - SOPs and Other important documents [Open formats]
Lecture 84Pharmaceutical SOPs Management from regulatory perspective
Section 11Variation Management
Lecture 85Introduction to Variation Management | Reasons for Variation | How to manage variation
Lecture 86Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 12Cost Management - How to manage the production cost
Section 13Strategic Management | Licensing | Technology Transfer
Lecture 88Patents Vs. exclusivity 
Lecture 89Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 90Orphan Drug Designation 
Lecture 91Evergreening - Patent Life Extension Strategies
Lecture 92Compulsory Licensing
Lecture 93Licensing & Technology Transfer
Lecture 94In-Licensing Vs. Outlicensing
Lecture 95LOE Strategies for Innovator Brands with case study
Lecture 96Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 97Drug Repurposing
Lecture 98Advance understanding of the portfolio Management 
Lecture 99New Indication Approval Process and Promotion 
Lecture 100OTC Switch 
Section 14Preformulation from Production Management Perspective
Lecture 101Preformulation Study in Drug Development 
Lecture 102Regulatory Requirements for Preformulation Study 
Lecture 103Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies  
Section 15Mastering ICH Guidelines
Lecture 104Introduction to ICH | Members | Guidelines 
Lecture 105ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 106ICH Q2 : Analytical Validation 
Lecture 107ICH Q3 : Impurities
Lecture 108Rest of ICH Q Family Guidelines
Section 16Managing Preclinical, Clinical Study
Lecture 109Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies 
Lecture 110Types and Timing of Non-clinical Studies 
Lecture 111Understanding on Clinical Trials  and Clinical Research 
Lecture 112Clinical Trial Protocol Writing
Lecture 113Ethics in Clinical Research
Lecture 114Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 115FDA Forms and How to fill the resources
Lecture 116PreIND, EOP1, EOP2 - What to expect !
Section 17Advanced understanding on PKPD and BABE Study
Lecture 117PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 118Bioequivalence Study | Study design | Different types of BE Studies
Lecture 119Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 120Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 121Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 122Bioequivalence Study - Discussion - Dissolution Testing
Lecture 123Bioequivalence Study - Generic Approval and Additives Labeling Requirements