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Academy Pharmaceutical Excellence

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Quality Assurance Entry Level Training Program

Quality Assurance Entry Level Training Program

Highlights

  • Delivered Online

  • 12 months

  • All levels

Description

This course is designed to equip participants with comprehensive knowledge in Pharmaceutical Quality System and Good Manufacturing and Distribution Practices. It covers the entire lifecycle of pharmaceutical production, from initial design and development to distribution and compliance.

The course includes real-world case studies and interactive tools. Course Objectives

Career Launch: Equip those with little or no GMP/QA experience with the essential knowledge, practical skills, and industry support needed to launch a successful career.

Comprehensive Foundation: Provide a strong foundational understanding of QA in the EU, UK, and US, preparing you for diverse opportunities in the global market

Frequently Asked Questions

  • Are there any entry requirements?

    Academic Background: Currently studying for or holding a degree in science or engineering (or an equivalent qualification)


    Career Aspirations: A passion for entering or advancing their knowledge in the Quality field with a commitment to mastering the basics and beyond

  • Who should attend?

    Entry-level GMP and Quality Assurance professionals, production managers, regulatory affairs staff, GMP auditors, and validation engineers

course Content

12 sections•151 lessons
Introduction of GMDP Regulations and Importance to GMDP14 lessons
  1. 1Overview of GMDP Regulations (Medicines Law) & Importance of GMDP
  2. 2 Introduction to GxP
  3. 3 Human Medicines Regulation 2012
  4. 4 EU laws and regulations
  5. 5 GMP Structure & The Orange Guide
  6. 6 Regulatory Agencies in Pharmaceutical Manufacturing
  7. 7Veterinary Medicines Legislation
  8. 8PIC/S –Pharmaceutical Inspection Convention and Co-Operation Scheme
  9. 9International Conference on Harmonisation of Technical Requirements
  10. 10Grant and Supervision of Licences
  11. 11What are the Pharmacopoeias
  12. 12 GMP vs ISO
  13. 13Control of Product Lifecycles
  14. 14Controlled Drugs
Module - 2 Chapter - 1: Pharmaceutical Quality System (PQS10 lessons
  1. 1Session 1 - Introduction to the Pharmaceutical Quality System (PQS)
  2. 2 Session 2 - Key Components of Quality Management
  3. 3 Session 3 - Designing and Implementing a Robust Pharmaceutical Quality System
  4. 4Session 4 - Roles and Responsibilities in PQS management
  5. 5 Session 5 - Product Realization and Lifecycle Management
  6. 6Session 6 - Change Management System
  7. 7Session 7 - Errors, Deviation and CAPA Management System
  8. 8Session 8 - Quality Risk Management (QRM) & Knowledge Management
  9. 9Session 9 - Continuous Improvement Strategies
  10. 10Session 10 - Ongoing Monitoring and Senior Management Review
Module 3 Chapter - 2: Personnel11 lessons
  1. 1Session 1 - Importance of Personnel in GMP
  2. 2 Session 2 - Organisational Structure and Responsibilities
  3. 3 Session 3 - Key Management Personnel Roles
  4. 4 Session 4 - Shared Responsibilities in Quality Management
  5. 5 Session 5 - Training Programs for Personnel
  6. 6 Session 6 - Personnel Hygiene and Health
  7. 7Session 7 - GMP Practices Related to Personnel
  8. 8Session 8 - Consultant Management
  9. 9Session 9 - Senior Management Responsibilities in Personnel Management
  10. 10 Session 10 - Managing Visitors and Untrained Personne
  11. 11Session 11 - Practical Application: Scenario-Based Training
Module - 4 Chapter - 3: Premises and Equipments12 lessons
  1. 1 Session 1 - General Requirements for Premises
  2. 2 Session 2 - Production Area Design and Management
  3. 3 Session 3 - Storage Area Requirements
  4. 4 Session 4 - Quality Control Area Design
  5. 5Session 5 - Ancillary Areas Management
  6. 6 Session 6 - Cross-Contamination Prevention Strategies
  7. 7 Session 7 - General Requirements for Equipmen
  8. 8Session 8 - Equipment Cleaning and Maintenance
  9. 9 Session 9 - Validation, Qualification, Calibration and Verification of Equipment
  10. 10 Session 10 - Management of Fixed Pipework and Water System
  11. 11 Session 11 - Equipment Risk Management
  12. 12 Session 12 - Documentation and Record-Keeping
Module - 5 Chapter - 4: Documentation12 lessons
  1. 1 Session 1 - Required GMP Documentation
  2. 2 Session 2 - Generation and Control of Documentation
  3. 3Session 3 - Retention of Documents
  4. 4 Session 4 - Good Documentation Practices
  5. 5 Session 5 - Standard Operating Procedures (SOPs)
  6. 6 Session 6 - Manufacturing Formula and Processing Instructions
  7. 7Session 7 - Specifications
  8. 8Session 8 - Batch Processing Record
  9. 9 Session 9 - Batch Packaging Record
  10. 10 Session 10 - Logbooks and Operating Procedures
  11. 11 Session 11 - Managing PQS for GMP Documentation
  12. 12Session 12 - Data Integrity
Module - 6 Chapter - 5: Production13 lessons
  1. 1 Session 1 - Identifying Production Steps
  2. 2 Session 2 - Setting Specifications and Bio-Batch Activities
  3. 3 Session 3 - Handling Materials and Products
  4. 4Session 4 - Labelling and Documentation in Production
  5. 5 Session 5 - Yield and reconciliation
  6. 6 Session 6 - Prevention of Cross-Contamination- Gowning, Sanitization and hygiene, Environmental monitoring and control, Cleaning Validation
  7. 7 Session 7 - Validation in Production
  8. 8 Session 8 - Good Engineering Practices
  9. 9Session 9 - Packaging Operations
  10. 10 Session 11 - Warehouse Operations
  11. 11 Session 12 - Handling Rejected, Recovered, and Returned Materials
  12. 12 Session 13 - Finished Products and Product Shortage Management
  13. 13Session 10 - Printed material control
Module - 7 Chapter - 6: Quality Control14 lessons
  1. 1 Session 1 - Overview of Quality Control in GMP
  2. 2 Session 2 - Good Quality Control Laboratory Practices
  3. 3 Session 3 - Laboratory Design Audit
  4. 4 Session 4 - Documentation and Data Integrity in QC
  5. 5Session 5 - Sampling Techniques and Best Practices
  6. 6Session 6 - Testing and Validation in QC
  7. 7 Session 7 - Analytical Methods Development
  8. 8Session 8 - Method validation
  9. 9Session 9 - Method Transfer
  10. 10Session 10 - Managing OOS/OOT Results
  11. 11Session 11 - Stability Studies and Shelf-Life Evaluation
  12. 12 Session 12 - Technical Transfer of Testing Methods
  13. 13 Session 13 - QC in a GMP Environment: Challenges and Best Practices
  14. 14 Session 14 - QC testing learning platforms
Module - 8 Chapter - 7: Outsource Activities13 lessons
  1. 1Session 1 - Introduction to Outsourced Activities and Contract Giver Responsibilities
  2. 2 Session 2 - Responsibilities of the Contract Giver
  3. 3 Session 3 - Responsibilities of the Contract Acceptor
  4. 4 Session 4 - The Contract: Content and Structure
  5. 5 Session 5 - Quality Management in Outsourced Activities
  6. 6 Session 6 - Quality Risk Management
  7. 7Session 7 - Managing Challenges in Outsourced Activities
  8. 8 Session 8 - Technical Quality Agreements
  9. 9 Session 9 - Service Level Agreements
  10. 10Session 10 - Technical Agreements with QP
  11. 11 Session 11 - When to raise Change Control
  12. 12Session 12 - API Sourcing
  13. 13Session 13 - Supplier Qualification
Module - 9 Chapter 8 - Complaints, Quality Defects, and Product Recalls12 lessons
  1. 1 Session 1 - Overview of Complaint Handling and Quality Defects
  2. 2 Session 2 - Responsibilities and Organisation in Complaint and Quality Defect Management
  3. 3 Session 3 - Investigating Quality Defects and Implementing CAPAs
  4. 4 Session 4 - Conducting a Quality Defect Investigation
  5. 5 Session 5 - Procedures for Product Recalls
  6. 6Session 6 - Evaluating the Effectiveness of Recall Procedures
  7. 7 Session 7 - Overview of Pharmacovigilance
  8. 8Session 8 - Post-Market Surveillance
  9. 9 Session 9 - Regulatory Expectations
  10. 10Session 10 - Managing Change in Pharmacovigilance
  11. 11Session 11 - Database Management in Pharmacovigilance
  12. 12Session 12 - Ensuring Timeliness in Pharmacovigilance
Module - 10 Chapter 9 - Self-Inspection and Audit14 lessons
  1. 1Session 1 - Understanding the Self Inspection
  2. 2Session 2 - Planning and Scheduling Self Inspections
  3. 3Session 3 - Self Inspection Preparation
  4. 4Session 4 - Performing a Self Inspection
  5. 5Session 5 - Reporting and Documentation of Self Inspections
  6. 6Session 6 - Implementing Corrective Actions
  7. 7Session 7 - Continuous Improvement and Follow-up Inspections
  8. 8 Session 8 - Why Audits are carried out?
  9. 9Session 9 - Types of Audits
  10. 10Session 10 - Hosting Regulatory Inspections
  11. 11 Session 11 - Attributes and Experiences of a Good Auditor
  12. 12Session 12 - Post Audit Activities and Follow up
  13. 13Session 13 - PIC/S GMP Guide
  14. 14Session 14 - Critical Areas Often Overlooked in Audits
Module – 11 Good Distribution Practice (cGDP)13 lessons
  1. 1 Session 1 - Overview of Good Distribution Practice (cGDP) & regulations and framework
  2. 2 Session 2 - Pharmaceutical Storage and Distribution Requirements
  3. 3 Session 3 - Stores Design and Materials/Products Flow
  4. 4Session 4 - Materials Receipt, Quarantine, Release, and Storage
  5. 5 Session 5 - Environmental Monitoring and Control
  6. 6Session 6 - Transportation
  7. 7 Session 7 - Thermal Mapping and Qualification of Stores and Distribution Vehicles
  8. 8Session 8 - Pest and Rodents’ Control
  9. 9Session 9 - Products Distribution and Freight Forwarding
  10. 10 Session 10 - ERP Systems in Pharmaceutical Distribution
  11. 11Session 11 - Supplier and Customer Approval, Vendor Management
  12. 12 Session 12 - Reject Handling, Disposal, and Segregation
  13. 13Session 13 - Falsified Products
Module – 12 Regulatory Affairs & Regulatory Submissions13 lessons
  1. 1 Session 1 - Introduction to Drug Development and Regulatory Affairs
  2. 2 Session 2 - The Drug Development Lifecycle
  3. 3 Session 3 - Regulatory Frameworks and Authorities
  4. 4 Session 4 - The Role of Regulatory Affairs Professionals
  5. 5 Session 5 - Understanding Global and EU Regulatory Landscape
  6. 6 Session 6 - Medicines Legislation in the EU and UK
  7. 7 Session 7 - Thermal Mapping and Qualification of Storage Facilities and Distribution Vehicles
  8. 8Session 8 - Pest and Rodent Control in Pharmaceutical Warehouses
  9. 9 Session 9 - Products Distribution and Fre
  10. 10 Session 10 - ERP Systems and Compliance in Pharmaceutical Distribution
  11. 11Session 11 - Supplier and Customer Approval, and Vendor Management
  12. 12Session 12 - Handling Rejections, Disposal, and Segregation of Products
  13. 13 Session 13 - Prevention and Management of Falsified Products in Distribution

Dates

  • Live Webinar
      to   (31 sessions)
    50 spaces left
    Delivered Online
    £12,000+ VAT

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