Training Course: Good Manufacturing Practices (GMP) for Products & Hardware

Are you in need of tips on how to make GMP training fun and interesting? Site-visit?

REF: OC32114

DATES: 27 Jun - 8 Jul 2022

CITY: Marbella (Spain)

FEE: 7000 €

All Dates & Locations

Introduction

A Good Manufacturing Practice (GMP) system ensures that manufacturing hardware & products are consistently produced and controlled according to set quality standards. Every aspect of the manufacturing process is examined and covered by GMP to guard against any risks that can be catastrophic for products, such as cross-contamination, adulteration, and mislabeling. Implementing GMP can help cut down on losses and waste, and protects both the company and consumer from negative food safety events.
This highly educational and engaging Good Manufacturing Practice course covers the key requirements of GMP and how these are applied in the workplace. Do you need to learn about GMP and how it is applied in a manufacturing operation?  Are you in a new Supervisory/ Management role and need a detailed explanation of GMP, its requirements, and how it works? Are you involved in GMP training and in need of tips on how to make GMP training fun and interesting?
 

For group registration, this course will include a site-visit to a producing company in the same area of the participants' organization

 

Course Objectives of Good Manufacturing Practices (GMP) for Products & Hardware

  • Discover main GMP requirements for purchasing, goods-in, the warehouse, production, packaging, Quality Control, and batch release
  • Explore the main elements of the Quality Management System needed to provided the highest quality, including the requirements for documentation, training, and system monitoring and review.
  • Be able to understand the basics of Good Manufacturing Practice for products & hardware
  • Have the confidence to outline the main GMP requirements related to premises, storage facilities, and personnel
  • Get familiar with the principles of the GMP quality system and quality control and the important procedures when dealing with complaints and recalls

 

Course Outlines of Good Manufacturing Practices (GMP) for Products & Hardware

Day 1

An introduction to GMP

  • The history of GMP
  • Why do we have GMP in products like hardware?
  • GMP in the Product Lifecycle
  • The legal status of GMP
  • Current and future issues in GMP
  • Duties of key personnel and departments
  • The principle GMP requirements for documentation and records
  • GMP in the workplace
  • GMP and documentation
  • Data integrity
  • Dealing with problems and root-cause analysis
  • The reasons for GMP and GMP in facility design
  • Why do we have GMP?

Day 2

GMP – rules and guidelines

  • European Union (EU) GMP and the EU Guide to GMP
  • GMP in the United States
  • Other GMPs from around the world

Premises and facility design

  • Suitable premises and facility design
  • Heating, Ventilation and Air-Conditioning systems
  • Access, security, and pest control

Day 3

Equipment, maintenance, and calibration

  • Selection of equipment and installation
  • Planned Preventive Maintenance (PPM)
  • Calibration of measuring equipment

Validation, qualification, and change control

  • The differences between validation and qualification
  • The different stages of validation
  • The importance of controlling changes

Day 4

GMP in practice – incoming materials to product release

  • Purchasing, incoming materials, suppliers, and outsourced activities
  • GMP requirements for incoming materials
  • Supplier selection and control
  • Control of outsourced activities

The warehouse

  • Control of incoming materials
  • Storage of materials
  • Issue of materials to production
  • Control of rejected and returned materials

Day 5

Manufacturing

  • Different types of dosage forms
  • Initial checks of the area, equipment, and materials
  • Documentation and records
  • Reporting of problems

Packaging

  • Packaging equipment design and facility layout
  • Control of materials and product
  • Overprinting of artwork

Day 6

GMP and the Quality Management System

People and training

  • Organisation charts, job descriptions, and training records
  • GMP, hygiene, and job-specific training
  • Training design and evaluation

Key personnel in GMP

  • The Heads of Production, QC, and Qualified Person
  • The role of Quality and Quality Assurance
  • The importance of Senior Management

Day 7

Documentation, records, and data integrity

  • Control and approval of documents and records
  • Data Integrity and regulatory concerns
  • The use of computer systems

Day 8

Quality Risk Management

  • The need to make decisions based on risk
  • ICH Q9 and its requirements
  • Reactive and proactive risk assessments

Day 9

Deviations, incidents, and complaints

  • CAPA systems – good and bad points
  • Problem-solving and root-cause analysis
  • Dealing with complaints effectively

Day 10

Specific GMP requirements for certain types of products/hardware

  • Sterile products manufacturing
  • Biological products
  • Advanced Therapy Medicinal Products

The Quality Management System

  • Batch review and release
  • Product Quality Review
  • Internal auditing
  • Management review
  • Continual improvement

Training Course: Good Manufacturing Practices (GMP) for Products & Hardware

Are you in need of tips on how to make GMP training fun and interesting? Site-visit?

REF: OC32114

DATES: 27 Jun - 8 Jul 2022

CITY: Marbella (Spain)

FEE: 7000 €

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