Introduction to GxP Training

Live Online & Classroom Enterprise Training

Understand the fundamentals of GxP — the collection of quality guidelines and regulations that ensure products are safe, effective, and meet industry compliance standards.

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What is Introduction to GxP Training about?

GxP, short for “Good Practice,” encompasses a set of quality and regulatory standards such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP). This course introduces learners to the principles, scope, and importance of GxP in regulated industries like pharmaceuticals, biotechnology, and medical devices. Participants will learn how GxP ensures product integrity, patient safety, and compliance with global regulations. The course provides foundational knowledge for professionals working in or aspiring to enter regulated environments.

What are the objectives of Introduction to GxP Training ?

Understand the meaning, scope, and importance of GxP regulations.
Identify key components of GMP, GLP, and GCP frameworks.
Learn how GxP ensures product quality, safety, and regulatory compliance.
Recognize global regulatory bodies and their GxP expectations.
Apply GxP principles to maintain compliance in operational processes.

Who is Introduction to GxP Training for?

Quality Assurance and Regulatory Affairs Professionals.
Clinical Research Associates and Laboratory Technicians.
Manufacturing and Production Personnel.
Compliance Officers in pharmaceutical and biotech industries.
Students and professionals entering life sciences or regulated fields.

What are the prerequisites for Introduction to GxP Training?

Prerequisites:

Basic understanding of life sciences or healthcare operations.
Awareness of product quality and safety concepts.
Interest in regulatory and compliance frameworks.
No prior GxP experience required.
Willingness to learn industry-specific standards and practices.

Learning Path:

Introduction to GxP and Regulatory Importance
Overview of GMP, GLP, and GCP Guidelines
Global Regulatory Authorities and Compliance Requirements
Implementing GxP in Operations and Documentation Practices
Audits, Inspections, and Continuous Quality Improvement

Related Courses:

Good Manufacturing Practice (GMP) Fundamentals
Good Laboratory Practice (GLP) Compliance
Regulatory Affairs and Quality Management
Pharmaceutical Quality Systems and Validation

Available Training Modes

Live Online Training

1 Days

Course Outline Expand All

Expand All

Module 1: Introduction to GxP Guidelines

Definition and Purpose of GxP

Importance of Compliance in Regulated Industries

Key Regulatory Bodies (FDA, EMA, WHO)

Evolution and Globalization of GxP Standards

Benefits of Implementing GxP Frameworks

Module 2: The Many Faces of GxP

Overview of Different “Good Practices”

Relationship Between GMP, GLP, GCP, GDP, and GDocP

Cross-Functional Application in the Product Lifecycle

Common Principles Across All GxP Areas

Case Studies: Integrating GxP Systems

Module 3: Good Manufacturing Practice (GMP)

Core Principles and Objectives of GMP

Facility and Equipment Requirements

Production Controls and Quality Assurance

Documentation and Record Keeping in GMP

Regulatory Audits and Inspections

Module 4: Good Laboratory Practice (GLP)

Purpose and Scope of GLP

Laboratory Organization and Personnel Responsibilities

Standard Operating Procedures (SOPs)

Data Integrity and Archiving Practices

GLP Auditing and Compliance Verification

Module 5: Good Distribution Practice (GDP)

Principles of GDP and Supply Chain Integrity

Storage, Handling, and Transportation Requirements

Role of Documentation in GDP Compliance

Risk Management in Distribution Processes

GDP Audits and Corrective Actions

Module 6: Good Clinical Practice (GCP)

Overview and Importance of GCP

Roles and Responsibilities of Investigators and Sponsors

Informed Consent and Ethics Committees

Clinical Trial Documentation and Monitoring

Data Handling and Safety Reporting

Module 7: Good Documentation Practice (GDocP)

Principles of ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate)

Document Control and Version Management

Electronic Records and Signatures (ERES Compliance)

Audit Trails and Traceability

Common Errors and Best Documentation Practices

Who is the instructor for this training?

The trainer for this Introduction to GxP Training has extensive experience in this domain, including years of experience training & mentoring professionals.

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