Training Introduction:

In the pharmaceutical, food, and healthcare industries, Good Manufacturing Practices (GMP) demand a structured approach to identify hazards, assess risks, and implement corrective and preventive actions (CAPA). An effective hazard analysis and risk management system not only ensures product quality and patient safety but also protects companies from regulatory non-compliance.

This training program provides participants with a practical framework to evaluate risks, apply hazard analysis techniques, and establish robust CAPA systems aligned with GMP requirements.

Training Objectives:

By the end of the training, participants will be able to:

·        Understand hazard analysis concepts in GMP environments.

·        Apply risk management tools and methodologies.

·        Link hazard and risk assessment to product quality and safety.

·        Develop effective CAPA systems for continuous improvement.

·        Ensure compliance with regulatory standards (FDA, EMA, WHO, ISO).

Learning Outcomes:

After completing the training, participants will be able to:

·       Identify and analyze potential hazards in GMP operations.

·       Apply risk management tools to evaluate and prioritize risks.

·       Develop and implement effective CAPA systems.

·       Ensure regulatory compliance through hazard and risk documentation.

·       Strengthen continuous improvement culture by integrating hazard analysis, risk management, and CAPA.

Target Audience:

·        Quality Assurance (QA) & Quality Control (QC) Teams

·        Production & Operations Staff

·        Regulatory Affairs Professionals

·        Risk & Compliance Managers

·        GMP Auditors and Inspectors

Training Methods:

·        Interactive lectures & multimedia presentations

·        Case studies from GMP-regulated industries

·        Hands-on risk assessment exercises

·        Group discussions & problem-solving activities

·        Quizzes and feedback sessions

Training Content / Modules:

Module 1: Hazard Analysis under GMP

·        Types of hazards: physical, chemical, biological, procedural

·        Hazard identification methods (FMEA, HACCP principles)

·        Case examples of GMP hazards

Module 2: Risk Management Principles

·        Risk assessment tools: Risk Matrix, FMEA, HAZOP

·        Probability, severity & detectability of risks

·        Documentation & traceability of risk management

Module 3: CAPA in GMP

·        Introduction to CAPA and its importance

·        Corrective actions vs. preventive actions

·        Root Cause Analysis (RCA) techniques

·        CAPA documentation & regulatory expectations

Module 4: Integrated Hazard-Risk-CAPA System

·        Linking hazard analysis to risk evaluation

·        CAPA as a risk mitigation tool

·        Examples of CAPA in real GMP inspections

Module 5: Case Studies & Practical Exercise

·        Risk assessment workshop

·        CAPA implementation simulation

·        Review of industry best practices

Course Summary:

·       Online Virtual & In Personal Classroom Training

·       04 Modules & 08 Sessions (Online Training)

·       Day Long (9:00 AM-5:00 PM)-8 Hours for Classroom Training

·       Google Meet Link’s Training (For Online)

·       Certificate Course & Certificate shall be awarded

·       04 Soft PDF Training Module shall provide

Registration Hotlines:

01739-138399

01312-138399

01824-576598

01772-825678

WhatsApp Number:

01739-138399

01312-138399

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Registration Fee:

Online Mode:

BDT 3500/- Per Person

In person Classroom Training:

BDT 4000/- Per Person

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Payment Modes:

Bkash A/C: 01739-138399 (Personal)

Nagad A/C: 01739-138399 (Personal)

DBBL Rocket A/C: 01739-1383997 (Personal)

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DBBL Nexus Pay-01:

Card Number:0121 0845 8527

A/C Name: Mohammad Abdur Rahman

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Bank Account Number

A/C NAME: MOHAMMAD ABDUR RAHMAN

A/C NUMBER: 3001570018186

ROUTING NUMBER: 090262087

BRANCH: IBRAHIMPUR BANK: DUTCH-BANGLA BANK LTD.

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Email: compliancetrainingbd2019@gmail.com

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