Training Introduction:

In a GMP-regulated environment, equipment safety, calibration, and validation play a crucial role in ensuring product quality, regulatory compliance, and worker safety. Properly maintained and validated equipment minimizes risks of contamination, deviations, and operational failures.

This training provides participants with comprehensive knowledge on equipment safety protocols, calibration techniques, and validation procedures as required by GMP standards. Through real case studies and practical examples, participants will learn how to maintain equipment reliability and compliance.

Training Objectives:

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

·        Understand the importance of equipment safety in GMP environments.

·        Learn calibration requirements and documentation practices.

·        Gain knowledge of validation types (IQ, OQ, PQ).

·        Apply regulatory guidelines for calibration and validation.

·        Develop corrective and preventive measures to ensure equipment compliance.

Learning Outcomes:

After completing the training, participants will be able to:

·       Implement equipment safety measures in GMP operations.

·       Ensure proper calibration and maintain accurate records.

·       Conduct and oversee validation processes (IQ, OQ, PQ).

·       Apply GMP guidelines for equipment compliance.

·       Develop CAPA strategies to address equipment safety, calibration, and validation issues.

Target Audience:

·        Production & Maintenance Personnel

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

·        Engineering & Technical Staff

·        Validation Specialists

·        Regulatory Compliance Officers

Training Methods:

·        Interactive presentations & lectures

·        Case studies & real-life GMP compliance issues

·        Hands-on exercises / demonstrations

·        Group discussions & Q&A sessions

·        Quizzes & assessment activities

Training Content / Modules:

Module 1: Equipment Safety under GMP

·        Equipment safety standards & regulatory guidelines

·        Safe operation and maintenance practices

·        Risk management and hazard prevention

Module 2: Calibration Fundamentals

·        Importance of calibration in GMP compliance

·        Calibration frequency and schedules

·        Documentation & traceability requirements

·        Handling calibration deviations

Module 3: Validation in GMP

·        Introduction to validation (Process, Cleaning, Equipment)

·        Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)

·        Validation protocols and reporting

Module 4: Practical Aspects & Case Studies

·        Examples of equipment failures due to poor calibration/validation

·        Best practices for maintaining equipment reliability

·        Corrective & preventive actions (CAPA)

Module 5: Key Takeaways & Assessment

·        Recap of safety, calibration & validation practices

·        Short quiz/assessment

·        Certification of completion (if applicable)

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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