Training Introduction:

In today’s regulated industries, maintaining high standards of quality and safety is essential. Proper documentation, complete traceability, and robust data integrity form the backbone of reliable operations in manufacturing, laboratories, and service processes.

This training provides participants with a clear understanding of how to maintain accurate documentation, ensure traceability of materials and products, and uphold data integrity principles in compliance with regulatory and quality standards. Interactive sessions, real-world examples, and practical exercises ensure hands-on learning and effective application in daily operations.

Training Objectives:

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

§  Understand the importance of accurate documentation and good documentation practices (GDP).

§  Learn methods to ensure traceability of materials, products, and processes.

§  Understand and implement data integrity principles (ALCOA+).

§  Recognize the link between documentation, traceability, data integrity, and quality & safety systems.

§  Identify common errors and non-compliances and apply corrective measures.

Learning Outcomes:

After completing the training, participants will be able to:

·        Maintain accurate and compliant documentation.

·        Ensure complete traceability of products, materials, and processes.

·        Uphold data integrity in their daily operations.

·        Identify and correct errors to support quality and regulatory compliance.

Target Audience:

·        Quality Assurance (QA) Staff

·        Production & Laboratory Personnel

·        Regulatory Compliance Teams

·        Data Handling Staff

·        Any employee involved in documentation, reporting, or quality processes

Training Methods:

·        Interactive classroom lectures or online sessions

·        Real-life case studies & examples

·        Practical exercises & group activities

·        Quizzes & assessments to reinforce learning

·        Discussion & Q&A sessions

Training Content / Modules:

Module 1: Introduction to Documentation

·        Importance of documentation in quality & safety

·        Types of documentation (SOPs, batch records, logbooks)

·        Good Documentation Practices (GDP)

·        Common documentation errors and consequences

Module 2: Traceability

·        Definition and importance

·        Methods: batch numbers, equipment IDs, product lifecycle tracking

·        Role in audits and regulatory compliance

·        Practical exercises on traceable record creation

Module 3: Data Integrity

·        Definition and significance

·        Principles: ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available)

·        Common data integrity issues and red flags

·        Data review and verification techniques

Module 4: Integration with Quality & Safety Systems

·        Linking documentation, traceability, and data integrity to ISO, GMP, and other standards

·        Handling incidents and corrective actions

Module 5: Practical Exercises & Case Studies

·        Hands-on review of records

·        Identifying gaps in traceability

·        Correcting documentation errors

Module 6: Key Takeaways & Assessment

·        Recap of best practices

·        Quiz / assessment

·        Certificates of completion (optional)

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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