Document Control Professional course equips you with procedures to set the framework for how documents are approved, updated or amended, how changes are tracked, how documents are published, and how documents are made outdated. This course aims to equip you with the skills and knowledge necessary to setup a centralized ERP system to manage every document and file governed by an established document control program, including the Document Control Procedures Manual itself. Here’s a general outline of what this course might cover:

Learning objectives
In this course, you will learn:

• Understanding of document control principles and practices.
• Managing documents, ensuring compliance with relevant regulations and standards.
• Streamline processes and minimize risks associated with document mismanagement.
• Learn about data management and integration best practices.
• Problem-solving skills related to document accuracy, accessibility, and security.

UNIT 1
    Introduction to Document Control

• Lesson 1: Overview of document control and its importance in regulatory compliance and organizational efficiency
• Lesson 2:Historical perspective and evolution of document control practices.
• Lesson 3: Role and responsibilities of a document control professional
• Introduction to relevant standards and regulations (e.g., ISO 9001, FDA regulations, etc.)

UNIT 2
    Document Lifecycle Management

• Lesson 1: Understanding the document lifecycle from creation to disposal
• Lesson 2: Document types and their characteristics (e.g., policies, procedures, specifications, drawings, etc.)
• Lesson 3: Document classification, categorization, and coding systems.
• Lesson 4: Revision control and version management.

UNIT 3
    Document Control Systems

• Lesson 1: Introduction to document management software and tools.
• Lesson 2: Evaluation criteria for selecting document control systems.
• Lesson 3: Implementation best practices and considerations.
• Lesson 4: Integration with other quality management systems (QMS) and enterprise systems.

UNIT 4
    Document Control Procedures

• Lesson 1: Developing document control procedures and workflows.
• Lesson 2: Document creation, review, approval, distribution, and obsolescence processes.
• Lesson 3: Change management procedures and handling deviations.
• Lesson 4: Document retention and archiving policies.

UNIT 5
    Regulatory Compliance

• Lesson 1: Understanding regulatory requirements related to document control in specific industries (e.g., pharmaceuticals, aerospace, healthcare, etc.).
• Lesson 2: Compliance with standards such as Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
• Lesson 3: Auditing and inspection readiness.

UNIT 6
    Document Security and Confidentiality

• Lesson 1: Principles of document security and confidentiality.
• Lesson 2: Access control mechanisms and user permissions.
• Lesson 3: Protection of sensitive information and intellectual property.
• Lesson 4: Data integrity and validation principles.

UNIT 7
    Quality Assurance and Continuous Improvement

• Lesson 1: Role of document control in quality assurance processes.
• Lesson 2: Monitoring and measuring document control effectiveness.
• Lesson 3: Corrective and preventive actions (CAPA) related to document management.
• Lesson 4: Continuous improvement methodologies (e.g., PDCA cycle, Six Sigma, Lean, etc.).

UNIT 8
    Compliance and Risk Management

• Lesson 1: Effective communication strategies for document control professionals.
• Lesson 2: Training programs for document creators, reviewers, and approvers.
• Lesson 3: Change management communication strategies.
• Lesson 4: Documentation of training records and competency assessments.

UNIT 9
    Final Project or Capstone

• Lesson 1: Application of knowledge and skills acquired throughout the course.
• Lesson 2: Planning and executing a mock ERP implementation project.
• Lesson 3: Presentation of findings and recommendations.

UNIT 10
    Certification Exam Preparation

• Lesson 1: Review of key concepts covered in the course.
• Lesson 2: Practice exams and quizzes.
• Lesson 3: Exam-taking strategies and tips.
• Conclusion
• Exam

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