Training on NAFDAC Regulations and Compliance

Overview: Pertecnica Engineering is pleased to offer a specialized training program focused on NAFDAC (National Agency for Food and Drug Administration and Control) regulations and compliance. This comprehensive course is designed to provide participants with the knowledge and skills necessary to navigate the regulatory landscape of the Nigerian pharmaceutical and food industries. Participants will gain insights into NAFDAC’s regulatory requirements, quality standards, and compliance procedures, ensuring they are well-equipped to meet regulatory obligations and maintain product quality and safety.

Why Choose Pertecnica Engineering?

  • Industry-Relevant Curriculum: Developed in collaboration with regulatory experts and industry professionals, ensuring the training is current and practical.
  • Experienced Instructors: Learn from seasoned professionals with extensive experience in NAFDAC regulations and compliance.
  • Hands-On Training: Gain practical experience through case studies, workshops, and interactive sessions.
  • Tailored Solutions: Customized training modules to meet the specific needs of participants and organizations.
  • Career Support: Benefit from our placement assistance and career guidance to advance your career in regulatory affairs.

Course Syllabus:

  1. Introduction to NAFDAC
    • Overview of NAFDAC’s Role and Responsibilities
    • Regulatory Framework and Legislation
    • Importance of NAFDAC Compliance in the Pharmaceutical and Food Industries
  2. NAFDAC Regulations for Pharmaceuticals
    • Registration Procedures for Medicines and Health Products
    • Good Manufacturing Practices (GMP) Guidelines
    • Pharmacovigilance and Post-Market Surveillance
  3. NAFDAC Regulations for Food Products
    • Food Product Registration and Labeling Requirements
    • Food Safety and Hygiene Standards
    • Import and Export Regulations for Food Products
  4. Quality Management Systems (QMS) for NAFDAC Compliance
    • Implementing QMS in Pharmaceutical and Food Manufacturing
    • Documentation and Record-Keeping Practices
    • Internal Audits and Inspections
  5. Good Laboratory Practices (GLP) and Analytical Testing
    • GLP Requirements for Laboratory Operations
    • Analytical Testing Methods and Validation
    • Ensuring Accuracy and Reliability of Test Results
  6. Regulatory Reporting and Documentation
    • Preparation of Regulatory Submissions and Dossiers
    • Document Control and Versioning
    • Regulatory Reporting Obligations and Timelines
  7. NAFDAC Inspections and Audits
    • Understanding NAFDAC Inspection Procedures
    • Preparation for NAFDAC Audits
    • Responding to Inspection Findings and Corrective Actions
  8. Case Studies and Practical Applications
    • Real-Life Case Studies of NAFDAC Compliance Challenges and Solutions
    • Workshop Sessions to Apply NAFDAC Regulations to Practical Scenarios
    • Best Practices and Lessons Learned from Industry Experiences

Course Modules in Detail:

Module 1: Introduction to NAFDAC

  • Understanding the role and mandate of NAFDAC in regulating pharmaceuticals and food products.
  • Familiarizing with the regulatory framework, including relevant laws and regulations governing the industry.
  • Recognizing the importance of NAFDAC compliance for product safety, efficacy, and public health.

Module 2: NAFDAC Regulations for Pharmaceuticals

  • Navigating the registration process for medicines and health products with NAFDAC.
  • Implementing Good Manufacturing Practices (GMP) to ensure product quality and safety.
  • Understanding pharmacovigilance requirements for monitoring and reporting adverse drug reactions.

Module 3: NAFDAC Regulations for Food Products

  • Complying with registration and labeling requirements for food products in Nigeria.
  • Adhering to food safety and hygiene standards set by NAFDAC.
  • Understanding import and export regulations for food products to and from Nigeria.

Module 4: Quality Management Systems (QMS) for NAFDAC Compliance

  • Establishing and maintaining Quality Management Systems in pharmaceutical and food manufacturing.
  • Documenting procedures and maintaining records to demonstrate compliance with NAFDAC regulations.
  • Conducting internal audits to identify areas for improvement and ensure regulatory compliance.

Module 5: Good Laboratory Practices (GLP) and Analytical Testing

  • Implementing GLP requirements for laboratory operations, including equipment calibration and maintenance.
  • Validating analytical testing methods to ensure accuracy, precision, and reliability.
  • Ensuring compliance with NAFDAC requirements for laboratory testing and data integrity.

Module 6: Regulatory Reporting and Documentation

  • Preparing regulatory submissions and dossiers for product registration with NAFDAC.
  • Managing document control and versioning to ensure the accuracy and completeness of regulatory documentation.
  • Meeting regulatory reporting obligations and timelines for adverse events, product recalls, and other incidents.

Module 7: NAFDAC Inspections and Audits

  • Understanding the process and criteria for NAFDAC inspections of manufacturing facilities and laboratories.
  • Preparing for NAFDAC audits by ensuring compliance with applicable regulations and guidelines.
  • Responding effectively to inspection findings and implementing corrective actions to address deficiencies.

Module 8: Case Studies and Practical Applications

  • Analyzing real-life case studies of NAFDAC compliance challenges faced by pharmaceutical and food companies.
  • Participating in workshop sessions to apply NAFDAC regulations to practical scenarios and develop compliance strategies.
  • Learning from industry experiences and best practices to enhance regulatory compliance efforts.

Training Methodology: Our training methodology emphasizes interactive learning and practical application, including:

  • Lectures and Presentations: Engaging sessions covering key concepts and regulatory requirements by experienced instructors.
  • Case Studies: Real-life case studies to illustrate NAFDAC compliance challenges and solutions.
  • Workshop Sessions: Interactive workshops to apply NAFDAC regulations to practical scenarios and develop compliance strategies.
  • Group Discussions: Opportunities for participants to share experiences, ask questions, and exchange insights with peers.