ANVISA (Agência Nacional de Vigilância Sanitária) Compliance Training
Course Overview:
Pertecnica Engineering offers a specialized corporate training program: ANVISA Compliance Training. This course is designed to provide professionals with in-depth knowledge and practical skills required to navigate the regulatory landscape set by ANVISA, Brazil’s National Health Surveillance Agency. Participants will learn about ANVISA’s regulations, guidelines, and compliance requirements for pharmaceutical products, medical devices, cosmetics, and food. This comprehensive training prepares participants for roles in regulatory affairs, quality assurance, and compliance management, equipping them with the tools needed to ensure that products meet ANVISA’s stringent standards.
Course Objectives:
- Understand the role and functions of ANVISA in regulating health products.
- Gain detailed knowledge of ANVISA regulations and compliance requirements.
- Develop skills to prepare and submit product registrations, renewals, and variations.
- Learn about Good Manufacturing Practices (GMP) and quality assurance in the context of ANVISA compliance.
- Equip participants with the ability to manage audits, inspections, and regulatory submissions effectively.
Course Syllabus:
Module 1: Introduction to ANVISA and Regulatory Environment
- Overview of ANVISA’s role and responsibilities
- Regulatory frameworks and guidelines enforced by ANVISA
- Key legislation and regulatory updates
Module 2: ANVISA Regulations and Guidelines
- Understanding the Brazilian Health Regulatory System
- ANVISA’s guidelines for pharmaceuticals, medical devices, cosmetics, and food
- Classification and categorization of health products
Module 3: Product Registration and Submission Process
- Steps for product registration with ANVISA
- Submission requirements and necessary documentation
- Electronic submission processes (SISCOMEX, electronic visa systems)
Module 4: Good Manufacturing Practices (GMP)
- GMP principles and their importance in the pharmaceutical industry
- ANVISA’s GMP requirements and guidelines
- Conducting GMP audits and inspections in compliance with ANVISA standards
Module 5: Quality Assurance and Control
- Quality management systems (QMS) and their implementation
- Quality control procedures and best practices
- Handling deviations, non-conformances, and CAPA (Corrective and Preventive Actions)
Module 6: Post-Market Surveillance and Pharmacovigilance
- ANVISA’s requirements for post-market surveillance
- Adverse event reporting and risk management
- Conducting pharmacovigilance activities and compliance reporting
Module 7: Regulatory Compliance for Medical Devices
- Specific ANVISA regulations for medical devices
- Device classification, conformity assessment, and certification
- Labeling, advertising, and marketing requirements for medical devices
Module 8: Regulatory Compliance for Cosmetics and Food
- ANVISA regulations for cosmetics and personal care products
- Food safety regulations and compliance requirements
- Approval process and safety monitoring for cosmetics and food products
Module 9: Managing ANVISA Audits and Inspections
- Preparing for ANVISA audits and inspections
- Conducting internal audits and mock inspections
- Responding to audit findings and implementing corrective actions
Module 10: Practical Workshops and Case Studies
- Hands-on training in preparing ANVISA submissions
- Case studies of successful and unsuccessful ANVISA compliance strategies
- Role-playing scenarios for audit and inspection preparedness
Learning Outcomes:
Upon completing this course, participants will be able to:
- Navigate ANVISA regulations and guidelines with confidence.
- Prepare and submit thorough and compliant product registrations and variations.
- Implement and maintain GMP and quality assurance systems that meet ANVISA standards.
- Manage audits, inspections, and regulatory submissions effectively.
- Ensure ongoing compliance with ANVISA requirements for pharmaceuticals, medical devices, cosmetics, and food.
Target Audience:
This course is ideal for regulatory affairs professionals, quality assurance managers, compliance officers, production managers, and other professionals involved in the pharmaceutical, medical device, cosmetics, and food sectors seeking to enhance their understanding of ANVISA regulations and compliance.
Course Duration:
The course spans over 12 weeks, combining theoretical lessons, practical workshops, hands-on training, and real-world case studies.
Certification:
Participants will receive a Certification in ANVISA Compliance Training upon successful completion of the course, validating their proficiency in ANVISA regulations, GMP, quality assurance, and regulatory compliance.
Enrollment:
Interested candidates can enroll in the ANVISA Compliance Training course by visiting our website or contacting our admissions office.
Join Pertecnica Engineering and advance your career in the health product sector with our ANVISA Compliance Training, equipping yourself with the skills and knowledge to ensure regulatory compliance and maintain the highest standards of product safety and quality in Brazil