IPQA (In-Process Quality Assurance) Training
Course Overview:
Pertecnica Engineering offers a specialized training program: In-Process Quality Assurance (IPQA) Training. This course is designed to provide participants with comprehensive knowledge and practical skills necessary to implement and manage in-process quality assurance systems within the pharmaceutical and manufacturing industries. Participants will learn about quality assurance principles, regulatory requirements, IPQA techniques, and best practices for maintaining product quality throughout the manufacturing process. This training prepares participants for roles in quality assurance, production, and regulatory compliance, and equips them with the tools needed to ensure consistent product quality.
Course Objectives:
- Understand the principles and importance of in-process quality assurance.
- Gain knowledge of regulatory requirements and compliance standards related to IPQA.
- Develop skills in monitoring and controlling quality during the manufacturing process.
- Learn to implement IPQA techniques and best practices.
- Equip participants with the knowledge to handle IPQA documentation and audits.
Course Syllabus:
Module 1: Introduction to IPQA
- Overview of in-process quality assurance
- Importance of IPQA in manufacturing and pharmaceuticals
- Roles and responsibilities of IPQA professionals
Module 2: Regulatory Requirements and Standards
- Regulatory bodies and guidelines (FDA, EMA, WHO)
- Good Manufacturing Practices (GMP) and IPQA
- Compliance with international quality standards (ISO, ICH)
Module 3: Quality Assurance Principles and Concepts
- Quality management systems (QMS)
- Principles of quality assurance and control
- Risk management and quality by design (QbD)
Module 4: IPQA Techniques and Tools
- Sampling and inspection methods
- Statistical process control (SPC)
- Control charts and process capability analysis
- Root cause analysis and corrective actions
Module 5: Monitoring and Controlling Quality
- Real-time monitoring techniques
- In-process checks and controls
- Ensuring consistency and uniformity in production
- Documentation and record-keeping
Module 6: Quality Control Laboratories
- Role of quality control labs in IPQA
- Analytical methods and instrumentation
- Laboratory data management and compliance
Module 7: Process Validation and Verification
- Understanding process validation stages
- Process qualification and performance qualification
- Continuous process verification
Module 8: Handling Deviations and Non-Conformances
- Identifying and reporting deviations
- Investigating non-conformances
- Implementing corrective and preventive actions (CAPA)
Module 9: Audits and Inspections
- Preparing for internal and external audits
- Conducting self-inspections and mock audits
- Responding to audit findings and regulatory inspections
Module 10: Practical Workshops and Real-World Applications
- Hands-on training in IPQA techniques and tools
- Simulated scenarios for monitoring and controlling quality
- Case studies and best practices in IPQA
- Collaborative learning and peer reviews
Learning Outcomes:
Upon completing this course, participants will be able to:
- Implement and manage effective IPQA systems within manufacturing and pharmaceutical environments.
- Ensure compliance with regulatory requirements and quality standards.
- Monitor and control product quality during the manufacturing process.
- Conduct process validation, verification, and quality control.
- Handle deviations, non-conformances, and audits efficiently.
Target Audience:
This course is ideal for quality assurance professionals, production managers, regulatory compliance officers, engineers, and other professionals involved in manufacturing and pharmaceuticals seeking to enhance their IPQA knowledge and skills.
Course Duration:
The course spans over 12 weeks, combining theoretical lessons, practical workshops, hands-on training, and real-world applications.
Certification:
Participants will receive a Certification in In-Process Quality Assurance (IPQA) Training upon successful completion of the course, validating their proficiency in IPQA principles, techniques, and regulatory compliance.
Enrollment:
Interested candidates can enroll in the IPQA Training course by visiting our website or contacting our admissions office.
Join Pertecnica Engineering and advance your career with our IPQA Training, equipping yourself with the skills and knowledge to ensure high standards of product quality and regulatory compliance in the pharmaceutical and manufacturing industries!