(AGENPARL) - Roma, 15 Marzo 2023

(AGENPARL) – SILVER SPRING mer 15 marzo 2023

Quality Management Systems: Learn the fundamentals of establishing an effective Quality Management System (QMS) and building a culture of quality within a facility. This course includes information about the comprehensive QMS approach to quality, the critical role of senior leadership, and building a quality culture mindset throughout the organization. The course will also explore the concepts of knowledge management, quality risk management, and data integrity. Practical activities will include the use of case studies, responding to inspectional observations and warning letters, conducting quality culture assessments, and evaluating data integrity risks.

• March 20 – 23, 2023
• July 24-27, 2023

Sterile Drug Compounding: Learn the basic principles, processes, and systems related to sterile drug production. The course integrates principles of aseptic processing, sterile filtration, cleanroom operations, facility cleaning and disinfection, aseptic process simulation (media fills), and environmental monitoring – all within the context of regulatory expectations.

 

Environmental Monitoring: Learn how to develop an environmental monitoring program and various sample collection methods through a combined teaching approach of lecture and practical activities.

• May 8 – 11, 2023
   

Investigations and Corrective and Preventative Actions (CAPA): Discover science-based methodology integrating problem solving techniques from total quality management (TQM), Six Sigma, Kaizen, and other techniques to identify the technical root causes, systemic root causes, corrective and/or preventive actions and a control plan for preventing recurrence.

• May 1 – 4, 2023

Process Validation: Learn general principles and approaches of Process Validation and the importance of ensuring control in the manufacturing process to produce consistent, quality products for patients.  This introductory course aligns process validation activities with a product lifecycle concept and existing FDA guidance documents for industry, including Process Validation: General Principles and Practices and the following FDA/International Council on Harmonisation (ICH) guidelines: Q8(R2), Pharmaceutical Development; Q9, Quality Risk Management; and Q10, Pharmaceutical Quality System, all developed to ensure product quality.

• May 15 – 18, 2023

Cleanroom: Learn through practical activities to highlight cleanroom performance tests such as airflow velocity and uniformity, high-efficiency particulate air (HEPA) filter leak testing and repairs and airflow visualization smoke studies.

• April 24 – 27, 2023
• August 21 – 24, 2023

Fonte/Source: http://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence-training-programs