Giulia AURIEMMA | QUALITY ASSURANCE IN THE PHARMACEUTICAL INDUSTRY
Giulia AURIEMMA QUALITY ASSURANCE IN THE PHARMACEUTICAL INDUSTRY
cod. 0760200031
QUALITY ASSURANCE IN THE PHARMACEUTICAL INDUSTRY
| 0760200031 | |
| DIPARTIMENTO DI FARMACIA | |
| EQF7 | |
| PHARMACEUTICAL CHEMISTRY AND TECHNOLOGY | |
| 2018/2019 |
| YEAR OF DIDACTIC SYSTEM 2010 | |
| SECONDO SEMESTRE |
| SSD | CFU | HOURS | ACTIVITY | |
|---|---|---|---|---|
| CHIM/09 | 5 | 40 | LESSONS |
| Objectives | |
|---|---|
| COURSE OBJECTIVES AND LEARNING OUTCOMES THE AIM OF THE COURSE IS TO PROVIDE THE STUDENTS WITH A SET OF INSTRUMENTS AND METHODOLOGIES TO UNDERSTAND PRINCIPLES AND FEATURES OF A PHARMACEUTICAL INDUSTRY, PARTICULARLY IN RELATION TO QUALITY ASSURANCE ASPECTS. AT THE END OF THE COURSE, STUDENTS MUST HAVE ACQUIRED KNOWLEDGE, SKILLS AND COMPETENCES USEFUL FOR THE MANAGEMENT OF QUALITY IN A PHARMACEUTICAL INDUSTRY. KNOWLEDGE AND UNDERSTANDING SKILLS - KNOWLEDGE OF PHARMACEUTICAL INDUSTRY REGULATIONS - KNOWLEDGE OF SYSTEMS AND INSTRUMENTS FOR MANAGEMENT, CONTROL AND QUALITY CERTIFICATION. - KNOWLEDGE OF METHODS FOR THE ANALYSIS OF: PRODUCTION, CONTROL AND DISTRIBUTION OF PHARMACEUTICAL PRODUCTS. - KNOWLEDGE OF METHODS AND INSTRUMENTS FOR IMPLEMENTING MODELS OF QUALITY CERTIFICATION. KNOWLEDGE AND APPLIED SKILLS - ABILITY TO USE THE ACQUIRED KNOWLEDGE FOR THE MANAGEMENT OF DIFFERENT PRODUCTION FACTORS. - ABILITY TO EVALUATE THE IMPACT OF DIFFERENT MODELS/ APPROACHES ON QUALITY CERTIFICATION. - ABILITY TO MANAGE COMPLEX SITUATIONS FOR THE IMPLEMENTATION, AND SUBSEQUENT CERTIFICATION, OF PHARMACEUTICAL QUALITY SYSTEMS - ABILITY TO COMMUNICATE AND EXPRESS PROBLEMS CONCERNING THE MANAGEMENT OF QUALITY, BOTH INSIDE AND OUTSIDE THE ORGANIZATION. SOFT SKILLS - CRITICAL ANALYSIS AND DECISION MAKING SKILLS TO MAKE JUDGEMENTS REGARDING COMPLEX QUALITY ASSURANCE ISSUES IN PHARMACEUTICAL PRACTICE. - ABILITY TO NEGOTIATE BETWEEN MEMBERS OF A GROUP WITHIN A SINGLE ORGANIZATION OR BETWEEN MEMBERS OF MULTIPLE ORGANIZATIONS. - ABILITY TO DEEPEN COMPLEX ISSUES AND ASSUME RESPONSIBILITY IN THE DEVELOPMENT AND/OR APPLICATION OF ORIGINAL IDEAS. |
| Prerequisites | |
|---|---|
| PREREQUISITES NONE. HIGHLY RECOMMENDED BASIC KNOWLEDGE: - PREPARATION AND CONTROL OF PHARMACEUTICAL PRODUCTS - PREMISES AND EQUIPMENTOF OF A PHARMACEUTICAL INDUSTRY - "UNITARY" OPERATIONS FOR THE PREPARATION OF MEDICINAL PRODUCTS |
| Contents | |
|---|---|
| COURSE CONTENTS 1. INTRODUCTION QUALITY CONCEPTS IN THE PHARMACEUTICAL INDUSTRY INTRODUCTION ON R&D (DISCOVERY, DEVELOPMENT AND MARKETING) AND QUALITY SYSTEM (QA) IN THE PHARMACEUTICAL INDUSTRY ORGANIZATION, PERSONNEL AND KEY ROLES (PRODUCTION – QUALITY CONTROL - QUALITY ASSURANCE – PHARMACOVIGILANCE – REGULATORY AFFAIRS) 2. REGULATORY PARADIGMS OF GOVERNANCE AND REGULATION OF QUALITY LEGISLATION, REGULATORY GUIDANCE AND RELATED DOCUMENTS REGULATORY AUTHORITIES (AIFA, EMA, FDA, ETC.) GOOD MANUFACTURING PRACTICES (GMP) PRODUCTION AUTHORIZATION (PA) AND MARKETING AUTHORIZATION (AIC) OF A MEDICINAL PRODUCT (LEGISLATIVE PROCEDURES) NEW QUALITY PARADIGMS: ICH Q-8 (QUALITY BY DESIGN), ICH Q-9 (QUALITY RISK MANAGEMENT) AND ICH Q-10 (PHARMACEUTICAL QUALITY SYSTEMS). 3. PHARMACEUTICAL QUALITY MANAGEMENT SYSTEM GOOD MANUFACTURING PRACTICES (GMPS) - EUDRALEX VOLUME 4 (DIRECTIVE 2003/94 / EC) PHARMACEUTICAL QUALITY SYSTEM PERSONNEL AND ORGANIZATION. PERSONNEL QUALIFICATION. TRAINING. “QUALIFIED PERSON” ETC. PREMISE AND EQUIPMENT DOCUMENTATION. GENERATION AND CONTROL OF DOCUMENTATION. STANDARD OPERATIVE PROCEDURES (SOP). MASTER BATCH RECORD. SITE MASTER FILE (SMF), ETC. PRODUCTION AND QUALITY CONTROL. PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION; VALIDATION; PROCESSING OPERATIONS: INTERMEDIATE AND BULK PRODUCTS; PACKAGING MATERIALS; FINISHED PRODUCTS. INSPECTIONS OOT (OUT-OF-TREND) EVALUATION; OOS (OUT OF SPECIFICATION) AND DEVIATIONS MANUFACTURE OF STERILE MEDICINAL PRODUCTS 4. ISO 5. EUDRALEX VOLUME 4_ ANNEXES 6. SEMINARS WITH EXPERTS FROM SEVERAL PHARMACEUTICAL INDUSTRIES |
| Teaching Methods | |
|---|---|
| METHODS AND DIDACTIC STRATEGIES LECTURES, SEMINARS, GROUPS OF STUDY OR WORK, PROJECT WORK, INTERACTION WITH THE TEACHER AND WITH EXPERTS OF THIS SECTOR. |
| Verification of learning | |
|---|---|
| VERIFICATION OF STUDENTS' RESULTS THE ACHIEVEMENT OF THESE OBJECTIVES WILL BE VERIFIED BY BOTH A WRITTEN AND AN ORAL EXAM; THE EVALUATION WILL BE EXPRESSED IN THIRTIETHS. IN ORDER TO TAKE THE ORAL EXAM, IT IS NECESSARY TO PASS THE WRITTEN EXAM (MINIMUM MARK 18/30). THE WRITTEN TEST WILL BE CARRIED OUT AT THE END OF THE COURSE; IT IS AIMED AT EVALUATING KNOWLEDGE AND SKILLS; IT WILL BE ARTICULATED INTO APPROXIMATELY 20 QUESTIONS (MAXIMUM DURATION: 90 MINUTES). THE ORAL EXAM IS AIMED AT EVALUATING THE THEORETICAL KNOWLEDGE, THE AUTONOMY OF ANALYSIS, THE ABILITY TO REWORK CONTENTS INTO THE CORRECT FORMAT FOR PROFESSIONAL USE. THE FINAL EVALUATION IS OBTAINED AS THE MEDIUM OF EACH PARTIAL MARKS. THE MINIMUM MARKS (18/30) IS ATTRIBUTED TO STUDENTS WITH A FRAGMENTARY KNOWLEDGE AND A LIMITED CAPACITY TO REWORK THE TREATED CONCEPTS. THE MAXIMUM MARKS (30/30) IS ATTRIBUTED TO STUDENTS ABLE TO DEMONSTRATE A COMPLETE KNOWLEDGE OF THE METHODOLOGIES AND A NOTABLE ABILITY TO REWORK CONTENTS. THE PRIDE WILL BE ATTRIBUTED ONLY TO STUDENTS WITH A SIGNIFICANT MASTERY OF THE METHODOLOGIES, WITH A HIGH ABILITY TO REWORK THE ACQUIRED KNOWLEDGE. |
| Texts | |
|---|---|
| RECOMMENDED BOOKS EU LEGISLATION – EUDRALEX (LINK HTTP://EC.EUROPA.EU/HEALTH/DOCUMENTS/EUDRALEX/INDEX_EN.HTM) PRINCIPI DI TECNOLOGIA FARMACEUTICA. PAOLO COLOMBO, FRANCO ALHAIQUE, CARLA CARAMELLA, BICE CONTI, ANDREA GAZZANIGA, ELENA VIDALE - SECONDA EDIZIONE. CASA EDITRICE AMBROSIANA. ZANICHELLI LEGISLAZIONE FARMACEUTICA DI: PAOLA MINGHETTI, MARCELLO MARCHETTI EDITORE: CEA EDIZIONE: 8 |
| More Information | |
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