Specialization Program in
Quality Management and Operations in the Pharmaceutical Sector
The program offers complete training in quality management for the pharmaceutical sector, addressing the fundamentals, systems and methodologies of continuous improvement, the implementation and audit of Good Manufacturing Practices, as well as Storage, Distribution and Transportation. It integrates the study of national and international regulations (DIGEMID, FDA, EMA), document management, traceability and performance indicators, and culminates with practical application in an integrative project that combines quality, compliance and operational efficiency, preparing the participant to lead and defend technical proposals in highly regulated environments.
Duration4 months
72 Hours
Start dateComing soon
Modality100% virtual
Platform Educational zoom and Moodle Duration4 months
72 Hours
Start dateComing soon Modality100% virtual Platform Educational zoom and Moodle Duration4 months
72 Hours
Start dateComing soon Modality100% virtual Platform Educational zoom and MoodleOur exhibitors
Armando
Jimenez San Vicente
CEO of Alamo Solutions LLC. Doctor in Political Economy (London Business School). Postdoctoral degree in Energy and Sustainability (Stanford). Master in Government and Administration (Harvard) and Law (Georgetown). Professor and academic director at the Ortega y Gasset Institute of the Complutense University of Madrid.
Javier
Benitez
Founding CEO of Sé Feliz Academy; executive coach and author of 12 books. MBA from IE Business School; Lic. in CCEE from the Complutense University of Madrid; Master in Happiness Studies Academy - New York. Teacher at Pacífico Business School.
Luis
Maravi Petrozzi
He leads the ACCEP Training School. He has been a manager at PAD, MiBanco and Bankboston. MBA and doctoral studies in Organizational Governance at the PAD. Industrial Engineer from the PUCP. Teaching experience at the PAD.
Maurice
Vallejos García
Specialist in Business Transformation and Analytics at BCP. He has been Senior Data Scientist at APOYO Consultoría. Bachelor in Economics (PUCP) and is studying MicroMasters in Statistics and Data Science at MIT. Postgraduate teaching experience at prestigious universities.
John
Olivares
He has extensive experience in Regulatory Affairs and Quality Management. He has been Regulatory Affairs Manager at Johnson & Johnson and Fresenius Medical Care, as well as Regulatory Affairs and Quality Manager at Siemens Healthcare, AstraZeneca and Tecnofarma. He studies a doctorate in Public Health and Global Health, has an MBA in Health (UPC) and a degree in Pharmaceutical Chemist (UNMSM), as well as specializations in management, medical devices and public policies. He is a postgraduate professor at prestigious universities.
Lady
Baltodano
Production Manager in Grünenthal (Quito). More than 20 years of experience in the pharmaceutical industry, she has been Production Manager, Packaging Production Manager, Head of Solids Production, Research and Development Assistant and Head of Penicillin Production at Abbott – Farmindustria (Peru). She is a Pharmaceutical Chemist from UNMSM, has a Master's Degree in Leadership and Senior Business Management (UNMSM), as well as specializations in Project Management (UNI). She has been an internal trainer on Good Manufacturing Practices (GMP), Lean Six Sigma, continuous improvement and production management in pharmaceutical industrial environments.
Xavier
Gimbert
He has been a teacher at ESADE Business School. Director at ESADE, Pacífico Business School and ESPAE (Guayaquil). PhD in Business Administration from the Ramón Llull University and MBA from ESADE.
Armando
Jimenez San Vicente
CEO of Alamo Solutions LLC. Doctor in Political Economy (London Business School). Postdoctoral degree in Energy and Sustainability (Stanford). Master in Government and Administration (Harvard) and Law (Georgetown). Professor and academic director at the Ortega y Gasset Institute of the Complutense University of Madrid.
Javier
Benitez
Founding CEO of Sé Feliz Academy; executive coach and author of 12 books. MBA from IE Business School; Lic. in CCEE from the Complutense University of Madrid; Master in Happiness Studies Academy - New York. Teacher at Pacífico Business School.
Luis
Maravi Petrozzi
He leads the ACCEP Training School. He has been a manager at PAD, MiBanco and Bankboston. MBA and doctoral studies in Organizational Governance at the PAD. Industrial Engineer from the PUCP. Teaching experience at the PAD.
Maurice
Vallejos García
Specialist in Business Transformation and Analytics at BCP. He has been Senior Data Scientist at APOYO Consultoría. Bachelor in Economics (PUCP) and is studying MicroMasters in Statistics and Data Science at MIT. Postgraduate teaching experience at prestigious universities.
John
Olivares
He has extensive experience in Regulatory Affairs and Quality Management. He has been Regulatory Affairs Manager at Johnson & Johnson and Fresenius Medical Care, as well as Regulatory Affairs and Quality Manager at Siemens Healthcare, AstraZeneca and Tecnofarma. He studies a doctorate in Public Health and Global Health, has an MBA in Health (UPC) and a degree in Pharmaceutical Chemist (UNMSM), as well as specializations in management, medical devices and public policies. He is a postgraduate professor at prestigious universities.
Lady
Baltodano
Production Manager in Grünenthal (Quito). More than 20 years of experience in the pharmaceutical industry, she has been Production Manager, Packaging Production Manager, Head of Solids Production, Research and Development Assistant and Head of Penicillin Production at Abbott – Farmindustria (Peru). She is a Pharmaceutical Chemist from UNMSM, has a Master's Degree in Leadership and Senior Business Management (UNMSM), as well as specializations in Project Management (UNI). She has been an internal trainer on Good Manufacturing Practices (GMP), Lean Six Sigma, continuous improvement and production management in pharmaceutical industrial environments.
Xavier
Gimbert
He has been a teacher at ESADE Business School. Director at ESADE, Pacífico Business School and ESPAE (Guayaquil). PhD in Business Administration from the Ramón Llull University and MBA from ESADE.
Armando
Jimenez San Vicente
CEO of Alamo Solutions LLC. Doctor in Political Economy (London Business School). Postdoctoral degree in Energy and Sustainability (Stanford). Master in Government and Administration (Harvard) and Law (Georgetown). Professor and academic director at the Ortega y Gasset Institute of the Complutense University of Madrid.
Specialty Modules
1
ModuleFundamentals of Quality Management
- +Fundamentals and quality management systems.
- +Document management.
- +Continuous improvement methodologies.
- +Performance indicators.
- +CAPA Methodology: Corrective And Preventive Action.
- +Quality in the pharmaceutical sector.
- +Activity: Definition of performance indicators for quality management in a pharmaceutical establishment.
2
ModuleGood Manufacturing Practices - BPM
- +Environment of a pharmaceutical laboratory.
- +Quality management in a laboratory.
- +Requirements for good manufacturing practices.
- +BPM audit.
- +CAPA - Corrective And Preventive Action in BPM.
- +Key performance indicators.
- +National and international regulatory regulations: DIGEMID, FDA, EMA.
- +Product traceability and document management.
- +Activity: Prepare a basic manual of the quality system with an audit checklist
3
ModuleGood Storage, Distribution and Transportation Practices
- +Surroundings of a drugstore.
- +Quality management in a drugstore.
- +Requirements for good storage, distribution and transportation practices.
- +BPA, BPDyT audit.
- +LAYER in BPA, BPDyT.
- +Key performance indicators.
- +Activity: Prepare a proposal for the implementation of a quality management system for a drugstore.
4
ModuleOperational Integration
- +Integration of quality, compliance and operational efficiency.
- +Practical cases of implementation of integrated systems.
- +Management of multidisciplinary teams in regulated areas.
- +Preparation of regulatory reports and executive presentation.
- +Simulation of project defense before a technical committee.
- +Integrative Project: Design an operational and pharmaceutical quality plan: process map, quality system, risk matrix and improvement plan, presentation of results and implementation proposals.
Transversal Modules
5
Module
Digital Competencies
With a practical focus on technology, participants will be able to apply the most relevant digital tools on the market.
- Excel for data modeling.
- Data visualization with Power BI.
- AI for productivity and data analysis.
6
Module
Leadership and Soft Skills
The key leadership capabilities of the participants will be enhanced, allowing them to inspire, guide and enhance their work teams.
- The keys to the leader.
- Transformative leadership.
- Effective communication.
- Delegation and coaching.
- Critical thinking.
- Integrity as a competitive advantage.
7
Module
Acceleration of Employability
Enhance your personal brand and positioning in the labor market through practical workshops.
- WORKSHOP: LinkedIn networking and management techniques.
- WORKSHOP: Personal brand.
- WORKSHOP: Preparation for interviews.
8
Module
International Immersion: Trends that Configure the Future of Work
It offers a global vision of the trends that transform the world of work, focusing on the impact on employability and future skills.
- Conference: Impact of the trade war between the USA and China on the global economy.
- Conference: Recruitment by values: Cultural feed.
- Conference: Strategy in the era of uncertainty.
Specialty skills
- Implement quality management systems in pharmaceutical environments.
- Apply BPM, BPA and BPDyT according to regulatory standards.
- Use CAPA methodologies and continuous improvement to optimize processes.
- Integrate quality and operations with indicators and documentary control.
- Design an operational and quality plan for the pharmaceutical sector.
Featured attributes of the program
Comprehensive modular design that combines specialization, leadership, employability and international immersion skills on topics that set the global agenda
Progressive certification in each Specialty Module.
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Practical approach, based on activities, real cases and a project in which they will develop an operational and pharmaceutical quality plan that includes: Integration of the process map, quality system, risk matrix and improvement plan.
*UCV+ Executive Development Center reserves the right to reschedule or cancel the start of the program if the minimum number of participants is not reached, communicating said decision in a timely manner to those registered.
