Validación y transferencia de métodos de análisis
Barcelona , Spain
Tuition Fee
EUR 750
Per year
Start Date
Medium of studying
On campus
Duration
1.0 days
Program Facts
Program Details
Degree
Courses
Major
Applied Statistics | Statistics | Numerical Analysis
Area of study
Mathematics and Statistics
Education type
On campus
Timing
Full time
Course Language
English
Tuition Fee
Average International Tuition Fee
EUR 750
About Program
Program Overview
This one-day program, "Validation and Transfer of Analytical Methods," teaches participants how to design validations and perform statistical analysis in accordance with ICH Q2R2 and USP<1225> guidelines. It also covers method transfer techniques based on ISPE and USP <1224> guidelines, enabling participants to efficiently conduct method validation and transfer within the pharmaceutical industry.
Program Outline
Degree Overview:
- Program Name: Validación y transferencia de métodos de análisis It aims to equip them with the knowledge and skills to understand auditor expectations for validations and transfers, and to efficiently conduct method transfers. The program also addresses the identification of root causes for failed transfers.
- Objectives:
- Explain the ICH Q2R2 and USP<1225> guidelines that regulate the validation of analytical methods in the pharmaceutical sector.
- Explain how to efficiently design and perform the validation of analytical methods.
- Explain the ISPE and USP <1224> guidelines for the transfer of analytical methods.
- Explain how to efficiently design and perform the transfer of analytical methods.
Outline:
- Content:
- Introduction to the concept of analytical method validation
- ICH Q2R2 and USP <1225> guidelines
- Methodology for designing and conducting studies on:
- Selectivity and sensitivity
- Linearity and accuracy
- Repeatability and intermediate precision
- Robustness
- Acceptance criteria
- Introduction to the concept of method transfer and types of transfer
- ISPE and USP <1224> guidelines
- Methodology for efficiently performing a transfer
- Revalidation criteria
- Practical workshop:
Teaching:
- Teaching Methods:
- The program is delivered in a face-to-face format to encourage personal interaction between participants and professors.
- The program incorporates aspects such as cross-learning among participants, skill development, networking, and personal mentoring.
- Face-to-face sessions facilitate the operationalization of these dynamics.
- The program emphasizes practical learning through various dynamics designed to foster an effective and stimulating learning process.
- Faculty:
Other:
- Target Audience: Laboratory managers of chemical and microbiological analysis, quality assurance managers, quality control technicians, and quality assurance technicians.
- Duration: 1 day
- Format: On-campus
- Hours: 8
- Schedule: 9:30h – 18:30h
- Price: 750€
- City: Barcelona
- Certification: IQS issues a Certificate of Completion to those who complete the entire program.
- Cancellation Policy: Participants or companies can request cancellation of registration up to 15 days before the program starts, and IQS will refund the full amount. After this deadline or once the program has started, IQS will decide whether a refund is appropriate and the amount to be reimbursed, if applicable. In this case, IQS will contact the participant or company to proceed with a full refund of the amounts paid.
- Financial Aid: IQS may offer the possibility of deferring payment in several installments, with an initial payment upon reservation of a place.
- Discounts:
- Members of the Fundació Empreses IQS.
- Companies that have previously trained collaborators at IQS Executive Education.
- Companies registering more than one participant in the same program and edition.
- Fundae (Tripartita) Bonification: The program is eligible for bonification, with the amount or percentage depending on the teaching hours, modality, and other criteria outside of IQS.
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About University
Overview:
IQS - Ramon Llull University is a private university located in Barcelona, Spain. It is known for its focus on science, engineering, and management, offering a comprehensive range of programs in these fields. IQS is committed to educational excellence and aims to improve the future of society through its research and teaching.
Services Offered:
The university provides a variety of services to its students, including:
Academic advising:
Students have access to academic advisors who can help them with course selection, career planning, and other academic matters.Career services:
IQS offers career services to help students find internships and jobs after graduation.Library and research resources:
The university has a well-stocked library and access to a variety of research databases.Student support services:
IQS provides student support services such as counseling, tutoring, and disability services.Student Life and Campus Experience:
IQS offers a vibrant campus life with a variety of activities and events for students to participate in. The university has a strong international focus, with students from all over the world. Students can expect to:
Engage in research:
IQS encourages student involvement in research projects, providing opportunities to work alongside faculty and contribute to cutting-edge discoveries.Network with professionals:
The university hosts events and workshops where students can connect with industry professionals and learn about career opportunities.Join student clubs and organizations:
IQS has a variety of student clubs and organizations that cater to different interests, providing opportunities for students to develop leadership skills and build friendships.Key Reasons to Study There:
Strong academic reputation:
IQS is recognized for its high-quality academic programs and its commitment to research.International focus:
The university has a diverse student body and offers a variety of international programs.Industry connections:
IQS has strong ties to the business community, providing students with opportunities for internships and jobs.Modern facilities:
The university has state-of-the-art facilities, including laboratories, workshops, and classrooms.Academic Programs:
IQS offers a wide range of academic programs, including:
Bachelor's Degrees:
The university offers bachelor's degrees in a variety of fields, including chemistry, chemical engineering, biotechnology, biomedical sciences, pharmacy, industrial engineering, business administration and management, marketing, international business, and tourism and hospitality management.Dual Bachelor's Degrees:
IQS also offers dual bachelor's degrees, allowing students to combine their studies in two different fields.Master's Degrees:
The university offers master's degrees in a variety of fields, including analytical chemistry, pharmaceutical chemistry, chemical engineering, industrial engineering, bioengineering, biopharmaceutical business, cosmetics and fragrances, global entrepreneurial management, international marketing in a digital environment, auditing and management control, wealth and financial management, and industrial business management.Dual Master's Degrees:
IQS also offers dual master's degrees, allowing students to combine their studies in two different fields.PhD Programs:
The university offers PhD programs in bioengineering, chemistry and chemical engineering, and business and territorial competitiveness, innovation, and sustainability.Executive Education:
IQS offers a variety of executive education programs for professionals who want to advance their careers.Other:
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