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- Digital Transformation of the Pharmaceutical Quality System
Advanced Training
Digital Transformation of the Pharmaceutical Quality System
Course information:
Training start date of the nearest stream
the minimum number of students required to run the course: 10 Discounts available for organized groups of three or more students
For more information, please call +7 (495) 676-43-12
the minimum number of students required to run the course: 10 Discounts available for organized groups of three or more students
For more information, please call +7 (495) 676-43-12
О курсе:
The Digital Transformation of the Pharmaceutical Quality System course is designed for pharmaceutical professionals who want to acquire knowledge and skills in digital technologies and their application in the quality system.
The course begins with the fundamentals of digital pharmacy, covering basic concepts and concepts, including the software used in the pharmaceutical industry. This is followed by a discussion of the automation of drug data collection and regulatory requirements for ensuring data integrity in computerized systems.
Special attention is given to data integrity and validation in computerized systems. The quality management system, its requirements, definition of procedures and effective management are reviewed. The validation life cycle "Providing Documented Proof of Conformity" and the approach to validation of computerized systems are also analyzed.
The course also covers the life cycle of a computerized system and the structure of project documentation. Special attention is paid to the application of information systems as tools for quality risk management.
The course also looks at the digital transformation of deviation management and risk management, as well as the potential application of artificial intelligence in the pharmaceutical quality system. At the end of the course, an example of parameter-based drug release is analyzed using sterile preparations as an example, as well as the application of an electronic batch file system.
The training in this course will equip professionals with the necessary knowledge and skills to effectively apply digital technology and quality systems in the pharmaceutical industry.
About the course:
- Fundamentals of digital pharmacy
- Used software in the pharmaceutical industry
- Automation of drug data collection
- Regulatory requirements for ensuring data integrity in computerized systems
- Data integrity and validation of computerized systems
- Quality Management System (QMS) - requirements, definition of procedures and effective management
- Validation Life Cycle "Providing Documented Evidence of Compliance"
- Approach to validation of computerized systems
- Life cycle of a computerized system, structure of project documentation
- Developing the concept of data integrity in a pharmaceutical quality system
- Information systems as tools for quality risk management
- Digital transformation of deviation management and risk management
- Opportunities for application of artificial intelligence
- Parameterized release using sterile pharmaceuticals as an example
- Application of the electronic dossier system for the series
Course Learning Objective:
Mastering the fundamentals of digital pharmacy and digital transformation of the quality system in the pharmaceutical industry
As a result of the course, trainees will know and understand:
- Principles and applied software in the pharmaceutical industry.
- Automation of drug data collection and regulatory requirements for ensuring data integrity in computerized systems.
- Quality Management System (QMS), its requirements, procedures and how to manage it effectively.
- The life cycle of validation of computerized systems and the creation of documented proof of compliance.
- Developing the concept of data integrity in a pharmaceutical quality system.
- The use of information systems in risk and quality deviation management.
- Application of artificial intelligence in the pharmaceutical industry.
- Parameterized drug release process using sterile preparations as an example.
- Application of an electronic dossier system for a series of medicines.
Attendees will learn how to apply digital tools and data analysis in the pharmaceutical industry, effectively manage a quality system, validate computerized systems, predict and manage risk, and apply emerging technologies and artificial intelligence to improve pharmaceutical quality system performance.
As a result of the course, trainees will know and understand:
- Principles and applied software in the pharmaceutical industry.
- Automation of drug data collection and regulatory requirements for ensuring data integrity in computerized systems.
- Quality Management System (QMS), its requirements, procedures and how to manage it effectively.
- The life cycle of validation of computerized systems and the creation of documented proof of compliance.
- Developing the concept of data integrity in a pharmaceutical quality system.
- The use of information systems in risk and quality deviation management.
- Application of artificial intelligence in the pharmaceutical industry.
- Parameterized drug release process using sterile preparations as an example.
- Application of an electronic dossier system for a series of medicines.
Attendees will learn how to apply digital tools and data analysis in the pharmaceutical industry, effectively manage a quality system, validate computerized systems, predict and manage risk, and apply emerging technologies and artificial intelligence to improve pharmaceutical quality system performance.
Target audience and learning outcomes:
- Employees of pharmaceutical manufacturers
- Staff of contract research organizations
- Employees of industry departments and organizations
Minimum requirements for trainees (any of the following):
University or vocational degreen
Credit hours:
36 academic hours
Mode of study:
Extramural, distance-learning
Duration:
2 weeks
Document to be issued:
Upon graduation, according to Federal Law 273-FZ "On Education in the Russian Federation", students are issued certificate of professional development of the established sample.
Presentation of the certificate:
The certificate can be presented to the listener personally, for this you must first to enroll by contacting the Academy by phone or e-mail.
If there is no possibility of personal receipt, the certificate will be sent by the delivery service documents with a tracking number assigned (delivery is free).
Contact information: E-mail:
info@gxp-academy.org Phone: +7 (495) 676-43-12
Register to Advanced Training
Digital Transformation of the Pharmaceutical Quality System