SERVICES | TRAINING
Comprehensive Solutions Tailored to Your Regulatory and Quality Needs
SERVICES
TRAINING
Our trainings options are focus on covering
the main topics related to Quality Systems in
target sector. Those could be online in site,
designed according to customer’s needs.
GxP (GMPs, GDP, GWP)
Data Integrity
Project Management
Validation/ Qualification
Risk Assessment
Change Control
GxP (GMPs, GDP, GWP)
- GxP training focus on cover all the bases of GxP, including GMP, GDP, GWP, etc.
- The main objective of these trainings is to empower the participant to learn the bases to prevent GxP failures, providing the tools for the review of Quality Process Quality, to know the strategies for ensuring GxP Compliance in the Face of Cost Reduction.
Data Integrity (DI)
- DI course provide the tools to warranty the completeness, consistency, and accuracy of data in compliance with ALCOA principles.
- The main objective of this training is providing the bases of ALCOA principles, to know the data life cycle including but not limited to data creation, processing, archiving and dispositions after the record’s retention period.
- Data Integrity courses are designed and adapted to the needs of our clients, with the aim of meeting their expectations.
Project Management.
- This course is geared towards providing the bases for Project management including GAP Analysis, the work plan definition for long and short term, resources management, risk
- management, etc.
Validation/Qualification.
- Process validation involves different kind of stages including Validation Master Plan definition, data collection, lifecycle management approach definition, Validation Risk Assessment, System Inventory and Projects schedule, etc. Under this training the participant know the bases of Process Validations.
- This course could be designed and adapted according with participants and customer’s needs.
Risk Management.
- The Risk Management is critical in decision-making under a regulated environment. Under this training the Risk Management bases will be review and the tools for its well implementation in site.
Change Control.
- Change Control as well as Risk Management are critical in decisionmaking and Quality Systems Compliance, under a regulated environment. Under this training the participant will get the tools and knowledge to follow the best practice on Change Management to ensure that Quality System follows regulatory requirements.