What is the focus of Quality Systems Training?
This training covers ICH Q10 quality systems, ALCOA+ data integrity principles, deviation and CAPA management, and risk management per ICH Q9.
Is the training relevant for our QA and QC departments?
Yes, this training is essential for QA/QC professionals, compliance officers, and managers responsible for quality operations and regulatory readiness.
What tools are included in the training package?
Participants receive CAPA templates, deviation investigation formats, ALCOA+ checklists, and risk ranking tools for immediate implementation.
Is this training aligned with ICH Q9 and Q10?
Yes, the training is fully based on ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System) guidelines.
Will this training help us prepare for regulatory inspections?
Absolutely. By strengthening documentation, deviation handling, and risk mitigation processes, this training helps your team meet regulatory expectations.
What topics are covered in the Quality Systems Training?
Our training covers ICH Q10 for quality culture, ALCOA+ data integrity, CAPA, deviation handling, and ICH Q9-based risk management, with practical case studies and strategies for GMP compliance.
Who should participate in this training program?
The program is ideal for quality assurance, regulatory affairs, manufacturing, and compliance professionals seeking to enhance quality systems, ensure data integrity, or prepare for regulatory audits.
How does the training ensure regulatory compliance?
Our training aligns with ICH Q10, ICH Q9, FDA 21 CFR Part 11, WHO QMS & Data Integrity Guidelines, and EU GMP Annex 1, ensuring your team meets global regulatory standards and audit requirements.
What materials are provided during the training?
Participants receive a training certificate, a CAPA/deviation toolkit, a data integrity checklist, QRM templates, and reference materials to support ongoing quality system compliance.
Can the training be customized for our organization’s needs?
Yes, our training is tailored to your organization’s specific processes, focusing on areas like quality culture, data integrity, or risk management to ensure practical and relevant outcomes.
What delivery formats are available for the training?
We offer flexible delivery options, including on-site, virtual, and hybrid formats, designed to accommodate your team’s preferences and ensure seamless learning experiences.