What is covered under WHO TRS Annex 1–9 training?
The training includes GMP expectations from WHO TRS Annexes 1–9, covering quality management, premises, production, documentation, and more.
How does this training help with FDA/EMA compliance?
We offer comparative analysis between WHO TRS, FDA, and EMA requirements, helping your team align practices globally.
Is this training relevant for sterile manufacturers?
Yes, the training includes specific modules on sterile manufacturing, including cleanroom design, aseptic process validation, and Annex 1 compliance.
Who should attend this WHO TRS training?
QA/QC professionals, production heads, regulatory affairs managers, and anyone involved in GMP implementation should attend.
Do participants receive certificates?
Yes, all participants receive a training certificate upon successful completion of the modules.
What topics are covered in the GMP training program?
Our GMP training covers WHO Technical Report Series Annexes 1–9, including sterile manufacturing, API production, vaccine and biologic compliance, and regulatory comparisons with FDA and EMA standards. It includes practical case studies and crosswalk guides for comprehensive learning.
Who should attend the WHO TRS GMP training?
This training is ideal for pharmaceutical professionals involved in manufacturing, quality assurance, regulatory affairs, or compliance roles. It’s perfect for teams preparing for audits, onboarding new staff, or seeking to align with global GMP standards.
How does the training ensure regulatory compliance?
Our training aligns with WHO TRS Annexes 1–9, FDA CFR 21, EU GMP Volume 4, and ICH Q7 guidelines, providing your team with the knowledge to meet international regulatory requirements and ensure audit-ready operations.
What materials are provided during the training?
Participants receive a training certificate, module-wise PPTs, case studies, Q&A materials, regulatory crosswalk guides, and supplemental reference materials to support ongoing compliance and learning.
Can the training be customized for our facility’s needs?
Yes, our training is tailored to your specific operational needs, focusing on your facility’s processes, whether in sterile manufacturing, API production, or biologics, ensuring relevance and practical application.
How is the training delivered, and is it available remotely?
Our training is delivered by experienced auditors and regulators through interactive, module-based sessions. It can be conducted on-site or remotely via virtual platforms, ensuring flexibility and accessibility for your team.