What is WHO TRS GMP Training?

Our training program delivers comprehensive education on WHO Technical Report Series Annexes 1–9, covering sterile and API manufacturing, vaccine and biologic compliance, and global regulatory comparisons to ensure operational excellence.

Why is it Critical?

Understanding GMP expectations is vital for ensuring product quality, patient safety, and compliance with international regulations, helping teams navigate FDA, EMA, and WHO standards effectively.

Our Role in Your Success

As a trusted CRO, Indivirtus Healthcare Services provides expert-led training by experienced auditors and regulators, equipping your team with the knowledge and tools to achieve audit-ready compliance and operational efficiency.

Our Expert Training Approach

At Indivirtus Healthcare Services, our GMP training is crafted by experienced auditors and regulatory experts who bring global regulatory expertise to every session. We tailor our program to address WHO Technical Report Series Annexes 1–9, covering sterile manufacturing, API production, vaccine standards, and biologics compliance. Our training includes practical case studies, interactive Q&A sessions, and regulatory crosswalk guides to ensure your team is well-versed in FDA, EMA, and WHO requirements.

Our approach emphasizes real-world application, helping your team align operations with international quality standards. We deliver engaging, module-based sessions that foster deep understanding and practical skills, ensuring regulatory preparedness and operational excellence.

GMP Training Deliverables

Training Certificate: Official certification recognizing completion of WHO TRS-based GMP training.

Module-Wise PPTs: Comprehensive slide decks for each training module.

Case Studies and Q&A Material: Practical scenarios and interactive resources for enhanced learning.

Regulatory Crosswalk Guides: Detailed comparisons of WHO, FDA, and EMA regulations.

Training Reference Materials: Supplemental resources to support ongoing compliance.

Regulatory Compliance & Global Standards

Our GMP training services align with stringent global standards, ensuring your team is equipped to meet regulatory requirements and maintain audit-ready operations. By adhering to industry-leading guidelines, we provide training that supports compliance with international markets and enhances quality assurance.

  • WHO Technical Report Series Annexes 1–9: Comprehensive GMP guidelines for sterile, API, and biologic manufacturing.
  • WHO GMP Guidelines: Global standards for pharmaceutical quality assurance.
  • FDA CFR 21: U.S. regulations for good manufacturing practices.
  • EU GMP Volume 4: European guidelines for medicinal product manufacturing.
  • ICH Q7: Good manufacturing practice guide for active pharmaceutical ingredients.

Applications & Use Cases

Our GMP training services are essential for pharmaceutical professionals involved in sterile manufacturing, API production, vaccine development, and biologics compliance. The training is ideal for teams preparing for regulatory audits, onboarding new staff, or aligning operations with global standards. Key use cases include ensuring compliance during facility expansions, supporting new product launches, and enhancing quality assurance for global market access.

Why Choose Indivirtus Healthcare

Indivirtus Healthcare Services is a trusted partner for pharmaceutical manufacturers, delivering expert-led GMP training backed by certified toxicologists and regulatory experts with global experience. Our training ensures scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.

With a commitment to industry best practices, we empower your team with the knowledge and tools to achieve regulatory success and operational excellence, ensuring your operations remain compliant and competitive.

Frequently Asked Questions

Frequently Asked Questions

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.