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For Therapeutics, Biologics & Medical Devices

Quality Management System Requirements (QMSR) are foundational to ensuring that life sciences products are consistently safe, effective, and compliant with global regulations. This training equips professionals with the knowledge to implement and maintain robust quality systems across diverse product categories.

Executive Summary

Strategic cGxP Training for Pharmaceutical & Biologics Manufacturing: Embedding Compliance into Innovation

In the high-stakes world of pharmaceutical and biologics manufacturing, cGxP training is a strategic necessity. It ensures product quality, patient safety, and regulatory continuity across jurisdictions. With increasing harmonization, FDA’s 21 CFR Parts 210/211, EMA’s EudraLex Vol. 4, MHRA’s GxP guidance, and WHO TRS 986, organizations must cultivate a compliance culture that spans development, production, and post-market operations.

Yet, operational teams often face tension between throughput and compliance. Quality and regulatory functions are siloed from manufacturing and R&D, leading to reactive remediation rather than proactive control. This is especially critical in biologics, where process variability and patient-specific risks demand heightened vigilance.

Our training program transforms this tension into a strategic advantage. We integrate cGxP principles into daily operations, empowering teams to anticipate regulatory scrutiny, mitigate risk, and maintain control over critical quality attributes (CQAs). The curriculum is modular, role-specific, and jurisdictionally aligned, designed to harmonize global standards with local execution

Strategic Training Framework

Strategic cGxP Training: Operationalizing Compliance in Pharma & Biologics

Strategic Imperative

cGxP ensures product safety, efficacy, and traceability.
Global convergence: FDA, EMA, MHRA, WHO, ICH Q10.
Biology requires advanced control due to complexity and patient risk.
Compliance is a prerequisite for innovation and market access

Organizational Tensions

Manufacturing prioritizes speed, yield, and cost.
QA/RA prioritize documentation, control, and traceability.
R&D focuses on scalability and innovation.
Fragmented roles lead to audit exposure and regulatory delays.

Integration Opportunity

Embed cGxP into manufacturing, QC, and tech transfer workflows.
Train operators, scientists, and QA to speak a common compliance language.
Aligning CQAs, CPPs, and documentation with regulatory expectations.
Foster cross-functional fluency across biologics and small molecule teams.

Proactive Lifecycle Engagement

Early-stage training prevents late-stage deviations and recalls.
Role-based modules for QA, QC, Manufacturing, Regulatory, and Validation.
Process validation, cleaning verification, and cold chain control.
Risk-based auditing and deviation investigation protocols.
Post-market change control and pharmacovigilance integration.

Core Training Modules

Module 1: cGxP Fundamentals & ICH Q10 **Alignment:** FDA, EMA, MHRA, WHO
Module 2: GMP for Biologics & ATMPs **Alignment:** EMA Annex 2, FDA 21 CFR 600
Module 3: Process Validation & Control Strategy **Alignment:** FDA Guidance, EMA Annex 15
Module 4: Cleaning Validation & Contamination Control **Alignment:** EMA Annex 1, WHO TRS 986
Module 5: Documentation & Data Integrity
**Alignment:** FDA ALCOA+, MHRA GxP Data Integrity
Module 6: Deviation Management & CAPA
**Alignment:** FDA 211.192, EMA Chapter 1
Module 7: Cold Chain & Environmental Monitoring
**Alignment:** WHO PQS, EMA Annex 9
Module 8: Post-Market Surveillance & Change Control **Alignment:** FDA 314.70, EMA Chapter 1

Delivery Formats

🎓 Instructor-led workshops (virtual or onsite).
📚 Self-paced LMS modules with jurisdictional filters.
🧠 SME-led deep dives for high-risk operations.

Tools & Resources

Editable SOP templates and audit checklists.
Compliance gap analysis tools.
Batch record review simulators.
Regulatory reporting workflows.
Case studies from FDA, EMA, MHRA inspections.

Outcomes & Impact

🔍 Reduced regulatory observations and warning letters.
📈 Enhanced control over CQAs and batch release.
🧾 Improved documentation and traceability.
🌍 Strengthened compliance culture across global sites.
🚀 Accelerated innovation with built-in regulatory confidence.

Engagement Options

🌐 Enterprise-wide rollouts for global manufacturing networks.
🏭 Site-specific training for biologics and sterile facilities.
🚀 Strategic onboarding for new product launches.
💼 Cost-effective packages for CDMOs, CROs, and emerging biotechs.

What Is QMSR?

QMSR refers to the harmonized set of quality system expectations derived from:

ISO 13485 – Medical device quality management
ICH Q10 – Pharmaceutical quality systems
FDA 21 CFR Parts 210/211 & 820 – U.S. regulations for drugs and devices
EU MDR & IVDR – European requirements for medical devices and diagnostics

Product Type	Key Focus Areas
Therapeutics	GMP – batch records -deviation handling
Biologics	Cold chain – contamination control – sterility assurance
Medical Devices	Design controls – risk management – CAPA

Core QMS Elements

Document Control – SOPs, work instructions, and change management.
Training & Competency – Role-based education and qualification.
Risk Management – Proactive identification and mitigation
CAPA – Corrective and preventive actions for continuous improvement.
Supplier Quality – Audits, qualification, and performance monitoring.
Internal Audits – Routine checks to ensure system integrity

Why It Matters

Regulatory Approval – QMS compliance is a prerequisite for market access.
Patient Safety – Ensures product consistency and reliability.
Operational Excellence – Reduces errors, waste, and recalls.
Global Harmonization – Facilitates multi-market submissions and inspections.

Training Outcomes

Participants

Understand regulatory expectations across product categories.
Learn to implement QMS elements tailored to their domain.
Gain tools for audit readiness and continuous improvement.

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