CPHI Milan 2026 will be held from 6–8 October 2026 at Fiera Milano, Italy, serving as a key venue for pharmaceutical professionals to network, source partners, and explore industry trends. Organizations that prioritize internal compliance, particularly addressing GxP gaps, can maximize their value from the event and avoid risks associated with unresolved issues. Seven common compliance challenges for pharma and biotech companies should be tackled before the conference, which can be seen as the seven commandments.
Seven Commandments for Resolving Compliance Challenges
- Partial Inspection Readiness:
Organizations often underestimate the preparation time needed for regulatory inspections, which can expose gaps in documentation, training records, and CAPA effectiveness. Addressing these issues beforehand enables teams to confidently discuss their quality systems with potential partners or regulators.
- Data Integrity and Computer System Validation (CSV) Weaknesses
Electronic systems without adequate validation, audit trails, or access controls often lead to issues. Early attention to CSV gaps helps safeguard data integrity in clinical, manufacturing, and quality operations, showcasing maturity to potential partners.
- Inadequate Risk-Based Monitoring and Sponsor Oversight
Clinical trials necessitate advanced risk-based strategies and diligent sponsor oversight to ensure data quality and patient safety. Enhancing monitoring methods and vendor oversight prior to CPHI enables companies to demonstrate stronger clinical competencies.
- Outdated or Incomplete Quality Management Systems (QMS)
Updating a QMS is essential for sustainable compliance, as outdated Standard Operating Procedures (SOPs) and unclear responsibilities can hinder growth and adaptation to regulatory changes.
- GMP Compliance Across Manufacturing and Supply Chain
Unresolved GMP findings and gaps in supplier qualification pose ongoing risks for companies. Addressing these issues enhances confidence in discussions about manufacturing capacity and reliability.
- Training and Competency Gaps
Strong systems can fail if personnel lack knowledge of GxP requirements and internal procedures. Addressing training gaps is essential for maintaining compliance and effectively representing the organization in external discussions.
- Regulatory Dossier and Submission Gaps
Incomplete CTD modules and formatting issues can delay approvals; thus, reviewing and strengthening regulatory documentation beforehand facilitates better discussions on market access and partnership timelines.
How Zenovel Can Help
Zenovel will attend CPHI Milan 2026, providing practical support in GMP, GCP, regulatory affairs, CSV, QMS development, and clinical operations. The team assists companies in identifying gaps and implementing risk-based solutions to enhance inspection readiness. CPHI Milan serves as a valuable platform for addressing these challenges.
Schedule a meeting with Zenovel before the event.
Share your priorities with bd@zenovel.com to schedule a meeting in Milan. Clear compliance foundations at CPHI enable a focus on key discussions regarding partnerships, innovation, and growth, rather than internal risks.
We look forward to meeting you in Milan this October.