Pharma & Biotech

Advanced CMO Management: Selection, Qualification, and Operational Excellence

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

WHY SHOULD YOU ATTEND?

Select the right CMO with confidence

Learn how to assess technical, operational, and compliance capabilities before committing to a partner.

Strengthen your quality agreements

Define roles, deviation handling, change control, data ownership, and performance safeguards more clearly.

Improve CMO oversight

Use practical KPI, governance, audit, and monitoring approaches across multiple CMOs and geographies.

Prepare for CMO-related crises

Build readiness for deviations, batch failures, contamination events, escalation, CAPA, and recovery.

OUR ONLINE TRAINING EXPERIENCE INCLUDE

Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.

All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.

Receive a digital certificate (also Linkedin-ready) that verifies your skills.

LEARNING OBJECTIVES

Understand CMO regulatory expectations

Gain a clear overview of key EU and US requirements affecting outsourced manufacturing, inspections, and CMO oversight.

Select and qualify CMOs effectively

Learn how to assess technical, operational, compliance, and quality capabilities using risk-based evaluation methods.

Build stronger quality agreements

Understand how to define roles, responsibilities, deviation handling, change control, data ownership, and performance safeguards.

Improve CMO governance and performance monitoring

Learn how to use KPIs, audits, dashboards, and governance frameworks to manage multiple CMOs across geographies.

Strengthen crisis-response readiness

Develop practical approaches for escalation, communication, CAPA, and recovery during deviations, failures, or contamination events.

WHO IS THIS TRAINING FOR?

Designed for professionals who want to enhance their expertise and advance their careers

QA / QC Managers

External / Contract Manufacturing Managers

Regulatory Affairs Professionals

Compliance & GMP Auditors

Technical Operations & MSAT Leads

Quality Directors / Heads of Quality

CMC Project Managers

Supply Chain Directors

CMO Procurement & Supply Chain Managers

Technical Operations / CMC Directors

KEY TOPICS

Regulatory Requirements for CMOs in the EU and US

Selecting and Qualifying the Right CMO Partner

Designing and Negotiating High-Quality Agreements

Performance Monitoring and Governance Across Multiple CMOs

Crisis Management and Rapid Incident Response

TRAINER

Dr. Peter Riechel

T3 Consulting, Germany, Director

Peter is a GMP compliance expert with 25+ years in pharma, biopharma and medical devices, specializing in regulatory compliance and CMO oversight. With T3 Consulting, he has advised and supported companies in FDA audit readiness for authority inspections and remediation projects. Peter is also co-founder of T3GxPedia Consulting. His expertise spans Analytical Development, Quality Assurance, Sterile Manufacturing, Computer System Validation, Qualification and validation, AI in GMP environment, and Technology Transfer. Since 2013, Peter delivers practical, risk-based strategies and industry-specific solutions, making him a trusted advisor and interim manager.

Learn More →

Sneak Peek

Take a sneak peek at the trainer's presentation.

View PDF →

TESTIMONIALS

“Great course — well balanced, engaging, and highly relevant to both my current role and long-term career development. The speaker was very experienced, and the programme provided valuable practical guidance for the management of CMOs.”

Silvia Lissoni
Technical Operations Director, DOC Generici

“Very useful insights on CMO selection.”

Raphael Bauer
CMC Lead, AOP Health