Tailored In-House Training

GMP for Middle Management – Radiopharmaceuticals

Updated Wednesday, April 15, 2026 at 8:01 PM

A two-day classroom training that equips middle management in radiopharmaceutical manufacturing with a thorough understanding of EU GMP requirements, quality culture, and practical tools to translate regulations into daily operations.

Custom On-Site Training

This training is delivered at your location and tailored to your organization's specific needs, processes, and compliance requirements.

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What's included

Program tailored to your organization
Delivered at your location
Flexible scheduling
Training certificate for participants
Experienced trainers from industry and regulatory

Difficulty

Intermediate level

Topics

Change Control GMP EudraLex Volume IV QC Calibration Validation Qualification CSV Quality Culture Sampling Batch Review Manufacturing CCS Sterile Aseptic Writing Procedures OOS Qualified Person Management Review Data Integrity ALCOA Raw Data CAPA Impact Assessment Rootcause Analysis Human Error QMS Risk Assessment Complaints QP Skills Trending QP Declaration Licenses Training Facility Equipment Cleaning Validation Documentation Annex 11 Computerized Systems Data Integrity GDocP Critical Parameters Sampling Outsourcing Risk Ranking Recall Returns IGJ Utilities Sterility Assurance Auditing

Also available as in-house

What you will learn

Describe the importance and essence of GMP through a solid overview of pharmaceutical legislation and regulations, including EudraLex Volume 4 and key annexes

Explain the elements of a Pharmaceutical Quality System (ICH Q10) including change control, deviations, CAPAs, and quality risk management

Recognize the role and responsibilities of middle management in fostering a strong quality culture and reducing human errors

Apply validation, qualification, calibration, and verification principles to equipment and processes in a radiopharmaceutical environment

Implement Good Documentation Practice (GDocP) and data integrity principles (ALCOA+) in daily operations

Evaluate contamination control strategies and Annex 1 requirements relevant to sterile radiopharmaceutical manufacturing

Assess supplier qualification, outsourced activities, and the role of the Qualified Person in batch release

Develop concrete action plans to translate GMP theory into practical improvements within their own organization

Description

The motivation and insight of employees at middle management level plays an indispensable role in quality management within the pharmaceutical industry. It is precisely this group that is frequently and intensively involved in setting up, improving, and applying quality systems. This training covers the essential elements of a pharmaceutical quality system and supporting activities such as validation, qualification, and change control.

This variant is specifically tailored to the radiopharmaceutical manufacturing environment, incorporating EU GMP Annex 1 (Manufacture of Sterile Medicinal Products) and Annex 3 (Manufacture of Radiopharmaceuticals) alongside the core EudraLex Volume 4 chapters. Workshops and case studies use scenarios and deviations relevant to radiopharmaceutical production, including Aseptic Process Simulation exercises, contamination control strategies for sterile radiopharmaceuticals, and real deviation cases from radiopharmaceutical manufacturing sites.

The training is structured around the nine chapters of EU GMP Part I (Basic Requirements), supplemented with practical workshops on deviations, risk management, contamination control strategy, and a closing session where participants develop concrete action plans to improve GMP compliance in their own workplace. Daily content is kept up to date with the most recent developments in European GMP guidelines.

The training concludes with an interactive Kahoot quiz to test knowledge retention, and participants receive a Certificate of Attendance upon completion.

Target Audience

This training is designed for employees at middle management level in radiopharmaceutical manufacturing who need a comprehensive overview of GMP regulations. QA Officers and Managers, Qualified Persons, QC Managers and Analysts, Production Managers, and Supervisors working with radiopharmaceuticals will find this training particularly valuable.

The curriculum follows the nine chapters of EU GMP EudraLex Volume 4 Part I (Basic Requirements), supplemented with key annexes relevant to radiopharmaceutical manufacturing: Annex 1 (Sterile Medicinal Products), Annex 3 (Radiopharmaceuticals), Annex 8 (Sampling), Annex 11 (Computerised Systems), Annex 15 (Qualification and Validation), Annex 16 (QP Certification and Batch Release), and Annex 19 (Reference and Retention Samples). Practical workshops, case studies, and interactive exercises are integrated throughout both days.

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Program

Lecture	Day
Course Introduction Welcome, introduction of participants, learning objectives, and program overview.	1
GMP Legislation and Regulations Overview of pharmaceutical legislation: EudraLex Volume 4, the Medicines Act, European Commission, EMA, PIC/S, ICH, FDA, and WHO. The regulatory framework as foundation for pharmaceutical quality.	1
Chapter 1: Pharmaceutical Quality System Quality systems, modern GMP thinking, ICH Q10 model, Management Review, and Product Quality Review. Moving beyond compliance to a process-oriented approach.	1
Chapter 1: Essential Elements – Change Control, Deviations, CAPAs & Risk Management Practical examples of essential quality system elements: how to manage changes, handle deviations, implement corrective and preventive actions, and apply quality risk management.	1
Deviations Workshop Hands-on workshop using real-world deviation scenarios from radiopharmaceutical manufacturing. Participants practice root cause analysis using fishbone diagrams and 5-Why methodology.	1
Chapter 2: Personnel Personnel responsibilities, the importance of training, introduction to quality culture, and understanding human errors. Includes personal assessment tools and quality culture building blocks.	1
Chapter 3: Premises and Equipment Equipment requirements, validation, qualification, calibration, and verification. Understanding the difference between validation and qualification, process validation via the V-model, and cleaning validation essentials.	1
Chapter 4: Documentation GMP documentation requirements, data integrity principles (ALCOA+), Good Documentation Practice (GDocP), and Good Writing Practices. Including reference to MHRA Data Integrity Guidance.	1
Day 1 Closing Summary of key takeaways, open questions, and preview of day 2.	1

Lecture	Day
Day 2 Introduction Review of day 1 key concepts, questions and answers, and program overview for day 2.	2
Chapter 5: Production Production principles, critical process parameters (CPPs) and critical quality attributes (CQAs). Workshop on identifying CPPs and CQAs in a radiopharmaceutical production context.	2
Contamination Control and Annex 1 Contamination Control Strategy for sterile radiopharmaceutical manufacturing. Requirements of EU GMP Annex 1 (Manufacture of Sterile Medicinal Products) and Annex 3 (Manufacture of Radiopharmaceuticals). Includes Aseptic Process Simulation exercises.	2
The Role of the Qualified Person Regulatory basis, responsibilities, qualification requirements, and the batch release process. The importance of an effective quality system for the QP role. EU GMP Annex 16.	2
Chapter 6: Quality Control Quality Control fundamentals, sampling procedures (Annex 8), reference and retention samples (Annex 19), and Out of Specification (OOS) investigation procedures.	2
Chapter 7: Outsourced Activities Supplier and contractor qualification, risk ranking of starting materials and suppliers, quality agreements, and auditing essentials for outsourced activities.	2
Chapter 8: Complaints, Returns and Product Recall Handling complaints, managing returns, and executing product recalls in a radiopharmaceutical manufacturing context.	2
Chapter 9: Self-Inspection Requirements for self-inspections, common pitfalls, and how to run effective internal audits.	2
Workshop: GMP in Your Own Practice Participants develop concrete action plans to translate the training content into practical improvements within their own organization and daily work.	2
Kahoot Quiz and Training Closing Interactive knowledge quiz covering both training days, followed by certificate presentation and closing remarks.	2

Results

After completing this training, participants will have the knowledge to interpret GMP regulations more easily and translate them into daily practice. They will gain insight into potential gaps within their own organization and a heightened awareness of the importance of GMP in daily operations. Participants will be able to implement GMP principles in practice with an understanding of quality culture, and deal effectively with the specific position of middle management in a pharmaceutical organization.

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Resources

Training

Popular Categories

Good Distribution Practices (GDP) - including the Responsible Person (blended)

Deviation & CAPA Management

GMP for Middle Management – Radiopharmaceuticals

Custom On-Site Training

What's included

Difficulty

Topics

Categories

Also available as in-house

What you will learn

Description

Target Audience

Contents

Related in-house trainings

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GMP Awareness for Excipients Manufacturers

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Program

Results

Request an offer

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