SNMMI Qualified Systems Personnel Training Program (QSPTP)

Overview

The manufacture of radiopharmaceuticals and the ongoing production of radiopharmaceuticals is dependent on skilled personnel cross-trained in several disciplines. There is a need to educate, train and develop individuals with a pharmacy or chemistry background in production and release of radiopharmaceuticals. The SNMMI Qualified Systems Personnel Training Program (QSPTP) has been developed to define the competencies of a Qualified Person in the release of manufactured radiopharmaceuticals. It is intended to provide experts in the field of radiopharmaceutical science guidance in program development.

The SNMMI Qualified Systems Personnel Training Program (QSPTP) will provide the theoretical knowledge and practical experience needed to assume responsibility for the small-scale manufacture, quality control and release of radiopharmaceuticals. Specific needs include cross-training in the principles and practice of radiopharmaceutical science; manufacturing and quality assurance of radiopharmaceuticals—both in the academic and commercial settings; synthesis and pharmaceutical formulation of radiopharmaceuticals especially from cyclotron-produced radionuclides; application of radiopharmaceuticals in biomedical research and clinical nuclear medicine; and compliance including all regulatory requirements associated with radiopharmaceutical manufacture and release.

Program Goals

The QSPTP will provide educational and experiential programming to prepare individuals to:

  1. Manufacture radiopharmaceuticals
  2. Comply with regulations associated with production and development
  3. Assume responsibility for small-scale radiopharmaceutical manufacturing
  4. Collaborate, advocate, and promote standards of practice in radiopharmaceutical production and development

Program Overview

Part One - Learning Modules
  • Quality Systems (Procedures and Operations: Basic concept, QA Management and Structure)
  • Pet Drugs - Current Good Manufacturing Practice (CGMP)
  • Overview of Part 211
  • Overview of Part 212 and 823
  • Historical Overview USP
  • Law Administration USP Chapters (797 and 825)
  • NDA and ANDA Submission
  • Reporting Requirements
  • IND submission
  • Contract Manufacturing
  • 21 CFR 212 Subpart C: Quality Assurance (212.20)
  • 21 CFR part 212 Subpart D: Facilities and Equipment (212.30)
  • 21 CFR Part 212, Subpart E: Control of Components, Containers and Closures (212.40)
  • 21 CRP Part 212 Subpart F: Production and Process Controls (212.50) and Subpart G: Laboratory Controls (212.60) PART 1
  • 21 CRP Part 212 Subpart F: Production and Process Controls (212.50) and Subpart G: Laboratory Controls (212.60) PART 2
  • 21 CRF Part 212 Subpart H: Finished Drug Product Controls and Acceptance
  • 21 CFR Part 212 Subpart I: Packaging and Labeling (212.80)& Subpart J: Distribution (212.90) Subpart K: Complaints (212.100) & Subpart L: Records (212.110)
  • Quality Assurance
  • Cyclotron and PET Chemistry Synthesis Modules; Maintenance and Calibration
  • Microbiology
Part Two - Learning Modules (expected launch date: Summer 2022)
  • Substrate Specific Radiopharmaceutical Localization
  • Substrate Non-Specific radiopharmaceutical Localization
  • Pharmacology of radiopharmaceuticals "Radiopharmacology" PART 1
  • Pharmacology of radiopharmaceuticals "Radiopharmacology" PART 2
  • Pharmacology of radiopharmaceuticals "Radiopharmacology" PART 3
  • Nuclear Physics and Instrumentation: Atomic Structure and Radioactive Decay
  • Nuclear Physics and Instrumentation: Interaction of Radiation with Matter and Radiation Detection
  • Nuclear Physics and Instrumentation: Nuclear Counting Statistics
  • Nuclear Physics and Instrumentation: Nuclear Counting Systems
  • Radiation Dosimetry for Radiopharmaceuticals
  • Basic Nuclear and Radiochemistry
  • Radionuclide Production - Reactors
  • Radionuclide Production - Cyclotrons
  • Radionuclide Production Radionuclide - Generators
  • Radionuclide Production Devices
  • Introduction to Radiopharmaceuticals
  • Radiochemical Syntheses - Automated
  • Non Metal Radionuclides General Concepts and 18F
  • Non Metal Radionuclides 11C, 13N, 15O, 124II
  • Non Meta SPECT Radionuclides, Imaging & Therapy
  • Radiometals - General concepts
  • Radiometals - Single Photon Radiometals Tc, In, other
  • Radiometals - Positron-Emitting radiometals
  • Radiometals - Therapeutic Radiometals
  • Quality Control Techniques - Visual, pH, Methods, TLC
  • Quality Control Techniques - HPLC
  • Quality Control Techniques - GC
  • Quality Control Techniques - Dose Calibrator and MCA
  • Quality Control Techniques - PET Quality Control & Analytic Methods Transfer
  • Quality Control of Radiopharmaceuticals

Part Three - Experiential Learning - FDA Manufacturing Sites (expected launch date: Late 2022)

Applicants will take part in an experiential learning program at a participating institution. Details coming soon.

Target Audience

PharmD, B.S. or M.S. Pharmacists or M.S. in Chemistry prior to beginning QP Program. Qualified for graduate studies. 

Fees:

The course fee includes all Part One and Part Two learning modules. No CE credit is available for this program.
There will be a separate fee for the Part Three Hands-on/Experiential Learning program.

  • SNMMI Members: $1,495 | Nonmembers: $2,195
  • Institutions (up to 5 personnel): $2,495


A certificate will be issued after completion of the program, and passing an exam administered by the American Board of the Society of Nuclear Medicine (ABSNM).