Request for in-house Seminar

NOBBIO Consulting is enjoying good reputation as an expert of GXP compliance in a global area, and thus many seminars and publications for the subjects relating to changes of GXP regulations and current practice, and/or inspection trend by FDA and EMA, have been released, upon request from publication/seminar companies (please refer to “About me” page). We therefore are pleased to provide in-house seminar as a part of in-house education or training to assist you to increase your employees’ compliance knowledge and operation skills to the global standard level, in addition to normal consulting activities involving product development or many types of projects. Further, we will help you to arrange for a s eminar by a foreign speaker utilizing our business network.

For your information an example of the topics and a brief list of the seminars provided so far by our staff and Nobbio Consulting LLC, but we could cooperate with you any topics that is not indicated below.

Example for the topics for Seminar

Global GMP inspection by the competent authorities for investigational medicinal products (appropriate Quality System as development stage upgrades)
Global GMP and Inspection by the competent authorities for API (bioproduct)
Global GMP and Inspection by the competent authorities for Sterile Pharmaceutical Products by Aseptic Processing
Comparison of PIC/S GMP and Japanese GMP and inspection procedure
Points to consider for development of bioproducts and CMC regulation
The latest inspection trend by FDA and EMA
Auditors qualification in comparison with the inspectors at authorities
How to cope with Data Integrity inspection
Requirements of new EMA/FDA Process Validation Guidance -Control Strategy and Continuous Process Verification for Bio API (Antibodies) and Freeze dry product
Compliance for revision of EU (PIC/S) GMP Annex 1 (Establishment of Contamination Control Strategy)

Presentation list (representative)

2008: “Revision of Japanese GMP for IMP”, PDA/FDA joint meeting in 2008 (Washington, D.C)

2011: Introduction of new Industry guidance 2011 for manufacture of sterile pharmaceutical products by aseptic processing”, GMP forum sponsored by Japan Pharmaceutical Manufacturing Association; “The Guidance for Industry 2011; Manufacture of Sterile Pharmaceutical Products by Aseptic Processing -(Revised version)”, PDA/FDA joint meeting in 2011 (Washington, D.C)

2012: “New Challenge and Opportunities of PIC/S in EU, USA and Asia”, the 25th Interphex Japan (June, 2012); “Comparison of new Industry guideline 2011 for manufacture of sterile pharmaceutical products by aseptic processing with PIC/S Annex-1”, Microorganism forum sponsored by Japan PDA

2015: “The status quo and prospected future of PIC/S GMP/GDP – Global Quality Management Strategy by strengthen audit function" The 28th time Interphex Japan (Tokyo and July, 2015)

2018: “Requirement under global GMP for clinical trial material and effective Quality Assurance System in drug development and commercial license filing stage”, Science and Technology

2020: “How to prepare FDA inspection for data integrity issue”, TH Planning

2021: Guidance for GMP for aseptic products (terminal sterilization vs aseptic manipulation), R&D Supporting Center; FDA Guidance for Process Validation (Control Strategy and Continuous Process Verification); How to apply lyophilized products, R&D Supporting Center; Introduction of EU GMP for Advanced Therapy Medicinal Products (Inspection Guidance issued by Swedish Medical Product Agency) Science and Technology

2022: How to cope with revision of EU (PIC/S) GMP Annex 1 (Implementation of Contamination Control Strategy) , CM Plus

2023: How to cope with revision of EU (PIC/S) GMP Annex 1 (Implementation of Contamination Control Strategy) , CM Plus