日本語 / English

NOBBIO Consulting LLC

Tel
:
043-286-1557
Mail
:
tateishinbo@nobbio.net

Request for in-house Seminar

NOBBIO Consulting is enjoying good reputation as an expert of GXP compliance, and thus many seminars and publications for the subjects relating GXP regulations and inspections, have been released, upon request from publication/seminar companies. We therefore are pleased to provide in-house seminar as a part of internal education or training to assist to increase your compliance knowledge and skills to a global level, separately form normal consulting activities involving product development or many types of projects. Further, we will help you to arrange for a seminar by a foreign speaker utilizing our business network.

Example for Seminar

  • Global GMP and Inspection by the competent authorities for API (bioproduct)
  • Global GMP and Insection 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 prodcut

List of Seminar and Lecture (Major only)

2008
"Revision of GMP regulation for clinical trial medicine in Japan"-PDA/FDA joint meeting 2008 (Washington, D.C)
2011
"Revised “Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing”, Notification on April 20, 2011, by the Ministry of Health, Labor and Welfare, Medicine Food and Narcotics compliance bureau office" -PDA/FDA joint meeting 2011 (Washington, D.C)
"Revise of Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing", GMP Forum sponsored by Federation of Pharmaceutical Manufacturers' Associations of Japan (Tokyo)
2012
"Comparison between a Guidance on the Manufacture by Aseptic Processing (revised in 2011) and PIC/S GMP Annex-1", Microorganism Symposium sponsored by PDA Japan (Tokyo)
"The latest trend and a potential problem of the PIC/S activity- Europe-America and Asia (ASEAN and Japan)" The 25th time Interphex Japan (Tokyo)
"Influence and potential problem for PIC/S member by Japanese authority " GMP forum sponsored by Tochigi Prefecture government (Utsunomiya)
2015
"The status quo and future prospect of PIC/S GMP/GDP – Global Quality Management Strategy by strengthen audit function" The 28th time Interphex Japan (Tokyo)
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 cope with FDA inspection for Data Integrity", TH Planning
"The requirements of new EMA/FDA Process Validation Guidance -Control Strategy and Continuous Process Verification for Bio API"
"Guidance for comprehensive GMP of aseptic products" R&D Support Center
2021
"The requirement of new EMA/FDA Process validation Guidance -Control Strategy and Continuous Process verification for lyophilization Process" R&D Support Center
"How to cope with EMA GMP inspection for Advanced Therapy Medicinal Products" Science&Technology