cGMP TRAINING / ACTIONS


  •  

  • PBE's cGMP TRAINING / ACTIONS TOPICS:

  1. Integrated Biotechnolgy & Pharmaceutical projects management
  2. RAPA : A new Approach of the Risk Analysis Management & Assessment according to FDA, ICH Q9, ASTM 2500, ISPE vol5, FMEA, AMDEC
  3. cGMP Sanitary Design for Clean Utilities Units (production, storage tank, distribution loop) of PW, WFI, Pure Steam, Process Compressed Air (ISO-8573).  From cGMP Design, Commissioning to Validation.  Top 10 Errors to Avoid
  4. HVAC & Cleanroom design for pharmaceutical facilities involing High Potent compounds (1@5), Explosive & flammable solvents (ATEX 1@3), and Biological containment mediums BSL1@4
  5. cGMP Aseptic / Sterile manufacturing Process Practices including HVAC & cGMP compliance sanitary design meeting ASME-BPE standard
  6. Lyophilization Process - Fundamenta - Formulation - Production and Validation
  7. New Update and Application of Process Validation Guides according FDA 2011 and EMA 2014
  8. Clean In Place CIP / COP Technologies From cGMP Design, Commissioning to Validation.  Top 10 Errors to Avoid
  9. Cleaning Validation - A case study of new Process Validation guidelines
  10. Top 10 Golden Rules to successed FDA, EMA, WHO, PIC & PIC/s Inspections
  11. Sterilization Technologies From cGMP Design, Commissioning to Validation.  Top 10 Errors to Avoid
  12. APR (Annual Product Review)
  13. Bioprocessing Technologies (Upstream, Downstream, Purification, ... ) from cGMP Design, Commissioning to Validation.  Top 10 Errors to Avoid
  14. VNV Contaminants origin and appropriate new prevention techonologies & removal
  15. Integrated pharmaceutical project management & Engineering design & PM documents development: URS, FDS, technical specifications, risk analysis assessment, QA plan.
  • c-GMP Online Training:

www.mvitraining.com

  • c-GMP & Risk Analysis Online training:

Risk Analysis in Pharmaceutical Manufacturing A Regulatory Overview (Steven S. Kuwahara, Ph.D.):

https://www.youtube.com/watch?v=OTLmvey-Zvc


  • ASEPTIC & STERIL MANUFACTURING FACILITIES :

Aseptic Gowning for the Cleanroom : https://www.youtube.com/watch?v=uvhaPu1-fdE



  • Cleanrooms & Aseptic environment errors assessment Training :

https://youtu.be/Ks1Tlo0pViA


  • Understanding Sterile Production:

https://www.youtube.com/embed/MRVwZuCkC_s

- www.mvitraining.com

  • LAB SAFETY :

- Lesson 1: Proper Dress and PPE :   https://youtu.be/GjAD83B4JaY

- Lesson 2: Safety Equipment :   https://youtu.be/IiHEYtnKfF0

- Lesson 4: Chemical Hazards:   https://youtu.be/8queMM7VVfw

;

http://www.youtube.com/medeffect

https://www.connect-upstream.com/speed-to-clinic/?utm_medium=stam&utm_source=inxmail&utm_campaign=connect%20upstream%20II%20North%20America&utm_content=us%20060716


Pharma Bio Expert, votre garantie en conformité réglementaire de vos projets BioPharmaceutiques