Live Webinar | From 2nd October to 20th November | h. 15.00 to 17.30
THE EIPG – EUROPEAN INDUSTRIAL PHARMACISTS GROUP – organizes a professional training course on the production of sterile products.
The course is structured in 8 modules.
Module 1 | 2nd October | Walid El-Azab & Marta Rodriguez
Annex 1 Chapters and Paragraphs considered:
2. Principle
General principles as applied to the manufacture of sterile products – CCS (2.1 – 2.7)
3. Pharmaceutical Quality System (PQS)
Highlights the specific requirements of the PQS when applied to sterile products (3.1 – 3.2)
7. Personnel
Guidance on the requirements for specific training, knowledge and skills. Also gives guidance regarding the qualification of personnel. (7.1 – 7.18)
Module 2 | 9th October | Tracy Moore
Annex 1 Chapters and Paragraphs considered:
4. Premises
Module 3 | 16th October | Mark Thompson
Annex 1 Chapters and Paragraphs considered:
5. Equipment
General guidance on the design and operation of equipment. (5.1 – 5.9)
6. Utilities
Guidance regarding the special requirements of utilities such as water, gas and vacuum. (6.1 – 6.22)
Module 4 | 23rd October | Walid El-Azab & Stan O’Neil
Annex 1 Chapters and Paragraphs considered:
8. Production and specific technologies (I)
Module 5 | 30th October | Stan O’Neil
Annex 1 Chapters and Paragraphs considered:
8. Production and specific technologies (II)
Module 6 | 6th November | Tracy Moore
Annex 1 Chapters and Paragraphs considered:
8. Production and specific technologies (III)
Module 7 | 13th November| Stan O’Neil
Annex 1 Chapters and Paragraphs considered:
9. Environmental and process monitoring (I)
Module 8 | 20th November | Patrizia Muscas & Francesco Boschi
Annex 1 Chapters and Paragraphs considered:
9. Environmental and process monitoring (II)
Aseptic process simulation (9.32 – 9.49)
10. Quality Control
Guidance on some of the specific Quality Control requirements relating to sterile products (10.1 – 10.11)
FRANCESCO BOSCHI
Sr. Manager Technical Services – Global Microbiology and Aseptic Support Team (MAS) Pfizer
ITALY
WALID EL-AZAB
Co-founder & Managing Director QP Pro Services
Extensive expertise in GMP of sterile products
BELGIUM
TRACY MOORE
Fonder and CEO at TM Pharma Group Ltd and former MHRA Expert EU GMDP Inspector
UK
PATRIZIA MUSCAS
Sterility Assurance Director, Global TS.MS Eli Lilly and Company
ITALY
STEN O’NEIL
Managing Director The Compliance Group Assistant Professor Trinity College Dublin
Honorary Associate Professor Royal College of Surgeons In Ireland
IRELAND
MARTA RODRIGUEZ
Quality Assurance Leti
AEFI expert in Quality Control, Quality Assurance and Manufacturing
SPAIN
MARK THOMPSON
Managing Director MTL Projects Ltd
Expert in pharmaceutical engineering, especially in sterile product manufacturing
UK
This course will allow you to achieve the following learning outcomes:
Industrial pharmacists and other professionals working in the pharmaceutical sector who are interested in the manufacture of sterile medicinal products
If you are EIPG member, you can request your discount coupon here.
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