ANNEX 1 CHAPTER AND TOPICS | 8 TRAINING WEBINARS

Course Program

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

• General guidance for premises design and qualification:
• Barrier Technology Isolators and RABS (4.1 – 4.22)
• Cleanroom and clean air equipment qualification (4.23 – 4.32)
• Disinfection of cleanrooms (4.33 – 4.36)

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)

•  Terminally sterilized products (8.1 – 8.6)
•  Sterilization (8.34 – 8.49)
• Sterilization by heat and moist heat sterilization (8.50 – 8.65)
• Dry heat sterilization (8.66 – 8.70)
• Sterilization by radiation and with ethylene oxide (8.71 – 8.78)

Module 5 | 30th October | Stan O’Neil 

Annex 1 Chapters and Paragraphs considered:

8. Production and specific technologies (II)

• Aseptic preparation and processing (8.7 – 8.18)
• Finishing of sterile products (8.20 – 8.33)
• Filter sterilization (8.79 – 8.95)

Module 6 | 6th November | Tracy Moore

Annex 1 Chapters and Paragraphs considered:

8. Production and specific technologies (III)

• Form-Fill-Seal and Blow-Fill-Seal (8.96 – 8.120)
• Lyophilization (8.121 – 8.126)
• Closed systems (8.127 – 8.130)
• Single use systems (8.131 – 8.139)

Module 7 | 13th November| Stan O’Neil 

Annex 1 Chapters and Paragraphs considered:

9. Environmental and process monitoring (I)

• General (9.1 – 9.13)
• Environmental monitoring – total particle (9.14 – 9.21)
• Environmental and personnel monitoring (9.22 – 9.31)

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)

Teachers

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
Quality Control & Manufacturing Expert in AEFI SPAIN

MARK THOMPSON
Managing Director MTL Projects Ltd
Expert in pharmaceutical engineering, especially in sterile product manufacturing
UK

Why choose our course?

This course will allow you to achieve the following learning outcomes:

• To understand thoroughly the requirements of Annex 1
• To be guided in the interpretation of critical requirements
• To learn how to implement the requirements in terms of equipment, procedures, and training, with examples

Who's It for?

Industrial pharmacists and other professionals working in the pharmaceutical sector who are interested in the manufacture of sterile medicinal products

EIPG Member

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