Fawzy Saad Hassan has over 10 years of experience as a consultant for pharmaceutical, biopharmaceutical, and vaccine projects. He has established quality assurance systems, developed validation master plans, conducted technology transfers, and provided GMP training. He is the executive manager of an international consultancy center and has experience working with companies like GSK, Novartis, Sanofi Aventis, and VACSERA.

1. Fawzy Saad Hassan
Fawzy Saad Hassan, MSc
Pharma & Biopharma Consultant
(+2) 02 23685337 Office
(+2) 01112340250 Cell
fawzihassa@hotmail.com
Contents:
1- Objective
2- Summary of:
A- Established Projects
B- Training Activates
3- Highlight of qualifications
4- Professional experience
5- Educational qualifications
6- Additional training
7- References
Resume Page 1 of 17

2. Fawzy Saad Hassan
To demonstrate my qualification and experience in pharmaceuticals and biopharmaceuticals
projects planning, development, execution and management
A - Established Projects
Summary of last 10 Years
Project Location Start Our Responsibility
EGPI Egypt 2015 - Developing and managing the implementation of
project Quality Assurance and GMP upgrading of
the company manufacturing facility to match the
International Standards and Guidelines including
process validation, cleaning validation and
holding time validation
Company Egypt 2015 - Reviewing the conceptual, basic and detailed
design of a mega project for pharmaceuticals and
biopharmaceuticals including the validation
master plan VMP
VACSERA Egypt 2015 - Developing the technical feasibility studies and
coordinating the technology transfer projects for
one of VACSERA affiliated companies in the
following: Plasma Collection, Blood Fractionation,
LVP manufacturing
United
Company
Egypt 2014 - Developing and managing the implementation of
Quality Assurance System matching the new
European Good Distribution Practice EU GDP
and related training activities
Capital Group
Pharma
Egypt 2012 - Developing GMP conceptual & basic Design
- Developing the technical specifications URSs
- Project Management
Tri-M Egypt 2011 - Developing GMP conceptual & basic Design
2- Summary of:
1- Objective
Resume Page 2 of 17

3. Fawzy Saad Hassan
Al Awael
Pharma
Egypt 2011 - Developing GMP conceptual & basic Design
- Developing the technical specifications URSs
- Tender documents & Quotation evaluation
- Supervising the detailed design
- Project Management
National
Regulatory
Authority
Egypt 2011 - Developing and managing the implementation of
the Validation Master Plan VMP for National
Regulatory Authority (NRA) Laboratories for
WHO qualification
Atlas Pharma Maurita-
nia
2010 - Communications for technology transfer (Oral,
Injectables and LVP dosage forms) with:
Bio-Cure Pharma, South Korea - Kolon, South
Korea - JPM, Jordan
- Developing Conceptual & Basic Design
- Support in developing contracts
Pharmaceutical
Solution
Technology PST
KSA 2010 - GMP Audit & GAP Analysis Report
- Developing Validation Master Plan VMP
- Developing and execution the qualification and
validation protocols for process validation and
cleaning validation
- Developing QA system SOPs and record forms
Sham Pharma Syria 2009 - Developing the Technical Feasibility Study for
LVP project
- Communications with technology transfer
provider:
Fresenius, Germany - BioCure Pharma, South
Korea - Claris, India - Holdi-Pharma, Egypt -
BDPL, India
Foras
International
KSA 2009 - Developing the technical feasibility study for
constructing insulin production facility
Rafik Saydam
(NIH)
Turkey 2009 - GMP auditing and GAP analysis report for
National Public Health Agency, Ankara, Turkey
Global Bio KSA 2008 - Developing the GMP conceptual design for
Insulin formulation & filling facility
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4. Fawzy Saad Hassan
Atlas Pharma Maurita
nia
2008 - Developing technical feasibility study for
constructing pharmaceutical manufacturing
facility to cover Mauritania Mali and Senegal
ARABIO KSA 2006 - Member of technical committee for:
Reviewing the conceptual design developed by
Pharma Plan, Germany
- Reviewing the technical specification developed
by ACDEMA, Jordan (Project partner)
- Negotiating Technology transfer with technology
providers:
GSK – Novartis - Sanofi Aventis - BioPharma,
Indonesia - LG, Korea - Shantha Biotechnics,
India
- Developing the Project Validation Master Plan
-Reviewing/Approval supplier IQ & OQ protocols
- Establishment of quality assurance system
documentation, SOP and records
VACSERA Egypt 2003 Member of a technical committee for:
- Project design with Pharma Plan, Germany -
Steril, Italy - Shepard, UK
- Technology transfer negotiation with Smith
Kline, Belgium
- Following up 2 projects designed by Steril, Italy
(pharmaceutical part of Foster willer, USA
- Reviewing/Approval supplier IQ, IQ protocols
- Developing and execution of PQ protocols
- Developing and execution the cleaning validation
protocols
- Establishment of QMS documentation
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5. Fawzy Saad Hassan
B- Summary of last Training Activities
I have provided the following training courses in Egypt and abroad:
Company - Location Training Course Duration
1- BioLinx, Egypt Pharmacovigilance 10 Days
2- NODCAR Test Method Validation 3 Days
3- Group of Professionals Process Validation and Cleaning Validation 5 Days
4- Medpharma, Sharjah, Emirates Good Manufacturing Practice GMP 3 Days/ 2Times
5- Pharma Solutions Industries, Jeddah, KSA Training the GMP Trainers 3 Days
6- National Laboratories. Cairo, Egypt Process Validation and Cleaning Validation 3 Days
7- Sigmatech. 6th
October City, Egypt Sterilization Validation 3 Days
8- Egyptian Group Pharma. Al Obour, Egypt Good Manufacturing Practice 3 D/ 3 Times
9- Egyphar. Al Obour City, Egypt Good Manufacturing Practice 3 D/ 5 Times
10- Egyphar. Al Obour City, Egypt Process Validation and Cleaning Validation 3 D / 2Times
11- BIOVAC & BIOLINX. Cairo, Egypt GMP /GDP 2 D/ 2 Times
12- BIOVAX & BIOLINX. Cairo, Egypt GDP and Pharmacovigilance 1 Day
13- BIOVAC & BIOLINX. Cairo, Egypt Good Storage Practice GSP 1 Day
14- Event. Cairo, Egypt Pharma & Biopharma QA 3 Days
15- Web Seminar hosted by Novatek, Canada Environmental Monitoring 3 Hours
16- Laboratories of Environment (MOE) ISO 17025 2D/4 times
17- ARABIO.Saudi Arabia Quality Assurance, GMP Resident
18- Diagsera. Cairo, Egypt WHO for Ex. Quality Scheme 2 Days
19- Novopharma. Tashkent, Uzbekistan Good Manufacturing Practice 3 Days
20- Novopharma. Tashkent, Uzbekistan Process Validation 2 Days
21- Novopharma. Tashkent, Uzbekistan Cleaning Validation 2 Days
22- VACSERA. Egypt Facility, Equipment Q / V Resident
23- VACSERA. Egypt Effective Quality Assurance Resident
24- VACSERA. Egypt Good Manufacturing Practice Resident
Resume Page 5 of 17

6. Fawzy Saad Hassan
3- Highlight of qualifications
Executive Manager of International Consultancy Center (I.C.C), Cairo for Pharmaceuticals,
Biopharmaceuticals and Vaccines Projects Consultation
Consultant for Egyptian Company for Blood Services (Egy Blood), one of VACSERA
Affiliated Companies
Consultant for Egyptian Group for Pharmaceutical Industries (EGPI) for upgrading quality
assurance system and GMP compliance
Consultant for Foras International Investment, Jeddah, KSA for Pharmaceuticals
Biopharmaceuticals and Vaccines Projects in Organization of Islamic Cooperation (OIC)
Member Countries
Representative of Shantha Biotechnics part of Sanofi Avantis, and it is a WHO qualified
manufacturer supplying Vaccines to the United Nations Programs)
Professional experience in the negotiation of technology transfer projects with multi-national
companies and main players in Pharmaceuticals and Biopharmaceuticals like GSK, Novartis,
Sanofi Aventis, etc
Excellent experience in establishing policies, plans and procedures for Pharmaceuticals,
Biopharmaceuticals and Vaccines projects establishment
Excellent knowledge with US FDA, EU and WHO regulation and guidelines controlling the
medicinal products manufacturing and distribution
Experience in working within a highly regulated environment through attending full time
campus based, many training courses and conferences in United Stats, Canada and Europe
Resume Page 6 of 17

7. Fawzy Saad Hassan
Professional experience in auditing and reviewing the manufacturing plant design and related
facilities for GMP compliance, generating gap analysis report and improvement plans for
Pharma, Biopharma and Vaccines industries
Developing/implementing and follow up an effective and validated quality assurance
documentation system including procedure for change control, OOS and deviation reporting
Preparation and qualifying the manufacturing facilities for regulatory inspection, GMP
certification and ISO accreditation
Experience in providing training on quality assurance, quality control, good practices
(cGMP, GSP, GDP,…GXP), equipment/facility qualification, process/cleaning validation and
ISO standards
Experience in developing the technical Feasibility Studies for Pharmaceuticals &
Biopharmaceuticals and Vaccines Projects
Experience in projects planning and execution follow up for both revamping and new projects
Experience in developing/reviewing the conceptual and basic design of the new project
including but not limited to material/personnel flow, zoning concept and the environmental
parameters of sterile/clean area.
Experience in developing/supervising the implementation of the validation master plan
(VMP) of the Pharmaceuticals, Biopharmaceuticals and Vaccines production facilities and the
related quality control facilities
Experience in developing and supervising the implementation of the Validation Master Plan
(VMP) of the specific production processes and cleaning processes of Pharmaceutical,
Biopharmaceutical and Vaccines production facilities
Resume Page 7 of 17

8. Fawzy Saad Hassan
Experience in developing/reviewing and supervising the implementation of qualification &
validation protocols (PQ & PV) of equipment, systems and processes for Pharmaceuticals &
Biopharmaceuticals production facilities
Experience in the implementation of Quality Systems related to FDA-CFR, European and
WHO in good practices; GMP, GLP, GSP and ISO standards
Experience in developing and implementation of effective quality assurance program for
production plants and testing facilities to mach the regulatory expectations
Experience in reviewing and approval of installation/operational qualification protocols (IQ,
OQ) of production equipment and process utilities provided by machine/equipment suppliers
4- Professional Experience:
Jan, 2008 until now
Executive Manager of International Consultancy Center ICC, Cairo
Executive managing the contracted projects in behalf of ICC which include but not limited to
the following:
- VACSERA, EgyBlood Consultation
- Egyptian Group for Pharmaceutical Industries EGPI, Al Obour City, Egypt
- Tebah for Pharmaceutical Industries, 10th
of Ramadan City, Egypt
- Capital Group for Pharmaceuticals Industries, Sadat City, Egypt
- Al Awael Pharmaceutical Company, Sadat City, Egypt
- Tri-M medical, Badr City, Egypt
- Atlas Pharma, Nouakchott, Mauritania
- PST for IV, Riyadh Industrial City, Saudi Arabia
- Technical training center, Sanaa, Yemen
- LVP injectables, Damascus, Syria
- Formulation and filling facility, Saudi Arabia
Resume Page 8 of 17

9. Fawzy Saad Hassan
Upgrading the quality system of the Bio Egypt Company to match the European GDP
Training for Biolinx Company for GPVP
Providing training course on Training the GMP for all employees within the Medpharma
Company in United Emirates
Providing training course on Training the GMP trainer for the head of sectors and department
in Pharmaceutical Solutions Industries PSI, Jeddah, Saudi Arabia
Consultant for Foras International Investment, Jeddah, KSA for Pharmaceuticals
Biopharmaceuticals and Vaccines projects in Organization of Islamic Cooperation (OIC)
member countries
Representative of Shantha Biotechnics in Egypt during 2009, 2010, 2011
Shantha Biotechnics is a part of Sanofi Aventis and it is a WHO qualified manufacturer of
Vaccines and Biotechnology products, supplying Vaccines to the United Nations programs.
The Company located in Hyderabad, India
Providing a training course on process validation and test method validation, the course is
organized by Egyptian Society of Quality ESQ, Cairo
Providing a training courses on sterilization validation for Sigmatech (Pharmaceutical
Production Company located in the industrial zone, 6th of October City, Egypt)
Providing a training courses on cGMP for Egyptian Group EGP (Pharmaceutical Production
Company located in the industrial zone, Al-Obor City, Egypt)
Providing a training GMP Courses for Egyphar (Pharmaceutical Production Company located
in 10th of Ramadan city), the program done in 5 courses, financially supported by European
Fund in collaboration with the Industrial Modernization Center IMC, Cairo
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10. Fawzy Saad Hassan
Providing a training courses on Process Validation and Cleaning Validation for Egyphar
(Pharmaceutical Production Company located in 10th of Ramadan city), the program done in
2 courses, financially supported by European Fund in collaboration with the Industrial
Modernization Center IMC, Cairo
Execution of a training event in collaboration with Academy of Applied Pharmaceutical
Science AAPS, Canada and 6th October University on cleaning validation
Execution of a training event in Dar Al Moshah on Pharmaceuticals and Biopharmaceuticals
production, quality and control
Providing a Web Seminar training in collaboration with Novatek International, Canada on
Environmental monitoring in pharmaceutical and biopharmaceutical industries for the
pharmaceutical manufacturers in Egypt, Saudi Arabia and Jordan
Sep, 2007- Dec, 2007
Implementation of 21CRR – 11 compliant quality assurance software programs to provide
solutions for quality problems and to facilitate the international certifications process for
Pharmaceuticals, Biopharmaceuticals and Vaccines manufacturers, the implementation of
software ware accompanied by providing training on 21 CFR parts 210 & 211 cGMP
The software developed by Novatek International, Montréal, Canada
The clients: Delta Pharma, Amoun, Global Nabi, Orkedia, Adwia, .etc
Sept, 2006 – Sep,2007
Quality Assurance Manager for ARABIO, KSA. ARABIO is a brand new, a state of the art
cGMP compliant facility designed by Pharma-Plan Germany
Attending interactive meetings for reviewing the conceptual and basic design of the facility in
collaboration with Pharma Plan Company, Germany
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11. Fawzy Saad Hassan
Participating in the Negotiation of the know-how transfer meeting with GSk, Novartis Sanofi,
and Biopharma
Reviewing the technical URSs of the machine equipments and systems and qualifying the
suppliers in collaboration with highly qualified team from ACDIMA, Jordan
Writing the project Validation Master Plan VMP which revised and approved by Validation
Technologies Inc (VTI) USA
Providing training for ARABIO staff on Quality assurance, GMP, qualification and validation
Providing the technical support and attending the meetings during the discussion with the
technology know how provider such as GSK, Novartis, Biopharam, .etc
Reviewing and approval of the IQ and OQ of the machine, equipment and systems provided
by suppliers such as Getting for autoclaves, Pharmatch for water system, MRC for clean
room, ..etc
Jan-Aug, 2006
Manager of the New projects for VACSERA in Egypt and abroad.
Establishing and follow up a team for conceptual and basic design of sterile media
production facility and diagnostic reagents production facility.
Establishing and follow up a team to qualify (DIAGSERA) quality control laboratories for
accreditation (ISO 17025) to be recognized by WHO for external quality assurance scheme.
Providing the related training for establishing ISO standard No. 17025 and the WHO
guidelines for implementing external quality assurance scheme
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12. Fawzy Saad Hassan
Preparation and qualifying 3 laboratories belonging to the Ministry of Environment in Tanta,
Mansoura and Sowes governorates for ISO 17025 compliance and accreditation
Represent VACSERA in the technical committee for the company ARABIO, KSA, the
project include two production lines for sterile formulation, filling and packaging of
biological products.
The involvement include the conceptual & basic design, facility & equipment technical
specifications, evaluation of suppliers quotations and validation master plan
Perform quality assessment, GMP auditing and generating the gap analysis report for
NOVAPHARM Company
Novapharm is a pharmaceutical production company located in Tashkent, Uzbekistan for
preparation and filling of pharmaceuticals liquid and powder (two physically segregated
facilities)
Developing GMP compliant conceptual design for a new vaccines production facility
including fermentation facilities, formulation and filling line; for NOVAPHARM, Tashkent,
Uzbekistan
Providing training on GMP, process validation and cleaning validation for the
NOVOPHARM Company staff, Tashkent, Uzbekistan
2003 - 2005
Senior quality assurance manager for the Holding Company for Biological Products and
Vaccines VACSERA, Egypt
Implementation of ISO: 9001, 14001, 17025 in VACSERA.
Providing the training required for the implementation of ISO: 9001, 14001, 17025 for
VACSERA Staff
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13. Fawzy Saad Hassan
Perform qualification of new sterile vaccines production facility containing formulation area
and two filling lines, one for vials and another for plastic tube filling to produce sterile
products, VACSERA.
Providing the training on qualification and validation of the aseptic manufacturing facility
and aseptic processes for the team involved in the process.
Establishment of fully qualified aseptic production facility (IQ, OQ, PQ, PV and ClV)
contain formulation area and vial filling area to produce sterile biological and vaccines
products, VACSERA, licensed by GSK.
Providing the training on IQ, OQ, PQ, PV and CLV for the team involved in the process.
Coordinate the technology transfer projects for VCSERA-GSK.
GSK is a well known multinational company and it is one of the main players in vaccines
manufacturing
Providing training for internal and external candidates in the area of qualification/validation
and quality assurance, regulations and vaccines manufacturing guidelines
Developing the engineering conceptual design of DTP vaccines production facility for
WHO, GMP compliance
Developing the engineering conceptual design for TT vaccine production facility for WHO,
GMP compliance
Sharing in the conferences and work shops organized by universities and non governmental
organizations (NGOs).
2000 - 2002
Participating in the quality assurance department in Aventis, Toronto, CANADA
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14. Fawzy Saad Hassan
Attending training course on change control management, the course organized by Aventis
Aventis is a well known multinational company and it is one of the main players in
Pharmaceutical and Biopharmaceutical manufacturing
Full time training, campus based on QA/QC of Pharmaceuticals and Biopharmaceutical for
15 months in Toronto Institute for Pharmaceutical Technology TIPT, Toronto, CANADA
Toronto Institute for Pharmaceutical Technology TIPT, Toronto, CANADA is one of the
leading institutes in North America providing Diploma in Pharmaceutical and
Biopharmaceutical's Quality Assurance and Quality Control
Training on method development, method validation and process validation
Application of statistics in method development, method validation, process validation and
Cleaning validation.
Performing different types of auditing for the quality systems, production facilities, quality
control laboratories and testing methods
1990-2000
Representing VACSERA in its new projects with Sterl Company for developing conceptual,
basic and detailed design of the following projects:
Viral vaccine formulation and filling facility, Bacterial vaccine project fermentation,
purification, formulation and filling, sera preparation, purification and final bulk preparation
Steril Company is Italian pharmaceutical engineering company affiliate to Foster wheeler
USA
Inspection of incoming materials, imported bulk and final products of vaccines and
biological products
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15. Fawzy Saad Hassan
Providing training scions on the inspection of in-coming raw materials and bulk vaccines
and biological products for the quality assurance personnel
Inspection of production, quality control and storage facilities for GMP, GLP, GSP
compliance
Participating in the activities of the validation team to qualify a new production facility,
writing and approval a lot of qualification protocols.
Participating in a team for performing the quality auditing, generating reports and following
up the corrective actions.
Reviewing the batch production records as a format for approval and as a record for
compliance
Participating in the supply chain for the production activities
Participating in the production activities for bacterial vaccine
Participating in the production activities for viral vaccines
Participating in the activities of the sterile filing, line clearance and cleaning process
5- Educational Qualifications
Diploma in Quality Assurance and quality control, Toronto Institute for Pharmaceutical
Technology, TIPT, Toronto, CANADA, 2002
Master Degree in Biochemistry, Cairo University, 2000
BSc (Chemistry), Cairo University, 1985
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16. Fawzy Saad Hassan
6- Additional Training
Certified Quality Manager Program (CQM), the American University in Cairo, (AUC),
Institute of Quality Management, 2003
Facility Qualification Course, Dublin, IRELAND 2003
Training on (Change Control Program Auditor Training Course), March, 2002. Organized
by Aventis, Toronto,, CANADA
Training program on (training the trainers), March, 2002, organized by Aventis, Toronto,
CANADA
Training program on (Facility Qualification), Nov, 2003, organized by Institute of
Validation Technology (IVT), Dublin, IRELAND
Training program on (Design and Implementation of a Compliant Stability program), Nov,
2003, organized by International Pharmaceutical Academy (IPA), CANADA
Conference on (Exposition 2002 for Pharmaceuticals and Biopharmaceuticals), Sep, 2002,
organized by International Pharmaceutical Academy (IPA), Toronto, CANADA
Change Control Program Auditor Training Course, March, 2002. The course organized by
Aventis Pasture Connaught Campus, Toronto, CANADA
Project on developing and execution of cleaning validation protocol for tablets comprising
machine to demonstrate the efficiency of placebo method as a tool in cleaning validation,
TIPT, Toronto, CANADA
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17. Page 17 of 17
Fawzy Saad Hassan
Training program on “Secrets of competency testing: Writing the CPHQ Exam” Workshop,
Sept, 2000. Sponsored by ESQUA in collaboration with Healthcare Quality Certification
Board of the National Association For Health Care Quality. Cairo, EGYPT.
Fifth Annual conference on Validation, Nov, 1999, organized by Institute of Validation
Technology (IVT), New Jersey, USA
Training program on National Regulatory Authority (NRA) functions, Feb 1999. Executed
by WHO Experts, Cairo, EGYPT
Intensive 7 days Training Program on: VPM, WFI validation, Validation of packaging,
sampling technique, military standard, batch record review, cleaning policy, media fill,
environmental monitoring, sterile gowning validation, HVAC validation, cold rooms
validation, aseptic filling/lyophilizer validation, and overview on vaccines manufacturing.
1999, Sponsored by SmithKline Beecham (Now it is a part of GSK) Rixensart, BELGIUM.
Certification of Recognition on Biological Products for the 21st Century, (Future of Serum
and Vaccines Industries), 1999, the conference sponsored by Cairo University, EGYPT
Training course on “Environmental and Health Effects of Pesticide Exposure”, Oct, 1996.
Faculty of Medicine, Cairo University, EGYPT
Attending a lot of conference inside Egypt on quality management, quality assurance and
qualification/validation
7- References
References are available upon request, and the following are some of certificates:
Resume