Qualification and Validation workshop

Who Should Attend?

YOU MUST HAVE 6 months OF EXPERIENCE IN ENGINEERING, QUALITY ASSURANCE or PRODUCTION

Course Objective:

Upon completion of this course, you will be able to:

- Define Validation Master Plans

- Describe the Impact/Risk Assessment

- Prepare IQ/OQ/PQ Protocols

- Execute Protocols

- Write Protocol Summary Reports

- Describe the Quality Systems Necessary to Support Validation

Course Topics:

- Validation Life Cycle ( FDA/ ISPE)

- Qualification of HVAC System and Thermal Mapping

- Qualification of Autoclaves and pure steam

- Qualification of Ovens and Tunnels

- Qualification of Compressed air systems.

- Process Validation 

- Cleaning Validation

- Validation of Computerized Systems (CSV)

- Qualification of Water System 

Number of Sessions : 

9 Sessions

Instructor:

SPEAKER

Mohamed Saad Mohamed

Pharma Consultant, VALOR GM

                20+ years working in pharmaceutical field, working for different pharmaceutical drug manufacturers, VALOR GM.

SPEAKER

Dr. Ahmed Badran

Quality Assurance . validation- CSV supervisor

              15+ years Experience in Qualification  in pharmaceuticals

                   SPEAKER

 Osama Adel
Technical Manager

                  15+ years Experience in Qualification  in Qualification service provider

SPEAKER

Dr. Shady Nabil

                 Production Director

                  25+ years of Sterile Manufacturing experience 

SPEAKER

Mohamed El- Kkatieb 

                         Head Of Quality Assurance

             15+ years of quality system experience -Speaker at PHARMACONEX Conference  - ASQ Certified Six Sigma Black Belt