Course Description
PIPD diploma program, is a diverse Quality Management System training program that gives enrolled students a comprehensive introduction to the various skills required in different areas related to pharmaceutical industry and GMP compliance , and throughout its supply chain. This includes research and development , regulatory , procurement and storage of the raw materials , manufacturing , testing, release , storage and supply of finished products.
Certification
Certificates will be issued upon successful completion of the program from the Jordan University of Science and Technology, Jordan (JUST). The PIPD diploma certificate will be accredited by The Ministry of Higher Education in Jordan.
This Diploma is not intended to obtain academic degree and the training hours will not be accredited as credit hours for other academic programs.
Learning Outcomes
Curriculum-Modules contents:
MODULE 1: REGULATORS TO CGMP IN PHARMACEUTICALS MANUFACTURING
FDA
Europe
WHO
PICS
ICH
MODULE 2: DRUG PRODUCT DEVELOPMENT
Pre-formulation studies
API sourcing and Supplier qualification
DMF evaluation
Formulation studies
Quality By design (QBD)
Analytical methods development, validation and transfer
Accelerated stability studies
Shelf life evaluation
Setting Specification for raw material, intermediate product and finished drug product
Bio-batch and scaling up activities
Post approval changes
MODULE 3: QUALITY CONTROL
Good laboratory practices
Quality control labs design
Raw material testing
Finished product testing
Long term and ongoing stability studies
Out Of Specifications (OOS) and Out Of Trends (OOT) handling
Reference standards and working standards
Retained samples
Microbiology testing
Testing Instruments qualifications and calibration
Weighing and balances
Purified water testing
QC testing reporting
IPC testing
Sampling
Materials and products testing and release
LIMS
Data Integrity
MODULE 4: QUALITY ASSURANCE SYSTEM
Quality management system
Documentation and document control
Internal audits
Corrective /Preventive actions
Deviation handling
Product Quality Review
Management review
Quality risk management
Change control
Batch record review and batch release
Complaints
Product recall
External inspections
Technical agreements and suppliers qualification and approval
Validation Master Plan
Site master file
Quality Manual
MODULE 5: ENGINEERING (FACILITY, EQUIPMENT AND UTILITIES REQUIREMENTS)
Manufacturing facility Design
HVAC system
Water treatment system
Utilities for pharma industry
Corrective maintenance
Preventive maintenance
Clean rooms qualification
Equipment qualification
Utilities qualification
Building management system (BMS)
Utilities and equipment Calibration
Computer system validation and verification
MODULE 6: PRODUCTION OPERATIONS AND PROCESS CONTROL
Manufacturing
Packaging
Batch record preparation
Gowning, Sanitation and hygiene
Process charts control and production in process testing
Contract manufacturing and packaging
Environmental monitoring and control
Process validation
Cleaning Validation
MODULE 7: PERSONNEL AND TRAINING REQUIREMENTS
Personnel qualification and training
Qualified person
Personnel hygiene monitoring
Personnel health check
MODULE 8: REGULATORY
CTD (Common Technical Document) and eCTD
Regulatory requirements for products registration in different countries
Pharmacovigilance
Patents and patents regulation laws
MODULE 9: PHARMACEUTICALS STORAGE AND DISTRIBUTION REQUIREMENTS
Raw materials and finished products stores design
Good storage and distribution practices
ERP systems
Products distribution
Pest and rodents control
Environmental monitoring and control
Thermal mapping and qualification of the stores and the distribution vehicles
Reject handling and disposal
Inventory check
Instructor
Dr Bashar M Altaani
PHD
- Holds a PhD degree in Industrial and Physical Pharmacy from Purdue University in the USA
- Currently, He is an Associate Professor in Department of Pharmaceutical Technology in Jordan University of Science and Technology.
- He teaches pharmaceutical manufacturing and pharmaceutical quality assurance courses in the school of pharmacy.
- He has held several workshops for topics related to pharmaceutical manufacturing and performed several projects with Pharmaceutical industry.
Dr Nadia ARA Ghazal
PhD
- Holds a PhD degree in Pharmaceutical Technology and master degree in Biotechnology from Bath University UK.
- Gathered over 30 years of experience in pharmaceuticals manufacturing, storage and distribution according to FDA, EU, WHO, HC, MHRA cGMP/GSDP regulations and guidelines.
- She has gained a track record for dynamic involvement in launching systems in GMP compliance and pharmaceuticals development, manufacturing, storage and distribution. She Secured significant approvals related to pharmaceutical industry benchmarks.
Mr. Paul R Palmer
- Holds an MSc degree in Quality Management and an MBA degree in business administration.
- He has over 35 years experience in the Pharmaceutical Industry.
- He has been an auditor since 1998 and Qualified Person since 2004 and independent Pharmaceutical consultant since 2011.
- Paul is a tutor at RSSL (Reading UK) and University College London providing specialist training in manufacture supply of Pharmaceutical products to trainee & experienced QP’s & RP’s.
Dr. ALUN HOWELLS
PhD
- Holds a PhD degree in synthetic organic chemistry, specializing in peptide chemistry.
- Currently he is a QA Manager and Responsible Person for BBUK Ltd.
- He has worked as a professional chemist in the pharmaceutical industry for more than 20 years.
Mr. Tobias Kuners of Koenders
- Holds a BSc in Chemical Technology from HvA Amsterdam (the Netherlands), a MSc (Corp.) in Manufacturing Management from Cranfield University (UK) and is Certified Supply Chain Professional from APICS (USA).
- Operations Support Specialist and Business Leader with more than 30 years of experience across multiple facets of operations including Project Management, Facilities Services, Maintenance, Engineering, Validation, Packaging and Supply Chain in Cell and Gene, Biotech, (Radio-)Pharmaceutical, Medical Devices, and Food for Special Medical Purposes.
- Coach and mentor, to employees, to team leaders, but mostly to (senior) management. Provides training in systems, processes, techniques, compliance, and qualification. Creates focus and drive assessments and decision-making in short-term and long-term planning and in smaller and larger projects within the organizations.
Mr. Alex Rollins
- Holds a BSc in Business Management with HR major from Edinburgh Napier University in Scotland (with distinction), and an MBA from Northampton university in UK (with Merits).
- Worked for over 5 years as HR specialist in projects managing pharmaceutical compliance and manufacturing .
Mr. David Da Cunha
Engineer
- Studied Chemical Engineering and Biochemistry in France.
- Has 23 years experience in the Pharmaceutical Industry in a multicultural environment, dealing with organizations across the world either with Pharmaceutical Companies, or their contract manufacturers.
- Held several positions in Manufacturing and Quality, mainly in management of organizations. David has a broad knowledge in the field of GxP from API manufacturing to Finished goods, Medical devices and outsourced activities.
- David worked for major Pharmaceutical companies: Eli Lilly, Novartis, Roche, Bayer and is also busy with consultancy activities and lecturing at University.
- Owner of his company “D2C Life Science”, in order to support Pharmaceutical companies in the way they manage Quality and Compliance activities from a Cost, Risk, and Performance perspective.
Dr. Nida Bawaresh
Pharmacist
- Holds a BSc. degree in pharmacy, and worked as head of JFDA Pharmacovigilance and Rationale Drug Use.
- Currently she is working as pharmacovigilance consultant in different fields in pharmacovigilance such as preparation and evaluation of periodic safety updates report (PSUR) and risk management plan (RMP), preparation of pharmacovigilance system master file for industry and pharmacovigilance training.
- Work as lead auditor for pharmacovigilance inspection.
- She has held several workshops and lectures on pharmacovigilance to pharmaceutical manufacturing, drug agents, healthcare providers.
Dr. Hiba Zarour
PhD
- She holds a BSc. degree in Pharmacy, and LLM degree in Intellectual Property and a Juris Doctor degree from Pierce Law.
- She is a VP Intellectual Property at Hikma Pharmaceuticals Global Division.
- She is a member of the trade committee of the International Generic and Biosimilar Pharmaceutical Association (IGBA) and the IP committee at the Jordanian Association of Pharmaceutical Manufacturers and the Saudi National Committee of Pharmaceutical Industries.
- She was a speaker on intellectual property for various national and international organizations like WIPO and CPhI Russia.
Jordanian 2,250 JOD
International 3,175 USD
Can be paid as monthly installments of 250 JOD ($353 USD) for each module.