Course Objectives
This course is designed for personnel of Basic and intermediate GMP levels. It will provide cGMP knowledge, understanding, and the responsibilities for implementing the cGMP guidelines in the job duties. This course is helpful for annual GMP refreshment training and encouraging personnel to be alert in controlling and maintaining the GMP compliance level.
Detailed Intended Learning Objectives (ILOs):
This course is designed to make the participants acquire a clear-cut understanding of:
- Will be able to understand and apply GMP principles from concepts to reporting in a managerial levels.
- For the beginner, the course provides guidance on how cGMPs apply to their role and responsibilities and how to apply these principles in their daily activities.
- For the intermediate level, they will be able to apply what they have learned to better manage quality, solve problems, and make improvements.
- This course is helpful for personnel as an annual GMP refreshment training.
- This course (including the case studies) is encouraging personnel to be alert in controlling and maintaining the GMP compliance level.
- This course provides the tools and methods of maintaining the GMP environment and implemented quality management system.
Course Content
Regulatory requirements:
- Introductions (WHO, FDA, EU, and ICH)
- Food, Drug, and Cosmetic Act (FDCA).
- Eudralex guidelines.
- The medical product lifecycle from discovery to approval.
- How the regulations define quality
- Quality vs. Compliance.
The GMP requirements:
- Eudralex Volume 4 GMP Overview.
- Pharmaceutical quality system.
- Organization and responsibilities toward quality activities.
- Personnel:
- Key personnel responsibilities toward the quality system.
- General and specific training
- Premises and equipment design for GMP compliance
- Facility design and specifications
- Equipment URSs and its impact on GMP compliance.
- Qualification and validation: focusing on the points to be considered.
- Utilities monitoring and control.
- Sanitation& hygiene
- Documentation system: protocols, procedures, records, and reports
-Types of documents
- Site Master File SMF
- Document control and archiving
- Technical writing
- GMP in pharmaceutical quality control laboratories
- Sampling of starting and packaging materials.
- Reference and retention samples.
- Test method validation.
- Handling of specification test results OOS and out of trend OOT.
- Parametric release/real-time
- Control and monitoring outsourced activities.
- Complaints handling.
- Recall system.
- Internal Auditing/ Self Inspection.
Consultant
Dr. Fawzy Hassan
> A pharmaceutical/biopharmaceutical consultant with high Experience, who provided consultations for industrial facilities in Egypt, Africa, Turkey, Uzbekistan, Gulf area. He provided training programs for many years in cooperation with Egyptian, Canadian, Arabic, and Asian organizations. > Academic & Professional Qualifications: - BSc, Chemistry, Cairo University 1985. - MSc, Biochemistry, Cairo university. - Diploma, Quality Assurance & Quality Control, TIPT, Canada. - Certified Quality Manager, AUC, Cairo.
Price Options
70% Special Discount
Clients From outside Egypt:
100 USD
(Instead of 335 USD)
Clients From Inside Egypt:
1100 L.E
(Instead of 2670 L.E.)