GMP Professional lectures schedule Part I
Day 1
Regulatory Agency Governance
1-Global regulatory framework(21CER-EU-PICS-Canadian)
2- Regulations and guidance’s (9CFR – ICH)
Day 2
I. WHO GMP STRUCTURE
II- WHO good manufacturing practices for pharmaceutical products: main principles
1. Pharmaceutical quality system
– Quality risk management
– Product quality review
2. Good manufacturing practices for pharmaceutical products
3. Sanitation and hygiene
4. Qualification and validation
5. Complaints
6. Product recalls
7. Contract production, analysis and other activities
– General
– The contract giver
– The contract acceptor
– The contract
Day 3
8. Self-inspection, quality audits and suppliers’ audits and approval
I- First-, Second- & Third-Party Audits, what are the differences
II- IPEC Federation
III -Training and personnel qualification
Day 4
1-Regulatory inspections
2- Regulatory agency reporting
– Post-marketing changes
– Regulatory reporting requirements
Day 5
1) Site master file (SMF)
2) drug master file (DMF
Day 6
A . Quality management system (QMS)
1. QMS elements
2. QMS requirements
B. Quality unit (site) management
Day 7
A- Product quality complaints vs. adverse event reports
1. Quality complaints
2. Adverse events and pharmacovigilance
3. Problem response
B- Change control and management
1. Pre-change analysis
2. Post-change analysis
Day 8
Training and personnel qualification
1. Needs analysis
2. Staff development requirements
** Documents and records management
1. GMP document system
2. GMP compliance records
3. Record retention
Day 9
– Investigations and corrective and preventive action (CAPA)
1. Trigger events
2. Response actions
3. CAPA feedback and trending
– Audits and self-inspections
1. Audits processes and results
2. Audit follow-up
3. Ineffective corrective actions
Day 10
A – Product trend requirements (APR and PQR)
B- Supplier and contractor quality management
1. Supplier quality systems
2. Supplier controls
3. Supplier evaluation
Day 11
A. Compendia (US, Europe, and Japan)
1. Required vs. informational compendia
2. Marketing requirements vs. compendia
3. Compendia methods review
4. Compendia requirements review
5. Biological, microbiological, chemical, and physical test methods
Day 12
B. Lab investigation of aberrant results
1. Test data
2. Aberrant results Identify, analyze, and interpret data on processes or products that are out-of-
C. Instrument control and record-keeping
1. Instrument control
2. Instrument calibration
Day 13
** EXAM Revision
Day 14
** FINAL EXAM