| Training Elements as applicable |
|
Training |
|
internal |
external |
|
Date, Name of Training and Training
Provider |
|
Applicable international GMP guidance and legislation: |
|
|
|
|
Applicable national GMP guidance and legislation: |
|
|
|
|
Marketing and manufacturing authorisation systems and their relationship/ regulatory affaires: |
|
|
|
|
Risk analysis and risk management: |
|
|
|
|
Good documentation practice and batch record review: |
|
|
|
|
Complaint handling and recalls: |
|
|
|
|
Change Management/ Change Control: |
|
|
|
|
Product Quality Review: |
|
|
|
|
Supplier Qualification: |
|
|
|
|
Auditing techniques : |
|
|
|
|
Inspection preparation: |
|
|
|
|
Pharmaceutical Contracts: |
|
|
|
|
Microbiology: |
|
|
|
|
Process engineering/ HVAC Systems: |
|
|
|
|
Utilities: |
|
|
|
|
Analytical equipment and instrumentation: |
|
|
|
|
Analytical methods and validation: |
|
|
|
|
Stability testing: |
|
|
|
|
OOS/ Deviation handling and failure investigation: |
|
|
|
|
Statistics: |
|
|
|
|
Computer systems and validation: |
|
|
|
|
Pharmaceutical technologies and processing (Oral solids, Sterile, Liquids, Semi-solids, Herbals): |
|
|
|
|
Manufacturing, quality control, release and distribution of IMPs: |
|
|
|
|
API: quality, technology, equipment, processes: |
|
|
|
|
Instrument and equipment qualification, calibration, maintenance: |
|
|
|
|
Storage and distribution: |
|
|
|
|
Pharmacovigilance: |
|
|
|
|
Communication skills, time and conflict management: |
|
|
|
