ECA - GMP meets Development
Art-No.: A-999
Date: 13 - 15 June 2018
Price: EUR 380,-
The Conference folder includes the following topics:
| No. | Topic | Summary | Pages |
| 12627 | Global GMP Requirements from Phase 1 to Scale-up and Transfer | 0 | 24 |
| 12628 | IMP´s in the context of ICH Q8, Q9 and Q10 | 0 | 34 |
| 12629 | Analytical Development | 0 | 35 |
| 12630 | Packaging and Supply of Clinical Trial Materials | 0 | 33 |
| 12631 | IMP-Manufacturing: how much Qualification and Validation is needed? | 0 | 40 |
| 12632 | Change Control for IMPs | 0 | 15 |
| 12633 | Interactive Session: Important Documents in Pharmaceutical Development | 0 | 37 |
| 12634 | The FDA Pre-Approval Inspection (PAI) | 0 | 50 |
| 12848 | Case Study: How to implement a cleaning validation in pharmaceutical development | 0 | 22 |
| 13143 | Case Study: How to handle Deviations in an R&D Environment | 0 | 30 |
| 13144 | The GMP/GCP Interface | 0 | 36 |
| 13145 | The Role of the QP in Pharmaceutical Development and IMP Release | 0 | 32 |
| 13146 | Workshops | 0 | 11 |
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others