| Time | Description |
| 9:00 - 10:00 | Event Registration |
| 10:00 - 10:40 |
A Look Forward on the Business/Regulatory Trends for the Pharma/Biopharma Industry and How PDA is Responding abstract R. Johnson (President, PDA) |
| 10:40 - 11:20 | Update on PDA Technical report on Process Validation abstract H. Baseman (COO, Valsource and Chair Elect, Board of Directors PDA) |
| 11:20 - 12:00 | Quality Systems for Contract Manufacturing Organizations abstract S. Schniepp (VP, Quality Oso Bio, and Member Board of Directors, PDA) |
| noon - 1:00 | Networking Lunch with the Experts Speakers will be identified for each table. Feel free to network with the speaker or topic of your choice. |
| 1:00 - 1:40 | Internal Auditing of Quality Systems abstract J. Thomas (Quality and Regulatory Consultant) |
| 1:40 - 2:20 | Inspection of Quality systems; an FDA Investigator's Perspective Mihaly S. Ligmond (Investigator, National Expert Pharmaceutical, Food & Drug Administration) |
| 2:20 - 3:00 | Q/A |