- \n
- Flawless FDA Inspection Handling and Response (Drugs & Biologics Track)<\/b>\u00a0\u2014 Discover how to manage FDA investigators on-site, how to defend yourself where appropriate and craft 483 responses that fend off warning letters<\/li>\n
- Process Validation for Medical Devices: Preparing for a QSR Inspection (Medical Devices Track)<\/b>\u00a0\u2014 Understand the fundamental requirements of medical device process validation, analyze warning letters so you can apply lessons learned and gain clarity on what you need to do, when to do it and what records to keep<\/li>\n
- ICH E6(R2): How to Be Inspection Ready with Your Sponsor Risk Management Program (Clinical Trials Track)<\/b>\u00a0\u2014 Gain insight into what you must do to comply with the challenges inherent in the recent ICH E6(R2) guidelines with this hands-on, interactive training<\/li>\n<\/ul>\n
On Oct. 24, day one<\/b>, you\u2019ll hear how to create a world-class quality culture, attend a panel discussion on the 10 best and 10 worst things to do when FDA staff are on site and gain focus through an extraordinarily helpful interactive exercise \u2014 a mock inspection. During the day\u2019s three breakout tracks, you can choose:<\/p>\n
- \n
- Drugs & Biologics Track<\/b>\n
- \n
- Concept of Operations: How Integration of the FDA Facility Evaluation and Inspection Program Impacts Your Organizations<\/li>\n
- Today\u2019s Track & Trace: What Merck and the FDA Have Learned<\/li>\n
- Panel Discussion: The US\/EU Mutual Recognition Agreement (MRA) for Drug GMP Inspections<\/li>\n<\/ul>\n<\/li>\n
- Medical Devices Track<\/b>\n
- \n
- FDA\u2019s Shift from QSR to ISO 13485:2016: A Significant Change for Inspections<\/li>\n
- Preparing for a MDSAP Audit: A Case Study from the Manufacturer\u2019s Perspective<\/li>\n
- Panel Discussion: EU-MDR: Final Push for Compliance by the May 26, 2020 Deadline<\/li>\n<\/ul>\n<\/li>\n
- Clinical Trials Track<\/b>\n
- \n
- Meeting CRO-Vendor Oversight Requirements<\/li>\n
- Validating Your Systems and Equipment for Compliance<\/li>\n
- Quality by Design \u2014 Build Quality into Clinical Trials to Proactively Identify and Mitigate Risks<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
On Oct. 25, day two<\/b>, you\u2019ll get inspection-ready through covering:<\/p>\n
- \n
- The latest patterns in FDA\u2019s 483s and warning letters, so you can pass your next inspections easily<\/li>\n
- Good techniques for data organization and how to create effective new SOPs for electronic document management<\/li>\n
- New developments in FDA\u2019s field operations reorganization and program alignment; how this will impact your inspections?<\/li>\n<\/ul>\n
The summit\u2019s agenda, presentations and panel discussions are simply unmatched. Ensure successful inspections each time. This best-in-class summit is key.<\/p>\n
- Process Validation for Medical Devices: Preparing for a QSR Inspection (Medical Devices Track)<\/b>\u00a0\u2014 Understand the fundamental requirements of medical device process validation, analyze warning letters so you can apply lessons learned and gain clarity on what you need to do, when to do it and what records to keep<\/li>\n
![\"\"](\"https:\/\/dhrresearch.org\/wp-content\/uploads\/2019\/08\/register.jpg\")
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