GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (2nd Edition, July 2022)
GAMP 5 2nd Edition represents an incremental revision to facilitate the adoption of more recent innovations and technical advances including Agile methodologies, cloud-computing, automated tools, blockchain, AI/ML, and Open Source Software. The guide supports the use of critical thinking to strengthen the risk-based approach to computerized system lifecycles and it facilitates the effective and efficient use of valuable resources by the application of appropriate and proportionate practices, encouraging innovative approaches to managing risk to patient safety, product quality, and data integrity while supporting benefit to public health.
Hear from our esteemed speakers as they explain the guide’s evolving approaches and the importance of applying critical thinking in specific circumstances. In-person attendance is encouraged, but there will also be a virtual option to attend this program.
Agenda:
5:00 - 6:00 PM - Networking (Cash Bar)
6:00 - 6:30 PM - Buffet Dinner
6:30 - 8:00 PM - Presentation
Registration will open at 5:00pm and a cocktail hour will be held until 6:00pm; a buffet dinner will be served at 6:00pm, followed by the presentations. One complimentary drink ticket will be provided, followed by a cash bar. The program will conclude at 8:00pm.
Speakers:
Lorrie V. Schuessler
Retired, Chairperson
GAMP Americas
Stephen Ferrell
VP IT Governance & Software Assurance
CompliancePath Limited - an Ideagen Company
Paige Kane, PhD, CPIP
Director of Knowledge Management
Merck
Levi Schenk, MS, CSM, CSSBB
Head of I&T Framework and Governance
CSL Behring
Registration Information:
|
COST |
|
|---|---|
|
ISPE Members |
$70 |
|
Non-Members |
$90 |
|
Emerging Leader/Student |
$45 |
| VIRTUAL - ISPE Members | $25 |
| VIRTUAL - Non-Members | $35 |
| VIRTUAL - Emerging Leader/Student | $15 |