Please join us on September 26, 2024 to enjoy an evening with Industry experts and ISPE members at High Park Brewery.
This presentation will provide an overview of Digital Validation, including the following;
- The benefits of paperless validation
- Key steps / project phases to implement a paperless validation software tool
- Expanding to other sites, disciplines, and features (i.e. E-Logbooks, eQMS)
- The uses of AI in CQV
Due Date to Register: September 19, 2024
CREDIT: Eligible for 1 CE Hour of Technical Learning
PRESENTATION FULL ABSTRACT
The days of cumbersome paperwork and manual processes are soon to be a thing of the past. Instead, we can expect to see a fully digital validation process that relies on cutting-edge technologies such as digital design documents, digital TOPs, and digital CQV software. Therefore, allowing for increased efficiency, accuracy, and speed. Not only will it reduce the risk of errors and delays, but it will also save time and money. This presentation shall focus on digital validation as it stands currently, and where the industry is projected to go in the future. The presentation shall include review of the benefits of paperless validation, the typical stages of a digital roll-out site wide and enterprise wide, future expansion plans, as well as uses of AI in CQV. The presenters have experience implementing digital validation solutions in North America and Globally, for organizations of various sizes.
PRESENTATION AGENDA
- 1.Introduction & overview of digital validation
- 2.The benefits of paperless validation
- 3.Key steps / project phases to implement a paperless validation software
- 4.Expanding to other sites, disciplines, and features (i.e. E-Logbooks, eQMS)
- 5.The uses of AI in CQV
Event Agenda
| TIME | EVENT |
|---|---|
| 17:00 – 17:30 | Registration |
| 17:30 – 18:00 | Networking Activity |
| 18:00 – 18:30 | Informal Food Service |
| 18:30 – 19:30 | Presentation: The use of Digital Tools and AI in Validation |
| 18:30 – 20:30 | Continued Networking |
Each registrant will have +2 drinks coupons included in the registration price
Speakers
Michael Rodionov
Principal at MMR Consulting
Michael is the principal of MMR consulting, a boutique engineering and integrated digital CQV firm, specializing in process, automation, digital and risk based CQV. Michael has extensive experience in Engineering & CQV project delivery in North America, and internationally / Asia. He has worked with various paperless validation software platforms and has overseen paperless validation implementation projects at the corporate level, site level and project level. Michael brings his expertise to provide end users with practical solutions. He has directly supported multiple major greenfield & brownfield projects, by developing risk-based C&Q and digital validation strategies, reducing cost & schedule significantly.
Viraj Kareka
Digital Validation SME & Associate Director C&Q at MMR Consulting
Viraj has over 17 years of combined pharma / biotech experience in CQV, compliance, and manufacturing. He is a Kneat power user Level 2, a Kneat-certified master trainer, and is trained in ValGenesis. He is a practical industry SME and leader, with experience as both an end user and a consultant. His core specialties include lean “outside the box” risk-based digital C&Q approaches, with planning and implementation of large / complex C&Q projects. Viraj has led major greenfield & brownfield CQV projects which have won ISPE awards, using risk-based approaches. He has also implemented Paperless Validation successfully at multiple companies and has used Paperless Validation across multiple projects.
Event Location
High Park Brewery
High Park Brewery, 839 Runnymede Rd, Toronto, ON M6N 3V8
Attendee Registration
Registration Categories
| Category | Fee |
|---|---|
| Emerging Leaders Members | $20 + tax |
| ISPE Member | $30 + tax |
| Non-Member | $40 + tax |
Meal options
Informal, mixed platters of food served prior to presentation.
Autumn Networking and Educational Event 2024 Sponsors
Autumn Networking and Educational Event 2024 Sponsors
ISPE Canada Autumn Networking and Educational Event 2024
ATTENDEE REGISTRATION – ISPE Autumn Networking and Educational Event 2024