21 CFR part 11 is an important part of any Bio / Pharmaceutical system. This regulation has been a requirement both in practice and in fact for many years in many parts of the industry.
This seminar is here to dispel the myths and misconceptions and give participants better understanding of how to implement risk based controls over the ever increasing use of computerized systems in the pharmaceutical industry.
Anyone attending the seminar will be able to address the following questions:
- What are the stipulations of CFR 21 part 11
- What systems need to confirm to CFR 21 part 11
- How do I implement CFR 21 part 11 in utilities, process and IT systems
- How do I validate the implementation of CFR 21 part 11
- What are the differences between the FDA-EMA, 21CFR11-Annex 11
Seminar Program
| Duration |
Topic |
Speaker |
| 09:00 – 09:30 |
Gathering |
| 09:30 – 09:45 |
Introduction and Overview of 21CFR11 in the Industry |
Shlomo Sackstein
Biopuremax |
| 09:45 – 10:30 |
Comparison FDA-EMA, 21CFR11-Annex 11 |
Shlomo Sackstein
Biopuremax |
| 10:30 – 11:00 |
Coffee Break |
| 11:00 – 11:45 |
What is needed for 21CFR11 compliance including E signatures |
Mike Zeevi
Softquest |
| 11:45 – 12:30 |
Case study of 21CFR11 Application in Utilities/Production |
Lior Meir
Biopharmax |
| 12:30 – 13:30 |
Lunch |
| 13:30 – 14:15 |
Applying 21 CFR Part 11 to IT Infrastructure Systems |
Alon Avni
Protalix |
| 14:15 – 15:00 |
"How to" Validation of 21CFR11 with/without Case Study |
Keren Zalkind Zigelboim
RAFA |
| 15:00 – 15:30 |
Questions and Discussion |
Note: the program and speakers are tentative and subject to change without prior notice.
Target Audience
This Seminar is a perfect learning session for:
- Engineering and Project managers wanting to learn relevant methods in the field
- Software and hardware engineers looking into how implementation should be done
- IT managers looking for specific application in their field
- Quality responsible persons wanting to know which systems are up for CFR 21 part 11 implementation
- Validation managers and engineers
- Operations and logistic personnel
Participation Fees:
PDA members - 850 NIS
Non members - 1050 NIS
Become a member at the international PDA
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