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This seminar is intended for industry professionals who are
responsible for Engineering or Engineering firms that are involved in planning
building or renovating pharmaceutical facilities, Quality Assurance, Regulatory and
validation personnel. In addition, contractors, equipment and facility suppliers and
others who participate in this process, such as process development and operations
personnel at all levels of management will benefit from learning what to expect and
how to foresee and prevent problems.
Course Program
| Duration
|
Topic |
Speaker |
| 08.30 -
09.00 |
Registration and Breakfast
|
| 09.00 -
09.15 |
Opening Remarks
Introduction |
Rachel Karpel
President
Elect |
| 09.15 - 10.00
|
GMP Requirements in Primary Packaging, Weighing
and Sampling areas and Warehouse |
Yafit Toledano
Ministry of Health, Institute of Standardization and Control of
Pharmaceuticals
|
| שימו לב להרצאה מיוחדת
של משרד הבריאות בנושא דרישות לחדרי שקילה, דיגום, לחות, לחץ וסינון אוויר וכל
הנוגע למוצרים לא סטריליים |
| 10.00 -
10.45 |
Maintenance philosophy and
concepts |
David Biran
Facilities
Mechanical Engineering Manager, Intel |
| 10.45 -
11.00 |
Coffee Break |
| 11.00 -
11.45 |
GMP compliant Water Systems – Germ free;
No media; No Chemicals |
Shlomo Sackstein
COO
Biopharmax |
| 11.45 -
12.30 |
Shared Facilities – Update on EU draft
guidance and revisions to Chapters 3 and 5 of the GMPs |
Karen Ginsbury
CEO, PCI
Pharma |
| 12.30 -
13.30 |
Lunch |
| 14.15 -
15.00 |
GMP compliant design and maintenance of critical
utilities: nitrogen, compressed air, vacuum |
Uri Boneh
Director, Global
Engineering, Teva |
| 15:00 -
15.30 |
Lifecycle approach to VMP |
Moti Izhar
QA &
validation Department Ludan Engineering Israel |
| 15.30 -
15.45 |
Coffee Break |
| 15.45 -
16.30 |
Maintaining a GMP compliant HVAC system for
aseptic processing |
Daniela Berkowitz
Plant
Engineering Manager, Kamada |
| 16:30
– 17:00 |
Panel discussion and Q&A
|
Facilitators: Karen Ginsbury, Moti
Izhar |
Note: the program and speakers are tentative and subject to
change without prior notice.
Target Audience
This course is suitable for any person involved in cleaning validation which
covers a broad variety of disciplines:
R&D personnel developing processes
including cleaning processes, engineering designing “cleanable”
equipment and facilities, CIP / COP systems; operations personnel involved in
performing or supervising cleaning performance; QA, QC personnel, validation
personnel, personnel developing analytical methods for the cleaning validation,
purchasing personnel who select / change cleaning agents and tools and HR personnel
involved in selecting cleaners or outsourcing this critical operation.
Participation Fees:
PDA members - 850 NIS
Non members - 1050 NIS
Become a member at the international PDA
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