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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Shared Facilities – Update on EU draft guidance and revisions to Chapters 3 and 5 of the GMPs |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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