Date: 22 January 2014
Location: Kfar Hamakabbiah, Ramat Gan
Hours: 9:00-17:00
Registration: 8:30-9:00
SKU: P14724
שימו לב להרצאה מיוחדת של משרד הבריאות בנושא דרישות לחדרי שקילה, דיגום, לחות, לחץ וסינון אוויר וכל הנוגע למוצרים לא סטריליים


Pre-book a place to avoid disappointment as this is likely to be a very popular course

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
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11.45 - 12.30 Shared Facilities – Update on EU draft guidance and revisions to Chapters 3 and 5 of the GMPs Karen Ginsbury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


Organized & Produced by
Bioforum - Applied Knowledge Center
Golda Meir 5, Weizmann Science Park
P.O.B. 4034 Ness Ziona, Israel, 70400
Tel: 08-9313070
Fax: 08-9313071