To: Michal Gavish

PCI
Pharmaceutical Consulting Israel, Ltd
Hibner 4/2, Petah Tikva, 49400
Tel: +972+(0)3-9213878
Fax: +972+(0)3-9214097
Reg. No. 51-250658-5
Aseptic / Terminally Sterilized Production
State of the Art Risk Management
Course Dates
Monday or Tuesday 13, 14 April 2015
Give yourself a one day refresher training to come up to speed on recent developments in aseptic
processing. Annex 1 of the EU GMPs is currently under revision. Aseptic processing is one of the
riskier tasks routinely undertaken in the pharmaceutical industry. There are a large range of tools
applied both for control and monitoring of these operations. Terminal sterilization is generally
considered safer and even a candidate for parametric release. All of these points will be addressed
in an interactive workshop using a risk based approach to analyzing, controlling and monitoring
risks associated with these critical activities. Topics to be covered:
 Review of regulations:
 EU Annex 1
 FDA Aseptic Processing Guide (is it still relevant)
 Relevant PIC/s Guides
 USP <1116> on Cleanrooms and Contamination Recovery Rates
 Relevant PDA Technical Reports
 Relevant ISO guides
 Isolators, RABs and conventional cleanrooms
 Containment vs Clean – what is the difference
 The usual culprits:
 Facility design
 Gowning
 Cleaning and disinfection
 Environmental controls and monitoring
 Media fills
All viewed through the prism of:
 Risk identification
 Controls
 Risk acceptance and communication
 Risk monitoring and communication
 Metrics
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PCI
Pharmaceutical Consulting Israel, Ltd
Hibner 4/2, Petah Tikva, 49400
Tel: +972+(0)3-9213878
Fax: +972+(0)3-9214097
Reg. No. 51-250658-5
The workshop is relevant for start-ups, established multi-nationals pharmaceutical companies,
biotechnology companies, manufacturers of investigational and commercial sterile products or
APIs being used in sterile medicinal drug products. Qualified Persons, Quality Personnel, Research
and Development personnel, Regulatory Affairs persons as well as product formulators,
operations, production, supply chain and purchasing personnel. Persons involved in hospital
pharmacy compounding, operating pilot plants or manufacture of clinical trials / small scale
batches in production will find this workshop of value. The workshop is also relevant for contract
manufacturers providing sterile and aseptic services to the pharmaceutical industry.
Course Instructor
This course will be presented Karen Ginsbury, CEO of PCI Pharmaceutical
Consulting Israel Ltd. Karen has 27 years’ experience in the
pharmaceutical industry and has worked closely with:
- API and finished pharmaceutical manufacturers to set-up, maintain and
improve their GMP compliant quality systems for aseptic processing and terminally
sterilized products
- Virtual companies and multi-nationals to develop flexible but compliant quality
systems for the manufacture and control of sterile IMPs
- outsourced operations setting up and implementing quality systems which meet the
needs of the Contract Giver and Contract Acceptor
Karen has an MSc degree from Birkbeck College, University of London, UK, in
microbiology making her particularly well placed to explain the vagaries of
microbiological control.
As a member of PDA’s Regulatory Affairs and Quality Advisory Board, Karen Ginsbury is
actively involved in commenting groups on EU, US and worldwide changes to GMPs and
guidances as well as interpretation. This course is an opportunity to learn from her
unique perspective as to what is happening both in Europe and the USA as globalization
affects industry’s ability to stay updated with aseptic processing regulation and risk
management.
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