Successful Management of Sterile Products Quality
1–2 December 2008
Barcelona, Spain
Seminar Leaders
Lynn Bryan, Ballygan Consulting,
Rob Walker, Rob Walker GMP Consultancy Ltd,
- Regulators views on risk management – speakers from FDA and MHRA
- Advice and support on EU GMP Annex 1: 2008
- Outline of the updated ISPE Baseline® Guide for Sterile Products and Processes
This seminar will provide the latest information in the sterile manufacturing arena on best practices used to manage quality of product for patient safety.
An update on current European and FDA Good Manufacturing Practice (GMP) Regulations will be given, with discussion on the implementation of Annex 1, and ISO guidelines in the area of healthcare products.
Through a series of seminar sessions, updates, discussions and workshops, this seminar will address risk assessment issues, best practices for new regulation and technology, regulatory updates, project facility issues associated with refurbishment, new technologies and barrier systems. The updated ISPE Baseline® Guide for Sterile Products and Processes will also be discussed, alongside updates from recent events and through expert speakers on this important topic.
Speakers include regulators from FDA and MHRA, plus industry leaders and professionals active in handling sterile products.
Take Back To Your Job
- A regulatory update on sterile products and risk management issues – including views from regulators
- An understanding of risk – how it is defined, managed and assessed
- Gain knowledge on the latest technological developments and practices
- Insight on facility conversion considerations
- Case studies based on experience, best practices and current regulation
- Updates from a range of important resources, including regulators, expert speakers and a round up from other recent events
Agenda
Monday, 1 December
10.00 – 10.15 Welcome and Introduction
Lynn Bryan, Ballygan Consulting (UK)
Rob Walker,GMP Consultancy Ltd (UK)
10.15 – 11.00 Annex 1 Issues and Evolving Practice
Gordon Farquharson, Bovis Lend Lease Pharmaceutical (UK)
- Background on the publication of the February 2008 revision
- Review of the essential changes
- EMEA responses to industry concerns and questions
- Impact of changes to classification of clean zones and airborne particle monitoring
- Implementing the new vial capping and oversealing requirements
11.00 – 11.45 Risk Assessment with Regard to Sterile Products
Rob Walker on behalf of Tim Eaton, AstraZeneca (UK)
Session updates available on-line, visit www.ispe.org/barcelonaconference
11.45 – 12.30 Update on ISPE Sterile Guide
Gordon Farquharson, Bovis Lend Lease Pharmaceutical (UK)
Session updates available on-line, visit www.ispe.org/barcelonaconference
12.30 – 13.45 Lunch and Networking Break
13.45 – 14.30 FDA View on Risk Management
Speaker to be confirmed
14.30 – 15.15 MHRA View on Risk Management
Paul Hargreaves, MHRA (UK)
15.15 – 15.45 Coffee and Networking Break
15.45 – 17.30 Workshop A: Environmental Monitoring
Workshop B: Risk Management
Lynn Bryan, Ballygan Consulting (UK)
Rob Walker, GMP Consultancy Ltd (UK)
17.30 – 17.45 Questions and Answers, Close of Day 1
Lynn Bryan, Ballygan Consulting (UK)
Rob Walker, GMP Consultancy Ltd (UK)
17.30 – 18.30 Networking Reception
Tuesday, 2 December
09.00 – 09.15 Review of Day 1, Introduction to Day 2
Lynn Bryan, Ballygan Consulting (UK)
Rob Walker, GMP Consultancy Ltd (UK)
09.15 – 10.05 Sterile and Safe - Barrier Systems for Product and Operator Protection
Johannes Rauschnabel, Bosch Packaging Technology (Germany)
Mathias Kreher, Bosch Packaging Technology (Germany)
- Definitions and borderlines
- Sterility
- Air management
- Transfers
- Case studies (compounding, filling and lyo-loading)
10.05 – 10.35 Coffee and Networking Break
10.35 – 11.25 The Impact of Disposable Technologies on Sterile Processing
Miriam Monge, Biopharm Services Ltd (UK)
Jörg Zimmerman, Vetter Pharmaceuticals (Germany)
- Where are disposable technologies most used in sterile processing through to final filling?
- What are the advantages/disadvantages?
- Latest technology innovations
- End-user case studies
11.25 – 12.15 Challenges in Facility Conversion: A Case Study for a Sterile Facility
John Seagrief, 5pharma (UK)
- Establishing constraints of the existing building and HVAC systems
- Designing a new facility to incorporate sterile requirements and maximise opportunities
- Cost and energy-saving approaches
- Progress through the facility build to functional sterile suite
12.15 – 13.45 Lunch and Networking Break
13.45 – 14.40 EU GMP Annex 1: 2008 and Non Viable Particle Counting
Tim Russell, Facility Monitoring Systems Ltd (UK)
- Cleanliness classification and process monitoring – what is the difference?
- New 5μm limits and sample frequency
- Considerations when selecting manifolds or point-of-use particle counters
- Understanding the data: How a monitoring system can be used to detect contamination events
14.40 – 15.35 Media Fill Issues
Declan Quinlan, Genzyme (Ireland)
- Meeting regulatory expectations for process simulation testing
- Organise materials and personnel in launching the media fill
- Design of a media fill study for form-fill and lyophilisation operations
- Overcome common challenges and difficulties in developing a process simulation
- Determine the correct sample size and statistical approach for your media fill
- Determine the technical limitations of media fills
- Identification of the potential weaknesses of your aseptic operation which might contribute to the microbiological contamination of the product
15.35 – 16.15 Questions and Answers, Close of Seminar
Lynn Bryan, Ballygan Consulting (UK)
Rob Walker, GMP Consultancy Ltd (UK)