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Draft Annex 11 Computerised Systems
Intensive 1 Day Workshop
Attendance will be Limited to Ensure Maximum Interaction between Delegates
[Download
Workshop Information (193Kb)]
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DATE |
LOCATION |
COST |
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9th October 2008 |
Hotel Mitland, Utrecht, Netherlands |
€790 |
Introduction:
In December 2006, the EMEA concept paper for the
revision of Annex 11 concluded that: “the current EC GMP Annex 11 has its
origins in national guidelines dating from the 1980’s, and over the subsequent
years, computerized systems and applications have evolved to such an extent that
whilst the main principles of the guidance are still valid, the scope and
content are no longer adequate to meet the needs of either the pharmaceutical
industry, or inspectors. As a result of changes in the working environment,
inspectors in the area of computerized systems find it increasingly difficult to
relate serious weaknesses in company procedures and processes for the management
and use of computerised systems to the current GMP
guidance”.
As a result of this problem statement, it was proposed to make significant
changes to Annex 11. In April 2008, the draft Annex 11: Computerised
Systems was released for public consultation, with a deadline for comments from
interested parties set at 31st October 2008.
Workshop Description:
This workshop
will specifically consider details of the proposed changes to Annex 11, and will
include the following topics:
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Does the proposed guideline harmonise
expectations in respect to other current industry guidelines, e.g. GAMP 5 and
ASTM E2500?
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Does the guideline make full use of the
suppliers build, testing and qualification tests to minimize the validation
burden?
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Proposals for the use of automated testing
tools, evidence of challenge tests, load testing, database recovery mechanisms,
system inventories, audit trailing of data access changes.
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How will the concept of ‘independent checks on
critical process parameters’ impact the design and operation of our computerized
systems?
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Have the back up/migration/archiving/retrieval
expectations increased the overall compliance burden?
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Audit trail requirements.
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What are the expectations for the Information
Security Management System (IMS)?
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Does the guideline address the use of web based
technologies and the impact of the implementation and use of global systems?
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Do the proposed changes provide adequate
flexibility?
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Implications for manufacturers and regulators.
Delegates
will have the opportunity to examine in detail various aspects of the draft
annex and be encouraged to use their own experiences in order to openly discuss
the implications of this consensus document.
Who
Should
Attend?
This workshop will be of significant benefit to:
Workshop Leaders:
The workshop
will be coordinated by leading industry experts with significant experience in
performing regulatory inspections, auditing, managing and performing
computerised system validation projects and in the management and use of
computerised systems within all GxP areas.
Ian K. Sykes, PhD
Director, Pharmaceutical Consultancy Services (PCS)
Ian qualified in Microbiology, Immunology and Virology. After working in the
pharmaceutical industry Ian joined the U.K. Medicines Inspectorate, with
responsibility for biological and biotechnology products. He established PCS in
1990 and with a global customer base, PCS offers services in consultancy,
auditing and training for the pharmaceutical, chemical and related healthcare
industries. Ian is a registered Qualified Person.
Colin Goddard
Director, PAC B.V.
Colin has been working in the field of automation since 1982. Having
worked as a Programmer, Analyst, Programming Manager, IT Manager and European IT
Director in a number of European countries, he has developed a high level of
knowledge regarding the use and control of computerised systems in many
'high-tech' areas. Colin has worked in the pharmaceutical, medical device
and biotechnology industries since 1989 and has extensive experience of
computerised systems in manufacturing, distribution and clinical research.
Since co-funding PAC B.V. in 1993, Colin has consulted extensively in the fields
of computerised systems validation, software supplier audits, inspection of
computerised systems and regulatory inspection preparation.
Other speakers will be announced shortly.
Workshop Language:
The workshop will be delivered in both Dutch and English.
The
Venue:
Hotel Mitland, Utrecht, Netherlands
Tel: +0031 (0) 30 271 5824, Fax: +0031 (0) 30 8271
9003,
Web: www.mitland.nl
Situated on the outskirts of Utrecht approximately a 5 minute drive from the
city centre, Hotel Mitland has 135 luxuriously furnished rooms and is situated
in a splendid park offering wonderful views of the old 'De Bilt Fortress'.
Enjoy an extensive lunch or dinner at the beautiful restaurant
situated on the waters of ‘Fort de Bilt’ or relax by participating in one of the
extensive activities offered by the hotel including; bowling, swimming, cycling,
jogging or walking.
Workshop Fees and Reservations:
The fee for the course is €790. Delegates should book their own dinner, bed and
breakfast, as accommodation is not included in the course fee. The hotel will offer a conference discount rate if you mention that
you are a delegate.
Reservations not confirmed by payment within reasonable time will be allocated
to any persons on a waiting list. Payments should be made by cheque to
Pharmaceutical Consultancy Services BV.
Cancellations:
Written cancellations will be accepted up
to 31 days before the date of the
course, after which a cancellation fee will be payable. Unfortunately no refund
can be made for cancellations within 10 working days of the course start date
and the full course fee will be due for delegates who fail to attend.
Substitutions may be made at any time up to the start of the course, free of
charge.
We reserve the right to change the programme,
speakers, date or venue without notice, or to cancel an event. If cancellation
occurs delegates will be notified as soon as possible and will receive a full
refund of fees paid. Pharmaceutical Consultancy Services BV or Honeyman Group Limited will not be responsible for
transportation, accommodation or other costs incurred due to cancellation.
[Download
Booking Form 109Kb]
To avoid disappointment an e-mail/telephone/fax
reservation is advisable prior to sending your booking form and payment.
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