Audit and Self Inspection
September 2008
Intensive 3-day course

Includes Optional Close Out Examination for Professional Qualification Certificate

[Download Course Brochure (303Kb)]

Introduction
Article 14 of European Directive 91/356/EEC clearly places the responsibility upon all pharmaceutical manufacturers to operate a system of self-inspections in order to continually monitor compliance with Good Manufacturing Practices (GMP). Such programmes should also result in appropriate corrective measures being taken to ensure ongoing improvements to the quality system. Therefore, it is necessary for self inspections to be adequately planned, performed, and comprehensive in nature.

The principles of self-inspection are being increasingly applied to suppliers and service providers to the pharmaceutical industry and whilst many can be applied in such external audit situations, there can be significant differences in practice when inspecting, for example, API manufacturers, packaging material suppliers, contract manufacturers or analytical services.

This course has been delivered successfully throughout Europe and has been designed by professionals who have extensive experience of the development and execution of audit and self-inspection programmes in the pharmaceutical industry.

Course Tutor
Ian K. Sykes PhD
Director, Pharmaceutical Consultancy Services (PCS), The Netherlands

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.

Course Language
The course will be delivered in English.

Who Should Attend?
The course is intended for personnel at all management levels who may be involved with the organisation and performance of self-inspections and/or external audits, in particular; Quality Assurance, Production and Quality Control personnel.

Staff who may be directly or peripherally involved with regulatory and/or customer audits will also benefit from the course content.

Course Programme
Day 1 Start @ 08:45, Finish Day 3 @ 16:15

Inspection Types, Methods and Techniques
Comprehensive review of various inspection situations e.g. internal and external suppliers and the different inspectional approaches that can be applied, e.g. trace forward, trace back and complaints.
Application of the “3 A Principle” to inspections.

Planning, Preparation and Performance of Inspections
Developing a systematic planning and preparation strategy for each inspectional situation and consideration of the information required to plan a successful inspection.
Critical success factors in the performance of inspections and audits, together with case studies, examples and practical tips.

Communication Skills
Developing a good relationship using the EDICT model and building credibility. The use of power and influencing skills to direct the inspection. Maximising information flow through the application of good questioning skills. Learning to deal effectively with difficult behaviour.

Inspection Checklists
The advantages and disadvantages of inspectional checklists. The aide memoire versus the detailed questionnaire. Using criteria checklists and departmental inspectional checklists as inspectional tools. All delegates will be provided with an example of criteria and departmental inspectional checklists which will serve as useful aides memoirs back in the workplace.

Evaluation of Inspection Findings
The use of inspection findings (symptoms) to diagnose underlying quality deficiencies (diseases), classification and categorisation of inspection findings to focus corrective action. Performing root cause analyses on inspection findings.

Inspection Reports
Developing a consistent approach to inspection reports. Separating observations (facts) from opinions. How much detail should a typical inspection report contain? The use of draft reports to gain commitment.

Rapid Auditing
How can a GMP inspection be efficiently organised in the space of a single day?

Supplier Audits
Special considerations when planning and performing audits on suppliers of Active Pharmaceutical Ingredients (APIs). Practicalities of enforcing follow-up action or gaining commitment to change.
The use of audits on suppliers to reduce testing of incoming raw materials.

The Ideal Audit Simulation
The Table Top Audit: Featuring a slide show of an actual pharmaceutical facility, delegates can perform a virtual trace-forward audit from warehouse and goods receipt through sampling, manufacturing, IPC/laboratory testing and distribution.

Upon Course Completion, Delegates Will:
- Be able to develop an appropriate inspection plan for each audit situation.
- Know what information is required to effectively plan an audit.
- Understand the importance of good communication skills.
- Be able to perform investigative audits.
- Be able to effectively analyse inspection findings and determine root cause analyses of quality problems.
- Be able to prepare effective audit reports.
- Understand the importance of follow-up procedures in gaining commitment and improvement.
- Understand the possibilities and limitations of the inspection process.

Delegate Certification
Delegates will be given the opportunity to participate in a close-out examination based on the contents of this course. Successful candidates will be provided with a GMP inspection qualification certificate. In addition, all delegates will be provided with an attendance certificate, irrespective of their participation in the optional examination.

The Venue
Novotel York, Fishergate, York, YO10 4FD
Tel: +44 (0) 1904 611660,      Fax: +44 (0) 1904 610925,     Web: www.novotel.com

The Novotel York is a modern hotel situated on the banks of the River Foss and within walking distance of all the major attractions in one of England's favourite tourist destinations. London's Kings Cross is approx. 2 hours away, there is a rail link to Manchester Airport and Leeds/Bradford Airport is convenient. York is easily accessed from major national roads. Parking and leisure facilities are available.

Course Fees and Reservations
The fee for the course is £1,325.00 sterling (€1,990.00) plus VAT where applicable. This covers all tuition fees, comprehensive course notes, refreshments and lunch. A course certificate of attendance is issued to each delegate who attends the full course. 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 your 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 Honeyman Group Ltd.

Discounts
Book early and receive a 10% discount if payment is received 6 weeks in advance of the course commencement date.
Discounts are also available for multiple bookings, and for government and regulatory agency employees - please contact us for details.

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. Honeyman Group Limited will not be responsible for transportation, accommodation or other costs incurred due to cancellation.

To avoid disappointment an e-mail/telephone/fax reservation is advisable prior to sending your booking form and payment.