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Pharmaceutical Training Course |  Good Engineering Practice

Good Engineering Practice
May 2008 & November 2008
Intensive 2-day course

[Download Course Brochure (310Kb)]

DATE

LOCATION

COST

14th - 15th May 2008

Tara Towers Hotel, Dublin, Ireland

£1,025.00 (€1,545.00) + VAT

10th - 11th September Hotel Mitland, Utrecht, Netherlands £1,025.00 (€1,545.00) + VAT

25th - 26th November 2008

Honeyman Group Ltd, Barnard Castle, U.K.

£1,025.00 (€1,545.00) + VAT

Course Background
Engineers from all disciplines play a key role in the development and manufacture of pharmaceutical products, with involvement in the design, qualification and subsequent maintenance of the facilities, utilities and equipment necessary for the various stages of production. The application of Good Manufacturing Practices to engineering and technical activities is essential to ensure that a company manufactures products of the required quality.

The purpose of this course is to highlight how current GMP's are applied to pharmaceutical engineering and technical services to ensure facilities, equipment and processes are maintained to the highest possible standards expected by the Regulatory Authorities. This seminar will be suitable for both introductory training and as a refresher course for engineers already working in the pharmaceutical and related healthcare environments.

Course Programme
A key objective of the course is to ensure that delegates acquire the appropriate knowledge of the current engineering practices and technologies as they are applied within the pharmaceutical and medical device industries.

Subjects that will be covered include:

  • The role of engineering and the engineer in the pharmaceutical industry. Duties, responsibilities and the application of Quality Assurance principles to engineering services

  • Current international GMP regulations and regulatory requirements (EU, PIC/S, US-FDA) as they apply to engineering activities

  • Good Manufacturing Practices with respect to following key quality systems within the engineering environment

    • Equipment specification and selection (URS)

    • FAT's and SAT's

    • Risk Assessment and qualification requirements

    • Equipment qualification (DQ, IQ, OQ)

    • Retrospective qualification of existing installations

    • Technical change control - what constitutes a change and how it is managed

    • Planned preventative maintenance

    • Training of personnel

    • Contractors - selection and supervision

    • Controlled documentation and record keeping

  • The manufacturing environment, including current applicable clean room standard for sterile and non-sterile dosage forms (EU GMP Annex 1, ISO 14644)

    • System design considerations

    • Qualification parameters as built, in operation and routine requalification

    • Routine maintenance and calibration procedures

    • Risks and problems associated with clean room installation and operation

  • Services and utilities

    • Pharmaceutical high purity water systems (design considerations, qualification and routine maintenance and calibration)

    • Clean steam (design considerations, qualification and routine maintenance and calibration)

    • HVAC

    • Sterilisation Processes

    • GMP risks and problems associated with utility installations

  • Auditing and self inspection programmes for technical services

  • Instrumentation and controls

    • Control system validation

    • Data integrity

    • Computer system validation implications

    • Application of GAMP requirements

  • Cleaning and cross contamination and the impact upon engineering activities

  • Review of current regulatory concerns with engineering and technical activities

Who should Attend?
This course will be relevant for all personnel who are actively involved in engineering and technical services within the pharmaceutical and related health care industries. In particular, the following would benefit from this course:

  • Engineers who are new to the pharmaceutical industry and who may be involved with the design, installation, validation and routine maintenance of pharmaceutical equipment and utilities

  • Engineers currently working in the industry, as a refresher course

  • QA/QC and production personnel wishing to gain further insight into current Good Engineering Practices

Upon Course Completion, Delegates will:

  • Understand the regulatory framework for GMP and the role of the engineer in meeting quality objectives for pharmaceuticals (safety, efficiency, quality)

  • Understand current Good Manufacturing Practices as they apply to engineering and maintenance activities in the pharmaceutical industry

  • Have gained an overview of critical utilities, including water and steam and their impact on GMP compliance

  • Understand the principles of quality systems as they relate to engineering services

Course Tutors
Mark Thompson BSc (Hons), C. Eng. M.I.E.E.
Managing Director, Honeyman Group Ltd

Mark's engineering background in the pharmaceutical and medical device industries includes Eli Lilly, Rhone Poulenc Rorer and Smith and Nephew Medical. Specialising in sterilisation technology, engineering and microbiology, also having extensive regulatory compliance experience. Mark has trained thousands of people around the world and bases all of the training lectures on the practical experience of the Honeyman Group in these fields, so ensuring that the training is always up to date and built upon real life experiences.

Andy N Marshall CChem, CSci, MRSC, BSc
Technical and Quality Director, Honeyman Group Ltd
Trained as an analytical chemist, Andy joined Glaxo's Barnard Castle factory in 1990 and was involved with stability testing and formulation development before moving to Sanofi.  At Sanofi, he was involved with cleaning validation before becoming the Equipment Validation Manager.  Andy then moved to primary pharmaceutical manufacture with Chirex as the Validation Co-ordinator, and latterly as the Operational Quality Manager at the Dudley, Newcastle and Annan, Scotland sites for Rhodia Pharma Solutions (RPS) and Shasun Pharma Solutions (SPS).  Andy also spent a period of time in New Jersey, U.S.A. developing the quality systems for the newly acquired pilot plant for RPS.  Andy brings a broad range of validation (in both primary and secondary pharmaceutical manufacture) and quality assurance knowledge, including FDA and MHRA audit readiness activities and involvement.

Dr Arthur Bradley PhD, CChem, MRSC
Principal Consultant, Honeyman Group Ltd
With over thirty years working in the pharmaceutical industry, Arthur has experience across a range of areas and companies, including Glaxo, Cyanamid, and Fisons (subsequently RPR and Aventis).  He worked initially in analytical development, then chemical development, API product support and process development, prior to over twenty years experience in the pharmaceutical development area.  He has wide experience of the development and scale up of a range of products, including solid dose, suspensions, and sterile solutions, through pilot manufacture, to their implementation as routine validated production processes, both in the UK and overseas, in existing and new facilities.  He also had responsibility for the introduction of new technology for existing products and the inter site transfer of existing products.

Course tutors will vary dependent upon date and location.

Course Language
The course will be delivered in English.

The Venues
Tara Towers Hotel, Merrion Road, Dublin 4, Ireland
Tel: +353 (0) 1 269 4666,      Fax: +353 (0) 1 269 1027,     
Web: www.taratowers.com

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.

Honeyman Group Ltd, Barnard Castle, UK
Tel: +44 (0)1833 690101,     Fax: +44 (0)1833 690102,     
Web: www.honeyman.co.uk

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.

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

Pharmaceutical Water Systems   Sterilisation and Depyrogenation   Analytical Services and Testing 
Pharmaceutical Training Courses   Pharmaceutical Process Consultancy   GMP Regulatory Compliance

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