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About this course

At NSF-DBA we appreciate the enormous breadth of knowledge that is required to be a pharmaceutical auditor. It is a job that requires a range of skills related to organisation, report writing, managing vendors and time keeping. Add to this the fact that within the pharmaceutical arena the auditor is expected to know all about each dosage form and the CFRs and EudraLex inside out, from Clinical Manufacture to Distribution and beyond.

We know the challenges because here at NSF-DBA, through our contract auditing services, we are fortunate enough to work with a group of industry experts who have the appropriate range of skills; we are continually working to fit the right person to the job, to enable us to produce the standard of work the client expects.

We believe that this same group of experts can help you to develop your auditing skills and product knowledge, so we have put together a series of ‘How to Audit’ courses that will help you perform your audits with the correct understanding of the topic and the regulatory expectations relating to that topic.

Our Effective Pharmaceutical Audits and Self-Inspections course is certified by IRCA as a Pharmaceutical Quality Management System lead auditor training course. To follow on from this or to supplement existing auditor training, there is a clear need for auditors to demonstrate Continuing Professional Development.

So if your audits are taking you into less familiar areas, consider in depth training in a range of four and five day CPD courses, for example:

• Steriles
• Pharmaceutical Microbiology (QP4)
• Formulation and Processing (QP3)
• Quality Management Systems (QP8)
• Biotech

If you are familiar with the subject matter, but want to explore:

• Standards
• Industry norms and best practices
• Designing audit plans
• Evaluating observations
• Personal Q&A and tutoring

then consider the shorter ‘How to Audit’ courses.

Course outline

Information to follow

Venue

York Marriott Hotel, York, UK

The York Marriott Hotel is within walking distance of York city centre
and its many attractions including the National Railway Museum and
York Minster. Castle Howard, the Yorkshire Dales and the North
Yorkshire Moors are within a 1 hour drive of the hotel. With 151
stylish guest bedrooms the hotel is ideal for the business or social traveller.

The hotel offers a range of banqueting rooms holding up to 190 delegates theatre style, secure WIFI internet access is available in public areas and our recently refurbished Leisure Club features a heated pool, sauna, steam room, Jacuzzi, gymnasium & private tennis court.

The all new Chase Bar & Grill serves a varied menu and offers a wide
choice of refreshments whilst offering unrivalled views of York
Racecourse from its sun terrace. The York Marriott’s recent accolades
include retaining the BDRC Best Conference Venue in Yorkshire
Award for 2008 (for the 3rd year in succession), as well as winning
the highly coveted York Tourism Bureau Award for Hotel of the
Year 2009.

Hotel Accommodation

• We have a block booking of bedrooms at the York Marriott Hotel, at a specially negotiated bed and breakfast rate per delegate per night.
• As part of our improvements to the booking process, we have arranged for an online booking service with the hotel and details of how to make your accommodation booking will be included in your course joining instructions (issued to you at the time of booking). Alternatively you will be able to make a telephone booking directly with the hotel. If you need any help or guidance with the accommodation booking process, please contact our course administration team.
• Your account with the hotel should be settled at check out.
• Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our experts for this course are:

• 

  Mr Mike Halliday
  Partner
  BSc (Pharm), MRPharmS, PGDip

  • [email protected]
  • +44(0)1751 432999

What you've said

Information to follow