How to Audit - Bulk Biotech Operations

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. With 151 stylish guest bedrooms the hotel is ideal for the business or social traveller.

Secure WIFI internet access is available in public areas and their recently refurbished Leisure Club features a heated pool, sauna, steam room, jacuzzi, gymnasium and private tennis court.

Hotel Accommodation

Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
To take advantage of this offer, you must book via a special weblink, details of which are provided under the ‘Hotel Bookings’ section at the bottom of this page.
This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
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.

Venue Address and Contact Details

York Marriott Hotel
Tadcaster Road
York
YO24 1QQ
England

Tel: +44 (0) 1904 701 000
Fax: +44 (0) 1904 702 308

Hotel Bookings

If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following this link

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:

Dr Terry Snape
Consultant
BA, PhD, CChem, MRSC
- [email protected]
- +44(0)1751 432999

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