Pharma Internal Auditor course - plan, perform, report and follow up audits professionally

This course is specifically designed for auditors who perform internal audits in a pharmaceutical environment.

Designed for auditors who perform internal audits in a pharmaceutical environment

Do you perform, or are you about to start performing, internal audits?  If so, then this course is just for you.  On this course we cover how to professionally plan, perform, report and follow-up internal audits against GMP.  This course is aimed at new auditors who have had no formal training and will show them how to perform effective and efficient audits in a pharmaceutical environment.  Interested? Our two-day Pharma Internal Auditor course is available on the following dates:

Course dates Venue Click below to book a place
Tuesday 17th to Wednesday 18th October 2017 Reading, Berkshire, UK
Internal Auditor course

If you plan to pay by credit card then you should first look at this helpful information. Alternatively, if you want to discuss any aspect of this Internal Auditor course or want to reserve a place, please send an email with your enquiry or call +44 1635 866699.

 

Course overview:

This Pharma Internal Auditor course is designed for those new to auditing.  The course covers how to plan, perform, report and follow-up audits professionally.  Delegates will learn about GMP and how to audit against GMP (as a standard) as well as the newer requirements of Q10 (Quality Management) and the ramifications of this document to GMP, including recent updates to EU GMP Chapters 1 and 2.

Who will the course benefit?

Our Pharma Internal Auditor course is aimed at people who perform internal and external audits, people who manage audit programmes as well as individuals who host  auditors of their own organisation.

Course location:

UK courses (Reading, Berkshire)
The Holiday Inn – Reading South, 500 Basingstoke Road, Reading, Berkshire, RG2 0SL, UK. The hotel is very close to Junction 11 of the M4 – 25 miles west of London’s Heathrow Airport.
Telephone: + 44 (0)871 942 9067
e-mail: [email protected]
Web: http://www.hireadingsouthhotel.co.uk
A special rate of £121 (including VAT) has been agreed with the hotel (subject to availability). This is for Bed and Breakfast and includes internet access. Quote “Inspired Pharma” when making your booking.

Pharma Internal Auditor Course cost:

£1190  per delegate plus VAT. Course will be charged in GB pounds.

VAT will not be charged for courses held outside the UK. VAT will be charged for the courses held in the UK, however delegates from outside the UK but within the European Union (EU) will not be charged VAT if they supply their own company’s national VAT number when booking. VAT will not be charged for any delegates coming from outside the EU.

The cost of accommodation is not included in the course cost. If required you should book accommodation yourself directly with the hotel.

The cost includes:

  • Refreshments and lunch during the course times.
  • Course folder containing copies of slides and supplementary notes and handouts.
  • Course attendance certificate.
  • Full tutor support and access during course times.

Payment can be made by cheque, electronic transfer, credit or debit card. Payment must be made before the course start date. Either payment or a Purchase Order number will be required to secure a place on the course.

To book a place on our Pharma Internal Auditor course please use the online booking system by selecting the ‘Book Now’ button on the event of your choice (at the top of the screen/page)

Previous delegate feedback:

“Presented with great energy – I enjoyed this course” QA Officer, CATALENT

“Excellent course – I highly recommend to anyone involved in audits” Quality Administrator, DERMAL LABORATORIES

“Well delivered” Senior QA Officer, CATALENT

“Not an easy subject to make interesting – but you did it!” Compliance Manager, UCB PHARMA

“A great course delivered in a brilliant way” Product Development Manager, TEVA

“Passionate tutors and a very interactive course” Shift Manager, THORNTON & ROSS

“The great enthusiasm from the tutors made the course so interesting” QC Analyst, EISAI

“The best training course I have ever been on” Senior QA Officer, THORNTON & ROSS

“Excellent – I recommend to others” Manager, THORNTON & ROSS

“I liked the passion and commitment of both tutors” Team Leader, CATALENT

“Excellent – fantastic delivery” Stability Coordinator, CATALENT

“Fantastic” QA Specialist, TEVA

“Both presenters were excellent” Quality Systems Officer, TEVA

“A fantastic double-act” Product Development Manager, TEVA

“Thank you for providing me with more confidence” Senior Quality Specialist, JANSSEN-CILAG

“Fantastic” Head of Drug Safety, JANSSEN-CILAG

 Dates:

See top of this page for current public dates. Also available for in-house delivery, and may be customised if required.

Times: 

Day 1:  09.00 – 17.00        Day 2:  09.00 – 16.30

Tutors:

Peter Lavis

peter

Peter is arguably the finest Quality Management Systems tutor in the business, his enthusiasm for quality system thinking and his outstanding training abilities have gained him international praise and appeal. He is an IRCA registered Quality Management Systems Lead Auditor. Peter is an enthusiastic trainer with over 30 years of quality and industrial experience, including spending the past 15 years working closely with pharmaceutical organisations small and large.

Dominic Parry

dom

Dominic Parry has worked in the pharmaceutical industry since 1992, and is a leading pharmaceutical quality management specialist. He worked for 4 years at Evans Medical Limited (now Novartis Vaccines) as a Production Development Scientist. He then moved to Hoechst Marion Roussel (now Patheon, UK), where he worked for 4 years as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.Over the past 15 years he has worked as a leading pharmaceutical GMP trainer and Quality Management System specialist. He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems.He is generally recognised as one of the leading GMP trainers in the UK and brings an enormous amount of interest, enthusiasm and fun into the training he presents. He is Managing Director of Inspired Pharma Training Ltd.

Course contents:

Day 1     Quality Management Systems and auditing

  • Quality Management Systems and their evolution
  • GMP – structure and legal status
  • Types of audits and reasons for performing them
  • GMP requirements for internal and supplier audits
  • GMP and Pharmaceutical Quality Management development
  • ICH Q9 and 10
  • An overview of ISO 9001 and how many of its requirements are incorporated into ICH Q10
  • Effective audit planning and preparation

Day 2     The audit process

  • Review of documentation before the audit
  • Good auditing techniques
  • Checklist construction
  • The opening meeting
  • Audit role-play exercise
  • The closing meeting
  • Finding faults and identifying opportunities for improvement
  • Non-conformity reporting and corrective actions
  • Audit reports and post-audit activities