Pharmaceutical GMP Auditor/Lead Auditor

Course Overview:

This is a unique training course for pharmaceutical auditors who will audit against pharmaceutical Good Manufacturing Practice (GMP) and/ or audit suppliers to pharmaceutical manufacturing sites. The course trains auditors how to professionally plan, perform, report and follow-up internal and supplier audits and is set in a pharmaceutical context throughout the whole course.

The Pharmaceutical GMP Auditor/Lead Auditor Course covers the requirements of European Union GMP (EU GMP), including the requirements of ICH Q9 and 10, and how these are used as the main reference base when auditing pharmaceutical manufacturing sites. Also included in the course is an overview of key standard for suppliers to the pharmaceutical industry, including ISO 9001, Active Pharmaceutical Ingredient GMP (API GMP), Excipient GMP, Packaging Supplier Standards as well as Good Distribution Practice (GDP) and how these should be used when auditing suppliers.

The course explains the role of the auditor to professionally audit a modern Pharmaceutical Quality Management System (PQMS) and on successful completion of the course can be used as part of registration with IRCA (see later) to become an internationally accredited pharmaceutical auditor.

The Pharmaceutical GMP Auditor/Lead Auditor Course covers the principles of auditing Pharmaceutical Quality Management Systems (PQMS) as detailed in GMP and also the FDA’s “Guidance for Quality Systems” and ICH Q10 “Guidance on Pharmaceutical Quality Systems” as well as the requirements of EU GMP itself. During the course there are many exercises and workshops to put the lessons learnt into practice. There is also a final examination at the end of the course.

Name change – please note that the official name of this course has been changed by IRCA. This course used to be called a “Pharmaceutical Quality Management Systems (PQMS) Auditor/ Lead Auditor training course.

Who will the course benefit?

Internal and supplier auditors along with key personnel involved in Quality Assurance and Quality Management Systems. The course is also ideal for trainee Qualified Persons (QPs) as well as existing auditors who have had no formal auditor training. The course is also used as part of Continual Professional Development (CPD) of many quality professionals.

So that we can give the delegates the right amount of time and attention – we limit this course to a maximum of 12 delegates.

Pre-course knowledge:

It is recommended that attending delegates have an appreciation of the standards covered during the course, but this is not essential. This includes knowledge of the requirements of ICH Q10 (plus ICH Q8 and ICH Q9) and a basic knowledge of Eudralex Volume 4 (European Union GMP).

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: reservations@hireadingsouth.com 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.

IRELAND courses (Dublin) The National Institute for Bioprocessing Research and Training (NIBRT), Fosters Avenue, Mount Merrion, Blackrock, County Dublin, Ireland Telephone: +353 (0) 1 215 8100 e-mail: info@nibrt.ie

For directions and hotel details please visit NIBRT’s own website (details below). The Radisson Blu hotel is within walking distance of the course venue.

http://www.nibrt.ie/contactus

Course cost:

£3295 (approximately €3700) 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. It is recommended that delegates stay at or close to the course venue.

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.
• Additional support given where needed.
• Your own personnel copies of the main standards covered during the course, including:
• EU GMP • USA GMP • API GMP • Excipient GMP • Good Distribution Practice • Good Distribution Practice for active ingredients • ICH Q9 and 10
• Examination fees.
• Free examination re-sit and additional coaching (if needed) on the next public course.

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.

Course Times:

This is an intensive course with assessments throughout. The timings are as follows:

Day 1: 09.00 – 18.45 Days 2, 3 & 4: 08.30 – 18.30 Day 5: 08.30 – 16.30 (includes final examination)

There is also about an hour’s evening work each night.

Tutors:

Peter Lavis arguably the finest Quality Management Systems tutor in the business, Peter’s enthusiasm for quality system thinking and his outstanding training abilities have gained him international praise and appeal. Peter is a leading quality management systems auditor and encourages auditors to think outside the “GMP box”.

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.

The tutors have now trained over 800 delegates on IRCA registered Pharmaceutical Lead Auditor training courses.

Course accreditation:

This course is approved by IRCA (The International Register for Certificated Auditors) and meets their current PQMS Auditor/ Lead Auditor training course requirements. On successful completion of this course delegates may begin registration with IRCA as an internationally recognised auditor of Pharmaceutical Quality Management Systems (PQMS). IRCA course reference number – A17632.

This course is also based on current Pharmaceutical Quality Group requirements for training pharmaceutical Auditors/ Lead Auditor to audit against a range of pharmaceutical supplier standards.

Assessment:

Delegates are assessed by continuous assessment throughout the course and a final examination. Our final examination success rate is currently 95%. The IRCA average success rate for standard Lead Auditor courses is 76.5%. In the event of failing the final examination we offer free support and a free examination re-sit.

Course contents:

Quality Management Systems:

• The latest FDA and EU GMP thoughts on Quality Management Systems.
• The requirements of GMP, ISO 9000 and their inter-relationship
• The structure and legal status of EU and USA GMP
• GMP and Quality Management
• The requirements of GMP and the importance of product quality and the patient
• Performing audits to GMP
• Auditing the Warehouse, Production, Packaging and Laboratories
• Auditing systems – Training, Internal Audits, Management Review, Deviations, Complaints, CAPAs
• The importance of getting to the root-cause of the problem

Auditing suppliers:

• Supplier standards (API GMP, Excipient GMP and Packaging Suppliers Standards)
• The Falsified Medicines Directive and Good Distribution Practice
• The evolving role of Quality Assurance – thinking about more than product quality
• The enhanced role for Senior Management within a Pharmaceutical Quality Management System
• ICH Q8, 9 and 10 and their role in a modern forward thinking pharmaceutical company
• Using audits to promote continual improvement
• Thinking beyond GMP and product quality – business quality and performance
• Organisational efficiency, effectiveness and continual improvement

Auditing:

• Reasons for first, second and third party audits – using them effectively
• How to plan, execute, report and close-out internal and external audits
• Opening and closing meetings
• Auditing Senior Management and their commitment to the system
• How to perform audits professionally
• Audit role-play exercise – with pharmaceutical facility video and over 300 documents and records to review
• Auditing functions, departments and processes
• Good auditing techniques
• Checklist construction
• Auditing for compliance to GMP
• Getting to the root-cause of a problem
• Adding value as an auditor
• How to conduct audits that promote increased process performance
• ISO 19011 guidelines for quality and management systems auditing

To book your place:
Please email to reserve a place or call +44 1635 866699 quoting "Clarity Compliance"

Please contact enquiries@clarity-compliance.com for more information.

Please take a look at our range of scheduled 'Open Forum' training courses