Effective Pharmaceutical Audits and Self-Inspections

About this course

This is the first truly independently certified pharmaceutical GMP auditor course available across Europe, and now globally.

Pressure on the pharmaceutical industry to audit has never been higher and continues to increase. Supply chain decisions and batch release decisions are being made based on audits and self-inspections. As a result, a high level of scrutiny is being placed on the training and development of auditors and self-inspectors.

Decisions are being made covering:

• Approval of suppliers
• Approval of contractors
• Acceptability of in-house practices and procedures
• Overall regulatory compliance status

Auditor skill and competency are critical to making the right decisions. This course will provide education, training and development for auditors to meet these continuing pressures and fulfil this critical role.

What You Will Learn

• The difference between an average auditor and a great auditor
• How to structure, plan and manage an audit and self-inspection programme or system
• How to use risk assessment to set audit priorities and rank observations
• How to use and develop the auditor’s technical and non-technical skills, competencies and personal attributes to provide a toolkit of key auditing skills
• Technical guidance through current hot topics from years of top level audit experience
• Effective questioning techniques
• Reviewing data
• Techniques used to train inspectors from world renowned regulators
• How to prepare for and conduct your best audit ever

Who Should Attend

• Anyone involved in the management and conduct of internal and external audits and self-inspections
• Those who have to face auditors and want to be aware of the processes
  and techniques being applied
• This will include:
  • Qualified Persons
  • Auditors old and new
  • Quality Assurance
  • Self-inspectors

Course outline

• The course assumes experience and working knowledge of GMP guidelines in the region the auditor is working (EudraLex Volume 4 or US CFR 21), or previous attendance at an NSF-DBA four-day Pharmaceutical GMP course
• The course follows ISO 19011 guidelines for quality and management systems auditing
• The course is prepared using pharmaceutical industry standards including:
  • ISO 9000
  • IPEC guides
  • PS 9000
  • GMP
  • Industry Standards of ICH
    with special emphasis on the Quality Management System and ICH Q10

Principles and audit planning

• Planning and preparation
• Audit types and techniques
• Establishing an audit programme for suppliers, contractors and company sites
• Internal vs external audits
• The audit process

Auditor skills and competencies

• What makes a good auditor
• Communication skills – questioning and listening
• Body language and non-verbal communication
• Overcoming apathy, resistance and aggression
• Effective note taking
• Auditor continuing professional development
• Assessing the auditor

Initiating, preparing and conducting the audit

• Materials management
• Documentation systems
• Sterile products
• Oral solid dose
• Packaging
• Laboratories
• and many more

Concluding the audit

• Wrap up
• Follow up

For further information, please contact Gill Gibbeson by telephone +44 (0) 1751 432999, or email [email protected]

To book a place, please follow the ‘book now’ link on the right of your screen or contact [email protected]

Discussion and Working Groups

This course meets the training requirements for the new IRCA (www.irca.org) Certification of Pharmaceutical Quality Management Systems Lead Auditor (PQMS).

The course is highly interactive and takes the form of a mock or virtual audit.

Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.

Venue

Renaissance Karlslruhe Hotel, Germany

This city center hotel is close to the convention center and offers easy access to the fair grounds. Enjoy a stroll to the Karlsruhe Castle, only 10 minutes away. Visit many local area attractions including the Black Forest, Baden-Baden with its’ world famous casino and grandiose spas.

The Karlsruhe hotel offers comfortable guest accommodation with luxurious bedding, a large work desk and wireless HSIA. For added comfort, choose a spacious suite with living area and a walk-in closet. You can dine in their typical Baden-style Restaurant “zum Markgrafen” serving regional German cuisine with a contemporary twist and test your wine expertise at their exclusive wine-tasting station.

Hotel Accommodation

• We have a block booking of bedrooms at the Renaissance Karlslruhe 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

All our presenters have extensive industrial and, in some cases, regulatory agency experience. We are fully up-to-date with the very latest international regulatory and GMP compliance requirements and we have the experience to help you meet the challenges of auditing diverse topics and facilities in the pharmaceutical arena.

• 

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

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

  Mrs Liz Allanson
  Consultant
  BSc (Pharm), MRPharmS

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

What you've said

“A lot better understanding of ICH Q10! Overall understanding of auditing process is now a lot better. This course indicated clearly on which areas I personally need to improve.”

Paivi Waris, Santen Oy, Finland

“An excellent course with well-presented material by highly knowledgeable tutors. The opportunity to take part in a mock audit closing meeting was extremely valuable.”

Matthew Scarff, Rosemont Pharmaceuticals Ltd, UK

“Very pleasant, intensive course in a nice open atmosphere. Learnt a lot, very enthusiastic.”

José Houtman, Allione Consultancy, The Netherlands

“The chance to learn from very experienced tutors is very, very, valuable! Excellent experience.”

Richard Anspach, Aluglas BV, The Netherlands