Effective Pharmaceutical Audits and Self-Inspection (An IRCA Certified Pharmaceutical QMS Auditor Course)

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

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

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

Certification

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

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

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.

• 

  Mrs Liz Allanson
  Consultant
  BSc (Pharm), MRPharmS

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

  Dr David Selby
  Consultant
  BSc, PhD, MCQI

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

What you've said

“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

“Tutors ran the course at a good pace with lots of interaction which helped in focusing on the material and retaining the information.”

Adam Hughes, Baxter Healthcare, UK

“One of the best training courses I have ever been to!! The mix of lectures, teamworks and presentations was very good and gave a lot of opportunities to practice and discuss with other participants. Very competent trainers.”

Kicki Garheden Fredriksson, Octapharma AB, Sweden

“I have benefitted from the course content and syllabus but more importantly from the profound experience and valuable anecdotes and examples from the three tutors.”

Poh Ewe Tan, Roche Singapore Technical Operations, Singapore

“The tutors are very professional! I enjoyed learning from them and their experiences! Thank you!! Although the course was very intensive I will recommend it to my colleagues.”

Chen Friedlis, Dexcel Pharma, Israel