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
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.
Course outline
- The course assumes experience and working knowledge of GMP guidelines in the region the auditor is working in (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
Discussion and Working Groups
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.
Venue
Belmont Square Conference Centre, Rosebank, Cape Town, South Africa
Belmont Square is a multi-function conference, seminar and exhibition centre, which offers professional, state of the art conference and communications equipment.
Positioned in the well-established, historical area of Rondebosch, Belmont Square is easily accessible by both road and rail. By train, the centre is 10 minutes from the Cape Town City Centre, and a mere 15 minutes by road from Cape Town International Airport.
The complex offers a spacious, safe and secure parking area, with additional free parking a short block away. Local accommodation too, is ideal. Five major hotels, and many upmarket bed and breakfast establishments, are situated nearby.
For assistance in finding accommodation please contact the Course Convener, Dr A J Thomas on [email protected]
For further information please visit the conference centre’s own website at “ www.belmontsquare.co.za “: http://www.belmontsquare.co.za or email them at [email protected]: [email protected]
Catering
During the course, mid-morning tea plus snacks will be served at approximately 10.00 with afternoon tea served at 15.00. At lunchtime you can enjoy an appetising finger buffet.
After each day’s activities a closed bar service will be available, chargeable to your account where relevant.
Special Dietary Requirements
If you have any special dietary requirements, please contact the conference management.
Venue Address and Contact Details
Belmont Square Conference Centre, Belmont Road,
Rondebosch, Cape Town, 7700
PO Box 382, Rondebosch, 7701
Tel: 021 685-2625
Fax: 021 685-2622
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:
What you've said
Feedback received for this course in Europe
“Thank you for a great time. The training was great, very professional, well planned and well delivered. Thank you again.”
Aga Sufin, Novartis Grimsby, UK
“A really excellent course! It was one of the most active and intensive weeks but I do not regret it at all.”
Tomasz Zawislak, Pharmatiqa Consultants, Poland
“Excellent content and organisation. Good mixture of lectures, activity sessions and sharing of real life experiences. Very useful role play sessions.”
Susan Marlow, Patheon UK, UK
“Tutors run 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, teamwork and presentation was very good and gave a lot of opportunities to practice and discuss with other participants. Very competent trainers.”
Kicki Garhedenn 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 tutors.”
Poh Ewe Tan, Roche Singapore Technical Operations, Singapore
“Got exactly the essential information and training I needed – can’t wait to use it!”
Alan Sarup, Orifarm Generics A/S, Denmark
“Excellent content and lectures as usual.”
Chris Unwin, Dr Reddys Laboratories, UK
“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
An NSF International Company
