Monday - Friday
28 Nov - 2 Dec 2016
 
Day 1: 8.30am - 6.30pm
Day 2: 8.15am - 6.30pm
Day 3: 8.15am - 6.30pm
Day 4: 8.15am - 5.30pm
Day 5: 8.30am - 1.00pm  
Marina Mandarin Singapore
6 Raffles Boulevard
Marina Square
Singapore 039594
Effective Pharmaceutical Audits & Self-Inspections PQMS Auditor/Lead Auditor Course A17638
ISPE Singapore Affiliate is pleased to invite you to an exclusive IRCA Certified Auditor Training, in conjunction with NSF Health Sciences Ltd, from the UK. This is a unique opportunity, which can lead to Lead Auditor/Auditor Certification with IRCA, saving time and travel expenses. (The UK course fees alone are over GBP 2,750).
 
Please note that the number of attendees for this training course is strictly limited to 20 attendees, according to IRCA guidelines.
We strongly recommend that you reserve your places as soon as possible, to avoid disappointment.
 
Following is a brief write-up about the trainers and links with detailed information on the course.
This is the first truly independently  certified pharmaceutical GMP auditor course    available 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 5 day course will provide education, training and development for auditors to meet these continuing pressures and fulfil this critical role.
Why should I attend this training?
  •  The course tutors are the best available, globally:
    • They all have between 20 and 40 years' hands on experience in the manufacture and quality assurance industry and between them cover virtually every dosage form. They really understand the pressures you face.
    • All our tutors are excellent presenters and very experienced in training those where English isn't their first language.
  • NSF has worked with over 300 companies in 35 different countries so they have an exceptional understanding of global standards and best industry practice.
  • NSF is recognised as Europe's leading provider of training for Qualified Persons (QPs); its series of QP training modules has been running for over 20 years.
  • NSF designed and developed the IRCA GMP Lead auditor scheme and provided scheme certification materials to IRCA for general use.
  • NSF has also trained regulatory auditors from over 7 regulatory agencies.
  • They provide you with more than the slides, though their course materials are some of the most detailed and comprehensive available.
  • The courses are designed to appeal to every 'learning style' including kinaesthetic, auditory and visual. They do not believe in 'death by PowerPoint'.

After each course, NSF will provide you with ongoing support, via email or telephone, free of charge. 

 
The Trainers
Mr Mike Halliday 
BSc (Pharm), MRPharmS, PGDip

  • Executive Director, NSF Health Sciences - Member of the Royal Pharmaceutical Society of Great Britain Member of the Industrial Pharmacist Group
  • Qualified Person by assessment via the permanent provisions of EU Directive 75/319/EEC
  • Extensive pharmaceutical manufacturing management and QA experience gained over 20 years working for three major international pharmaceutical manufacturers culminating in the post of Associate Director - Global Audit and Compliance for Wyeth Europa 
  • Broad experience with the manufacture of a wide range of parenteral and non-parenteral dosage forms
  • Extensive experience in international QA auditing of a wide range of pharmaceutical manufacturers of most dosage forms and specialist distributors in Europe, Middle East, America and Asia Pacific
  • International experience with factory management and new factory start up and validation Project management experience with technology transfer
  • Honorary lecturer at the University of Strathclyde
Mrs Liz Allanson 
BSc(Pharm), MRPharmS
  • Qualified Person under the Transitional Provisions since 1985
  • ISO 9001 Lead Auditor since 1993 
  • Held roles including Manager and Inspector, GMP Inspection unit at UK Medicines and Healthcare products Regulatory Agency (MHRA) from 1986 - 2004 
Testimonials
This course has given me lots of exposure and allows team discussions, presentations and exercises, which makes it much more interactive and interesting.
Teo Jing Sian, Roche Singapore

Engaging training. Pace is just right. Trainers are very knowledgable.
Wang Xinqiao, GSK

Very well organized and informative. Vey professional tutors.
Ya-Ting Hsieh, Yung Shin Pharma

Very well structured training and trainers.
Shirley Chia, Novartis Singapore Pharmaceutical Manufacturing
Registration Fees
 
Member
Non-member
Early Bird*
S$5,395
S$5,995
Regular
S$5,995
S$6,295
 
*Early Bird Deadline 15 July 2016

If you have any questions or need assistance with your registration, please contact Kristina Autenrieth at ispesingaffiliate@gmail.com . 

Organized by:                                                    In Conjunction with: