Pharmaceutical GMP

Monday, 19 March 2018
Pharmaceutical GMP
Monday, 19 March 2018 08:30 -
Thursday, 22 March 2018 13:00 (Central European Time)

DoubleTree by Hilton Amsterdam Centraal Station
+31 020 530 08004
Oosterdoksstraat, Stadhouderskade 12
1011 DK

Map and Directions


It is a legal requirement that all staff receive regular training in Good Manufacturing Practice.

This course is designed to provide you with up-to-date knowledge of new and impending Good Manufacturing Practice regulations and current ‘hot topics’.

Europe’s Most Popular GMP Course!

  • In the last nine years, over 1000 delegates from all over Europe have attended this very popular course
  • This course repeatedly achieves the highest customer satisfaction level of any of our courses, with 95% of delegates rating it “very good” or “excellent”
  • This course now forms an entry level GMP training requirement for our very popular Pharmaceutical Quality Management Systems Auditor/Lead Auditor Training Programme

Course Outline

Why we have good manufacturing practices

EudraLex Volume 4 (A copy of EudraLex Volume 4 is provided and is used as the basis of this course)
  • Structure
  • Content
  • Application
A clear comparison of EU and FDA GMP requirements
  • Areas of agreement
  • Critical differences
Up-to-the-minute information on new good manufacturing practices initiatives and regulations
  • FDA’s cGMP for the twenty-first century
  • Changes to EU GMP regulations…
    • Product Quality Review
    • Ongoing Stability Testing – reference samples and retention samples
  • ICH Q9: Quality Risk Management
Practical advice on dealing with the ‘difficult areas’ of good manufacturing practice
  • Change control
  • Deviations
  • Assessing the effectiveness of training
An understanding of how GMP is influenced by…
  • Premises
  • Processes
  • Products
  • Procedures
  • People
An appreciation of the critical good manufacturing practice issues for…
  • Solid dosage forms
  • Sterile products
  • Liquids/semi-solids
  • Packing operations
  • Computers
A panel discussion session to explore YOUR specific GMP problems

Course Tutors

  • David Waddington
  • Samantha Clack

The start and finish times given are approximate, please contact our office for further information.


Contact Details

Payment Instructions

  • Payment Methods

    Please note that for customers outside Europe we can only accept credit card payments, we do not accept purchase orders.

    By Bank Transfer 
    — We are happy to accept payment directly into our bank account so long as:

    • a purchase order number is provided (if required my your company)
    • the full amount of the invoice is received net of all local and UK bank charges at least 10 working days prior to the course start date
    • a remittance slip giving clear details of our invoice number is received at this office to coincide with the payment being credited to our bank account

    Our bank details:

    Account No.: 50144499 – Sort Code: 60-16-30

    IBAN: GB38NWBK60163050144499


    By Credit or Debit Card — Using Regonline Secure Payment facility. The total purchase price (including VAT if applicable) and service charge will be displayed prior to confirming the order.

    VAT Invoice — A VAT invoice (if applicable) will be provided (VAT Reg No. GB 663 2419 39).

    Cancellations — Written cancellations with a full refund will be accepted up to 25 working days before the start date of the course. A fee of 50% will be payable for cancellations received between 10 and 25 working days before the start of the course. Full course fees will be charged for cancellations received within 10 working days of the course start date. Delegate substitutions may be made at any time up to the start of the course. Refunds will be made within 30 days of receiving the written cancellation by the same method that payment was made.

    Late Payment Clause

    We understand and will exercise our statutory right to claim interest at 2.5% above the prevailing Bank of England base rate under the Late Payment of Commercial Debts (Interest) Act 1998 if we are not paid according to our agreed credit terms.

    The programme and other information contained on this website are correct at the time of publishing and are published in good faith. We reserve the right to make any changes which may become necessary.

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