A-Z of Sterile Products Manufacture

Amsterdam
Monday, 29 September 2014
A-Z of Sterile Products Manufacture
Monday, 29 September 2014 08:30 -
Thursday, 02 October 2014 15:00 (Central European Time)

Amsterdam Marriott Hotel
UK,HS,BIO,STE,BT,PM,SP,CR,STEA
+31 20 607 5555
Stadhouderskade 12
Amsterdam
1054 ES
Netherlands

Map and Directions

       


Sterile products manufacture represents the most hazardous activity (to the patient!) performed by pharmaceutical companies.

This is why it attracts so much regulatory scrutiny!

Recent regulations and guidelines from EU (Annex 1) and FDA ‘Sterile Drug Products Produced by Aseptic Processing’ are confusing to many and very difficult – and expensive – to comply with in full.

This course is designed to help you comply with these and other documents in a way that is…
  • Practical
  • Scientifically sound
  • Cost-effective
This is by far the most popular of our courses – hundreds of people attend it every year, either through this residential course or via courses run in their companies – and delegate feedback is excellent!

What You Will Learn

  • Current EU and FDA requirements for…
    • design and qualification of cleanrooms
    • environmental standards for controlled environments
    • control of key utilities
    • sterilisation processes
    • process simulations (media fills)
    • inspection and integrity testing
  • How to satisfy these expectations in a practical way
  • How to identify the root cause of any problem… and make the right risk-based decision!
  • The influence of FDA’s ‘PAT’ initiative on aseptic processing

Course Outline

Current Standards and Regulatory Requirements
  • ISO 14644
  • EU GMP Guide Annex 1
  • FDA Guideline ‘Sterile Drug Products Produced by Aseptic Processing’
The Cleanroom
  • Design
  • Qualification
  • HVAC systems and HEPA filter selection
Alternatives to Conventional Cleanrooms
  • Isolator technology
Critical Utilities
  • Steam – generation and quality expectations
  • Water – generation, storage and control
Sterilisation Processes
  • EU and US expectations for…
    • steam sterilisation
    • dry heat sterilisation
    • filtration
  • Other sterilisation processes
    • ethylene oxide
    • irradiation
    • vaporised hydrogen peroxide
Environmental Monitoring
  • Monitoring techniques
  • Designing an effective monitoring programme
  • Setting alert and action levels
  • Data management
Process Simulations (Media Fills)
  • Understanding the strengths and weaknesses of the media fill
  • Current regulatory expectations
  • How to demonstrate compliance
Disinfection Practices
  • The importance of TACT
  • Selection of disinfectants
  • Validation of disinfection procedures
Container Integrity Testing and Particulate Inspection
  • Methodologies
  • Strengths and weaknesses
  • Regulatory expectations
People Issues
  • Gowning and gowning practices
  • Qualification of cleanroom operators
  • Good aseptic practices
Problem Solving and Troubleshooting Tools and Techniques

Course Tutors

  • John Johnson
  • Darren Jones
The start and finish times given are approximate, please contact our office for further information.


 

Contact Details

Payment Instructions

  • Payment Methods

    By Bank Transfer — We are happy to accept payment directly into our bank account so long as:
    • the full amount of the invoice is received net of all local and UK bank charges within 30 days from date of invoice
    • the payment timescale quoted at the bottom of our invoices is strictly adhered to
    • 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 will be sent with the invoice.

    By Cheque — Payment should be made by sterling cheque drawn on a UK bank and payable to NSF Health Sciences Ltd. Please ensure that the full invoiced amount, net of all local and UK bank charges, is received within 30 days from date of invoice. 

    Please note that, in both cases, if any bank charges are deducted prior to receipt, this amount will be re-invoiced to yourselves.

    By Credit or Debit Card — Using Regonline Secure Payment facility.

    Payments — A VAT invoice (if applicable) will be provided (VAT Reg No. GB 927 3679 85). Settlement must be received at least 10 working days prior to the course start date. Cancellations within 25 working days of the course start date are subject to charges (see Cancellations section below). If a Purchase Order number is necessary to effect settlement of our invoice, please provide.

    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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