Formulation & Processing Part 2 - QP Module

York
Monday, 09 March 2015
Formulation & Processing Part 2 - QP Module
Monday, 09 March 2015 08:30 -
Friday, 13 March 2015 15:00 (GMT)

Hilton York Hotel
EU,HS,BIO,QP,AS,CR,Q3
+44 (0)1904 648 111
1 Tower Street
York
YO1 9WD
United Kingdom

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Once a new chemical entity has proved its potential in clinical studies, the challenge begins to formulate the compound into an effective medicine and to manufacture that medicine reliably so that safety, quality and efficacy are assured.

This module addresses the two important activities of formulation and processing and provides key information on…
  • How the physico-chemical attributes of the drug and the therapeutic indication influence:
    • route of administration
    • dosage form
  • Assuring bioavailability
  • Methods of manufacture of the major dosage forms
  • Factors affecting suitability for use of the major dosage forms
The Qualified Person, and other key technical personnel, MUST have a detailed understanding of these topics if they are to…
  • Assist in the design and implementation of relevant, effective quality systems for dosage form manufacture
  • Contribute to the RISK ASSESSMENT process for processing changes and unplanned deviations
  • Assess the adequacy of cleaning strategies
  • Assess the potential impact of changes to physical and chemical attributes of starting materials
This, therefore, represents one of the key modules in this series.

Course Outline


Parenteral Products

  • Routes of administration
  • Formulation considerations
  • Major processing methods
  • Critical process steps
  • Key GMP requirements
Inhalation Products
  • The respiratory route of administration
  • Formulation considerations
  • Major processing methods
  • Critical process steps
  • Key GMP requirements
Topical Products
  • The dermal route of administration
  • Formulation considerations
  • Critical process steps
  • Key GMP requirements

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, provide delegates with an opportunity to obtain answers to their specific questions and concerns.

Course Tutors

  • James Johnson, University of Strathclyde, UK
  • Alex Mullen, University of Strathclyde, UK
  • Mr Martin Lush, NSF Pharma Biotech Vice President

Why This Training Will Benefit YOU:

The Aspiring Qualified Person
  • This series of 12 modules held over a 21 month period has been carefully designed to meet the requirements for theoretical training detailed in the latest UK Qualified Person Study Guide and EC Directives 2001/82/EC and 2001/83/EC.
  • All our training courses provide practical, face-to-face tuition in sufficient depth to prepare you fully for the challenges that lie ahead.
  • Our training is generally considered as the best available and our QPs are held in high regard within the industry.
  • As well as being accepted in the UK, our training courses are well known and accepted by several other EU countries, including Ireland, The Netherlands, Austria, Hungary and Malta.
  • You are more likely to become a QP with us than with any other training provider!

The Pharmaceutical Technical Professional
  • Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers within other areas of pharmaceutical manufacture and control.
  • Increasingly, companies are using these modules as part of a modular technical and professional development plan for their staff.
  • Additionally, many industry professionals attend the courses as part of their Continuing Professional Development.
  • This course is designed to lead to Postgraduate Certificate, Diploma and MSc qualifications depending on modules taken and work commitment by students. For further details, please contact Stella Pearson-Smith, our QP Course Administrator at QPpharma@nsf.org for more information

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 the European Union (EU) 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:
    • 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.The total purchase price (including VAT if applicable) and service charge will be displayed prior to confirming the order.

    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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