GMP for Biological and Biotechnology Products

Manchester, UK
Tuesday, 27 February 2018
GMP for Biological and Biotechnology Products
Tuesday, 27 February 2018 08:30 -
Friday, 02 March 2018 13:00 (GMT)

Hilton Deansgate Manchester Hotel
EU,HS,BIO,BIO,BT,GM,SP,CR
303 Deansgate
+44 (0) 161 870 1600
Manchester
UK
M3 4LQ
United Kingdom

Map and Directions

       

 The development of new biopharmaceuticals and biotechnology products promises to bring about a revolution in global healthcare. However, the manufacture and control of such products brings with it special concerns and challenges which, if inadequately addressed, could jeopardise product quality and patient safety.If companies are to be successful in this highly important arena, it is essential that staff at all levels clearly understand…
  • The risks and challenges associated with biopharmaceuticals manufacture and control
  • The rapidly changing international regulatory demands and expectations for these products
  • How these requirements can be translated into a practical, effective and cost-effective quality management system
All these issues and more will be addressed in this introductory three-day training course.

What You Will Learn

  • Current EU and US regulations and expectations for the manufacture of biopharmaceuticals for commercial and clinical trial use
  • Key GMP compliance issues for the different stages of the manufacturing process…
    • cultivation
    • QC
    • downstream processing
    • shipping
    • fill and finish
    • key issues of importance to the Qualified Person

Course Outline


Regulatory Issues

  • US and EU regulatory frameworks for biopharmaceuticals
  • Current GMP regulations, guidelines and ‘hot topics’
Premises and Plant
  • Fundamental design concepts and segregation
  • Specific requirements for multiproduct facilities
  • Environmental classification and monitoring
Starting Materials
  • Sampling and testing requirements
  • Supplier certification
  • GMP requirements for cell banks/seed lots
Specific GMP and Validation Requirements for…
  • Cultivation and harvest
  • Purification
  • Virus and DNA clearance
  • Cleaning
  • Equipment sterilisation and decontamination
  • Shipping
Quality Control Aspects
  • Specific requirements for bioassays
  • Control of standards and reference materials
  • Handling OOS and OOT results
Quality Management
  • Essential elements of a quality management system for biopharmaceuticals
  • Handling deviations and CAPAs
  • Change control
Key Issues for the Qualified Person
  • The technical agreement
  • Audit expectations
  • Involvement in deviations
  • The batch review process

Course Tutors

  • Stewart Green
  • Terry Snape

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

    SWIFT: NWBKGB2L


    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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