Good Distribution Practice

About this course

For many years, regulatory agencies have demanded that temperature sensitive products be stored and distributed under conditions which maintain the safety and efficacy of those products to the patient. This has led to so-called ‘cold chain’ best practices and guidelines.

Maintenance of the ‘cold chain’ is essential for products such as vaccines and other biopharmaceuticals. The effectiveness of the cold chain is a major area of concern during regulatory inspections and adverse inspection observations are common.

More recently, however, regulators have broadened the emphasis of temperature control to include all products where defined temperature bands exist, including so-called ‘room temperature’ or ‘ambient temperature’ products.

Many companies are still in the process of defining best practices for the storage and distribution of these products. Not surprisingly, therefore, failure to guarantee adequate maintenance of temperature is a common adverse observation during regulatory inspections.

This course is designed to help you avoid regulatory criticism and to assure the quality of your products from factory to patient.

What You Will Learn

• Current international regulatory requirements for controlled temperature storage and distribution of medicines
• How to put these requirements into practice in a scientifically sound and cost-effective way
• Current industry best practice

Course outline

Introduction to Current Regulatory Requirement for the Storage and Distribution of Medicines

• EU and US regulations and guidance

Cold Chain Issues

• Cold temperature storage and distribution
• Qualification and validation of cold rooms, warehouses, refrigerated transport
• Design and qualification of insulated shipping packs
• Shipping validation requirements
• Current industry best practice

Other Controlled Temperature Storage and Distribution Issues

• What is ‘room temperature’?
• Temperature mapping and monitoring expectations for storage areas and distribution systems

Controlled Temperature Storage and Distribution – What can go Wrong?

• What has gone wrong?
• How to guard against failures

Monitoring Individual Shipments

• Is it necessary?
• Who is responsible?
• How to interpret the data
• To release or not?

Venue

Manchester Marriott Victoria and Albert Hotel, Manchester, UK

The Manchester Marriott Victoria & Albert Hotel stands on the banks of the River Irwell, near the city centre but convenient for Manchester Airport (19km), the city’s Piccadilly rail station (3km) and the UK’s motorway networks.

Recently lovingly restored, this Grade II listed building bears many modern features. The hotel has its own car park and a few minutes’ walk takes you to the city’s main shopping and eating district.

Hotel Accommodation

• Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
• To take advantage of this offer, you must book via a special weblink, details of which are provided under the ‘Hotel Bookings’ section at the bottom of this page.
• This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
• If you need any help or guidance with the accommodation booking process, please contact our course administration team.
• Your account with the hotel should be settled at check-out.
• Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.

Venue Address and Contact Details

Manchester Marriott Victoria & Albert Hotel
Water Street
Manchester
M3 4JQ
England

Tel: +44 (0) 161 832 1188
Fax: +44 (0) 161 834 2484

www.marriott.co.uk

Hotel Bookings

If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following “this link”- Link to be confirmed at a later date.

This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our experts for this course are:

• 

  Dr Gary Rees
  Consultant
  BPharm, PhD, CChem, MRSC, FCQI, CQP

  • [email protected]
  • +44(0)1751 432999
• 

  Mr Darren Jones
  Consultant
  BSc (Hons)

  • [email protected]
  • +44(0)1751 432999

What you've said

“Excellent tutors, especially because they had huge experience from ‘real life’. Thanks, Stewart and Gary.”

Johnni Jaqué, Project Support A/S, Denmark

“I have benefited from this course. Very informative course.”

Akhtar Mahani, Bio Products Laboratory, UK

“I’m new in the field. This course is really a help in looking at our cold chain management system and see what still needs to be covered. It’s a lot of information that needs to sink in.”

Monique Aal, Netherlands Vaccin Instituut, The Netherlands

“Good and competent tutors, was also my experience at Good Autoclave course in Manchester.”

Nicki Brunk Lund, Project Support A/S, Denmark

“Benefited from this course: to clarify concepts about transport validation in a realistic way.”

Silvia Herrero, Laboratorios Dr Esteve SA, Spain

“Gary and Stewart presented very well and got excellent participation from all delegates. Certainly was a ‘fun’ course to be on and certainly increased my knowledge on the subject. Strongly recommend attending.”

Stephen Simpson, Perrigo UK Ltd, UK

“MHRA lecture very informative. Good to hear from auditor/regulator perspective on expectations. Whole course content very relevant.”

Daren Milsom, Clinigen Group Ltd, UK