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CHALLENGES OF MANAGING API MANUFACTURING AND SUPPLY (description)

"CHALLENGES OF MANAGING API MANUFACTURING AND SUPPLY"

Category:Medical Education
Address:The De Vere Cavendish Hotel London, , United Kingdom SW1
Phone:44 1483 570099
Event dates:1/31/2006 - 1/1/2006 (This event has already taken place)
Event web site:http://www.management-forum.co.uk/html/con_semin_s
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Management Forum Ltd

Speakers/Presenters:

Topics to be Covered:

  • The Regulatory Expectations - The Cost- effective means of implementing the New Requirements for API Manufacturing and Supply The expert panel of speakers will guide you in: - How to develop a Quality Management System for an API Manufacturing Facility - How to prepare for Regulatory Inspections - How to deal with Non- Compliance Issues that may arise Historically, European Regulators have believed in the need for GMP in the API Manufacturing Process but have never enforced this expectation in anger. The US FDA, however, have always insisted that GMP applies to API Manufacturing in that they have routinely inspected and approved API Manufacturing sites involved in supplying to the US market. Directive 2001/83/EC was the first step towards applying GMP to API Manufacturing. With the launch of ICH Q7a, the industry moved towards harmonisation and acceptance of the need for GMP in Primary Manufacturing Facilities.
Contact:info@management-forum.co.uk
Organizer phone:44 1483 570099
Offering type:Conference
Specialty:Medical
Event frequency:Every Year
First Meeting:
Total events:
Est. attendance:
Target audience:Any
Other target audiences:
Host Sponsor:
Est. # of exhibitors:
Currency:Euro
Language:English
CE Credits:
Organizer URLwww.management-forum.co.uk

Description:

This two-day Training Course will attempt to clarify: - The Regulatory Expectations - The Cost- effective means of implementing the New Requirements for API Manufacturing and Supply The expert panel of speakers will guide you in: - How to develop a Quality Management System for an API Manufacturing Facility - How to prepare for Regulatory Inspections - How to deal with Non- Compliance Issues that may arise Historically, European Regulators have believed in the need for GMP in the API Manufacturing Process but have never enforced this expectation in anger. The US FDA, however, have always insisted that GMP applies to API Manufacturing in that they have routinely inspected and approved API Manufacturing sites involved in supplying to the US market. Directive 2001/83/EC was the first step towards applying GMP to API Manufacturing. With the launch of ICH Q7a, the industry moved towards harmonisation and acceptance of the need for GMP in Primary Manufacturing Facilities.

Schedule:

Registration Fee Details:

Other items that tuition includes:

Travel and hotel arrangements:

 
 
Contact Person:Barbara McManus / Leigh White
TitleHead of Business Development / Marketing Assistant
Contact Emailinfo@management-forum.co.uk
Organizer Address 148 Woodbridge Road
Organizer Address 2Guildford
Organizer CitySurrey
Organizer State/Province: (Outside US)
Organizer Zip or Postal CodeGU1 4RJ
Organizer CountryUnited Kingdom
Organizer Phone44 1483 570099
Organizer Fax44 1483 536424
Structural makeupOrganization
Event Site/VenueThe De Vere Cavendish Hotel
Event sold out?No
Multiple locations or dates?No
Statistics available for most recent event held in:NA
Average number in event attendance of:
Range:
Number in attendance of:
Range:
Target BoundariesLocal
Is Registration contact information the same as Organizer Contact above?Yes
Web Page
Can one register for your CE on your web site?Yes
E-mail registration:info@management-forum.co.uk
Can registration be made by snail (regular) mail?Yes
Online housing reservations: 
 
Do you have additional written or AV materials for sale?No
If so, are they available for non-attendees as well as those attending?NA
Is full tuition necessary to ensure registration?No
Will there be shuttle service available?NA

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