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U.S. Department of Health and Human Services

Drugs

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Public Workshops on Proactive Compliance, Process Validation and Contract Manufacturing Operation

Meeting information

 

On October 7-10, 2013, The FDA in co-sponsorship with the International Society for Pharmaceutical Engineering (ISPE) is conducting public workshops on Proactive Compliance, Process Validation and Contract Manufacturing. 
 
  • The workshop on Proactive Compliance will be two days, and will emphasize experiences from companies that have faced and successfully responded to complex quality and risk situations.
     
  • The workshop on Process Validation will be two days that focuses on the practical applications of the life cycle approach to process validation. The objective will be to communicate implementation strategies and new expectations in the process validation approach.
     
  • The workshop on Contract Manufacturing Operation will be one and a half day, and will include discussion about the need for established global standards and quality parameters that promote and ensure process and product integrity.

     
This website will be updated as meeting materials are developed.

 
 Date: 

 October 7-10, 2013

 

 Time:  

  8:00 a.m. to 5:00 p.m.

 

  Location:   Hyatt Regency New Brunswick 
  Two Albany Street
  New Brunswick, New Jersey 08901
 
                                                
Registration:      Participants are encouraged to register online. Onsite registration on the day of the workshop is also allowed.
 
 
The registration fee pays for the conference, meeting materials and food. The cost of registration is based on participant type, and is per conference:
 

Registration Costs
Type
On or Before 9     September 2013
After 9         September 2013
Member:
$1,545 USD
   $1,745 USD
New Member:
$1,814 USD
   $2,014 USD
Non Member:
$1,905 USD
   $2,115 USD
Government:
$500 USD
   $500 USD
Students:
$200 USD
   $200 USD
Academic/Emerging Economy Members:
$1,005 USD
   $1,135 USD

 
Special Requirements:  If you require special accommodations to participate, such as a wheelchair-accessible room or a sign language interpreter, provide a written description with your registration form. Contact ISPE Member Services by tel: +1-813-960-2105 or email ask@ispe.orgdisclaimer icon with questions. Please mark vegetarian, gluten free, or kosher, if needed, in the Special Meal Requirement box on the registration form.