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Navigating Chemistry, Manufacturing & Controls Through the Drug Development Process

Nov 4 2013 8:30AM - Nov 5 2013 3:30PM | DIA 800 Enterprise Rd Ste 200, Horsham, PA 19044-3509 USA

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Overview 

The regulations surrounding Chemistry, Manufacturing, and Controls (CMC) can often seem daunting and challenging.  However, with the proper training and knowing where to look amongst the FDA regulations and other important resources, you can become an informed and knowledgeable regulator that can tackle CMC issues.   This course will allow you to arm yourself with the tools to write and/or assemble CMC sections of regulatory submissions, prepare for and orchestrate CMC meetings with the FDA, and provide a clear understanding on how to avoid non-compliance.

 

What You Will Learn 

  • The CMC components of INDs and NDAs/CTDs
  • Tools to write or assemble CMC sections of Regulatory submissions
  • How to prepare for CMC meetings with FDA
  • FDA 483s and how to avoid them
  • Navigation through the myriad guidelines and guidance documents

Who Should Attend 

  • Regulatory Affairs professionals
  • Quality Assurance and compliance personnel
  • CMC and Manufacturing personnel

Learning Objectives 

At the conclusion of this course, participants should be able to:

  • Recognize FDAs regulatory expectations and the regulatory framework
  • Outline the CMC sections of INDs/NDAs/CTDs/DMFs
  • Assemble the CMC sections of INDs and NDAs/CTDs
  • Address regulatory documents affected by CMC
  • Design labels required for INDs and NDAs
  • Explain the FDA inspection process and how to avoid or minimize 483s
  • Construct a stability protocol

Special Offers 

Group Discounts Available! Register 3 and Get the 4th FREE!

Hotel & Travel 

Training Course Location
DIA Worldwide Headquarters
800 Enterprise Road, Suite 101
Horsham, PA 19044

Hotel Information
Homewood Suites
2650 Kelly Road
Warrington, PA 18976
Phone +1-215-343-1300
Fax +215-343-1335

A limited number of rooms are available at the reduced rate shown below (DIA is guaranteed until October 20, 2013, or until room block is filled). Attendees should make airline and room reservations as soon as possible.
When making reservations, mention the DIA training course.

Standard Room Rate 
$119
Click here for more hotel information

Contact Information 

Registration Questions
Marilyn Ginsberg, Customer Service Associate
Phone +1.215.442.6135
Fax +1.215.442.6199
Marilyn.Ginsberg@diahome.org

Agenda and Event Details
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199
Susan.Berkelbach@diahome.org

Faculty 

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Registration Fees 

Member

Charitable Nonprofit/Academia Member Individual
$810.00
Member Government Individual
$810.00
Member Individual
$1375.00
Member Individual (As of 10/15/2013)
$1475.00

Non-Member

Charitable Nonprofit/Academia Nonmember Individual
$1035.00
NonMember Government
$1035.00
NonMember Standard Individual
$1700.00
Group Discounts

Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already discounted fees for government or charitable nonprofit/academia.

To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.



Cancellations
Cancellations must be received two weeks prior to the first day of the course.  A $200 administrative charge will be deducted from the original registration fee.  Cancellations must be in writing and received in the DIA office according to the timeline above.  There will be no refund if cancellation is received with two weeks from the first day of the course.  Registrants are responsible for cancelling their own hotel and travel reservations.  Registrants who do not cancel prior to the course and do not attend will be responsible for the full registration fee.  DIA reserves the right to alter the venue, if necessary.  If an event is cancelled, DIA is not responsible for airfare, hotel or other costs incurred by registrants.

Transfers
You may transfer your registration to a colleague at any time but membership is not transferable.  Please notify the DIA North American office of such transfers in writing as soon as possible.  Substitute registrants will be responsible for the nonmember fee, if applicable.

Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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