Navigating Chemistry, Manufacturing & Controls Through the Drug Development Process
Nov 4 2013 8:30AM - Nov 5 2013 4:00PM | DIA
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509
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
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
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
Hampton Inn Doylestown
1570 Easton Road
Warrington, Pennsylvania, 18976
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
Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102.
As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer 1.4 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.
This program is part of DIA’s Certificate Program and is awarded the following:
• Regulatory Affairs Certificate Program: 8 Elective Units
For more information go to www.diahome.org/certificateprograms
|Navigating Chemistry, Manufacturing & Controls
It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.
Statement of Credit:
If you would like to receive a statement of credit, you must attend the course, sign-in at the DIA registration desk each day of the course, and complete the on-line credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests onTuesday, November 19, 2013.
To view DIA’s grievance policy, please visit the CE page on the DIA website at www.diahome.org/CE
- Charitable Nonprofit/Academia Member Individual
- Member Government Individual
- Member Individual
- Charitable Nonprofit/Academia Nonmember Individual
- NonMember Government
- NonMember Standard Individual
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 print 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 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.
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.
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.