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Parenteral Drug Association Connecting People, Science and Regulation ®

CMC Regulatory Requirements in Drug Applications

Sep 14 - Sep 14, 2017 |
Sep 14, 2017 |
Renaissance Washington, DC Downtown Hotel | Washington, DC
  • Education
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Duration:  1 day
Time: 8:30 a.m. - 4:00 p.m.

This course provides a basic understanding of chemistry, manufacturing and control (CMC) requirements in drug applications. It will help prepare those in regulatory affairs to better address the key points required in the CMC sections of drug applications. Topics to be covered include CMC in investigational new drug (INDs) applications, new drug applications (NDAs), abbreviated new drug applications (ANDAs), drug master files, and post-approval change supplements. Manufacturing GMP compliance and an introduction to biological licensed application (BLA) will also be briefly discussed.

Who Should Attend

Personnel in CMC Regulatory Affairs, QA and QC, and chemical research and development will benefit from this course.

Upon completion of this course, you will be able to:

  • Identify different drug applications/supplements
  • Explain CMC requirements for different drug applications or supplements
  • Discuss key points in preparation of CMC section for different drug applications

Standard

Member

On or before July 31, 2017
$1,169

After July 31, 2017
$1,299

Nonmember

On or before July 31, 2017
$1,403

After July 31, 2017
$1,559


Government/Health Authority/Academic

Member

$779

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by August 15, 2017, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

Class Schedule

All lecture courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.

Please arrive at your course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided from 12:00 - 1:00 p.m. Snacks will be provided during the morning break from 10:00 - 10:15 a.m. and the afternoon break from 2:30 - 2:45 p.m.

Location

The course will be held at:

Renaissance Washington D.C. Hotel
999 9th St NW
Washington, D.C. 20001 USA
Phone: +1 (202) 898-9000

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: ko@pda.org

Zi-Qiang Gu, PhD, Pharmaceutical Consultant, Former FDA CMC reviewer and GMP Compliance Officer

Continuing Education for Pharmacists

ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #253 | ACPE #0116-0000-16-004-L04-P | 0.6 CEUs
Type of Activity: Knowledge

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 6 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 6 PDHs.

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