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Parenteral Drug Association Connecting People, Science and Regulation ®

Preparing for Regulatory Inspections for the FDA and EMA

Sep 14 - Sep 15, 2017 |
Sep 15, 2017 |
Renaissance Washington, DC DowntownHotel | Washington, DC
  • Education
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Duration:  2 days
Time: 8:30 a.m. - 4:00 p.m.

As the FDA continues to perform GMP and pre-approval Inspections, the EMA has become very active in performing “foreign” GMP and pre-approval inspections at manufacturing sites in the US and other non-EU countries as well. The objective of this two-day lecture course is to assist participants in the preparation of hosting an inspection. This course will look in-depth at FDA and EMA inspection authority and practices, highlight important references to use for preparation, and provide practical, real-life examples of best practices and pitfalls to avoid. Importantly, recent changes to FDA inspection authority for pharmaceutical inspections were brought about by the FDA Safety and Innovation Act (FDASIA) legislation. This course will address those changes and the resulting changes that may be needed in company inspection management procedures and training. Concepts discussed will have relevance both for GMP and GCP inspections, with the primary focus being GMP.

Who Should Attend

This course is designed for manufacturing, regulatory and quality personnel involved in hosting and managing an EMA or FDA site inspection.

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

  • Discuss background information regarding the EU, EU governing documents, GMP rules, and the EMA
  • Identify the inspection techniques and methodologies used by the EMA inspectorate
  • Discuss and apply the EU GMP rules – Eudralex Volume 4 and Annexes and other guidance documents that impact inspections
  • Discuss strategies for hosting and managing FDA and EMA inspections
  • Compare and contrast FDA and EMA inspections
  • Create resolutions to a variety of issues that may arise during an inspection

Standard

Member

On or before July 31, 2017
$1,709

After July 31, 2017
$1,899

Nonmember

On or before July 31, 2017
$2,051

After July 31, 2017
$2,279


Government/Health Authority/Academic

Member

$1,139

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

Dave Chesney, Principal and General Manager, DL Chesney Consulting, LLC

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 #307 | ACPE #0116-0000-16-047-L04-P | 1.2 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 12 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 12 PDHs.

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