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Parenteral Drug Association Connecting People, Science and Regulation ®

Preparing for Regulatory Inspections for the FDA and EMA

Mar 15 - Mar 15, 2019 |
Mar 15, 2019 |
Marriott Marquis San Diego | San Diego, CA
  • Education
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Duration:  1 day
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 January 29, 2019
$899

After January 29, 2019
$999

Nonmember

On or Before January 29, 2019
$1,079

After January 29, 2019
$1,199


Government/Health Authority/Academic*

$599

*For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Accommodations and Dietary Requirements
If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900. SUBSTITUTION: If a substitution request is sent by February 13, 2019, no fee will be charged. After February 13, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee. REFUND: If a refund request is sent by February 13, 2019, a full refund will be given minus a $200 fee. After February 13, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

General Course Information

Please arrive at the 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.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.

Location

The course will be held at:

Marriott Marquis San Diego
333 West Harbor Drive
San Diego, CA USA 92101

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 #307-1 | ACPE #0116-0000-18-024-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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