Preparing for Regulatory Inspections for the FDA and EMA
Become a Sponsor and/or Exhibitor
Registration Options
Individual Registration
Group Registration
This training course will help to assist participants in the preparation of hosting an inspection. During this training course, you will learn about the 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 training 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.
- 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
Agenda
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Training courses run from 8:30 to 16:00 each day. An agenda will be provided on the first day of the training course.
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Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Marriott Marquis San Diego
333 West Harbor DriveSan Diego, CA USA
Marriott Marquis San Diego
333 West Harbor Drive
San Diego, CA USA 92101
Tel: +1 (619)-234-1500
Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!
A block of rooms have been reserved for meeting participants at the Marriott Marquis San Diego. The rate is $289* for single or double occupancy. *Guestroom rates are subject to State and Local taxes, 10.5% occupancy tax, 2% San Diego Tourism Marketing District tax and $0.77 Commerce Fee per room per night. Tax rates are subject to change without notice. Reservations must be secured by Monday, February 11, 2019. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.
To make reservations, individuals may click on the reservation link above or call the Marriott Marquis San Diego at +1 (888) 236-2427. Please make sure to tell the reservationist that you are with the PDA group attending the 2019 PDA Annual Meeting to receive the PDA group rate.
Individual Cancellation
Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days prior to the date of arrival to avoid cancellation fees.
Read about the amenities offered at the Marriott Marquis San Diego.
How to Get Here
Registration
Pricing Options
Standard Registration
Member Price
$999 $599GovernmentMember Only
$599
Health AuthorityMember Only
$599
AcademicMember Only
$599
Non-Member
$1,199 $599
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to registration@pda.org.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
Become a Sponsor and/or Exhibitor
Amplify Your Presence and Reach Your Customers!
Become a Sponsor
Elevate your brand and maximize your exposure by becoming a sponsor at the Preparing for Regulatory Inspections for the FDA and EMA! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.
Request InformationBecome an Exhibitor
Boost your brand and visibility by becoming an exhibitor at the Preparing for Regulatory Inspections for the FDA and EMA! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.
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