PDA 211 Quality and Compliance Management for Virtual Companies

Bethesda, MD
106 days left to save!
Ask a Question

Many biotech companies and some pharma companies today are small, “virtual” organizations that outsource most GxP-governed activities such as clinical trials, manufacturing, packaging, laboratory testing, and drug safety monitoring. Such companies often lack in-house knowledge of GCP, GLP and GMP requirements, or have such knowledge vested in very few people. The prospect of an FDA inspection can be a daunting one, as can ensuring that your vendors will pass FDA scrutiny.

This training course will help you understand what you need to have in place, what the high-risk areas are, and how best to manage those risks as you grow and bring activities in-house. This training course explains the GMP, GCP and GLP responsibilities of virtual companies or others who predominately outsource GxP-governed activities.

Upon completion of this training course, the attendee will be able to:

  1. Explain GMP and GCP requirements for virtual companies
  2. Decide which elements of your quality system should be managed in-house and how

For more options and/or related training courses, please visit the following page(s):

Early Registration

Register by 09 September 2024

Member Price

$1,349

GovernmentMember Only

$1,049

Health AuthorityMember Only

$1,049

AcademicMember Only

$1,049

Non-Member

$1,619

Standard Registration

Register after 09 September 2024

Member Price

$1,499

GovernmentMember Only

$1,049

Health AuthorityMember Only

$1,049

AcademicMember Only

$1,049

Non-Member

$1,799

See Qualifying Criteria for Member Types.

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 [email protected].

Agenda is subject to change.

Featured Trainers

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.

Accommodations

The following hotels are located near the training course location:

Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814

Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814

Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD 20814

How to Get Here
By Air The following airports are near the training course location: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).
By Car There is a parking garage located at the training course location. The fee is $13/day. Please take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.
By Other Options Metro: Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location. Amtrak: Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.