Establishing and Implementing an Effective GMP Auditing Program

Bethesda, MD
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The role of the GMP auditor can be one of the most challenging ones in the pharmaceutical, biopharmaceutical and medical device industries. Performing an independent assessment of operations, identifying areas of potential concern, and ensuring appropriate and effective corrective actions are taken is critical to ensuring firms maintain a solid compliance posture and that management is aware of any potential compliance concerns.

This training course is designed to give participants an understanding of the value in identifying the perils and pitfalls in establishing and running an effective GMP audit program and ways to overcome them. The unique challenges associated with supply chain auditing will also be addressed. The training course will be interactive, using a combination of lecture, case studies and small group discussions. Participants will develop an audit plan and supporting documentation during the session. Attendees will prepare an audit report using examples of actual audit findings provided by the trainer.

At the conclusion of the training course, participants will have a better understanding and awareness of why an audit program is necessary, how it should be constructed, operated and maintained, as well as an appreciation for the most effective ways to communicate and follow up on audit findings.

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

PDA Quality Assurance Training Courses

  1. Identify common perceptions and misperceptions associated with GMP auditing and how to address them
  2. Develop effective audit plans and prepare and use documentation to support the audit process
  3. Identify different types of audits and determine where and when to use them
  4. Prepare and deliver effective audit reports to appropriate levels of management and conduct effective follow up
  5. Examine the unique challenges associated with supply chain auditing and develop strategies to address them

Standard Registration

Member Price


GovernmentMember Only


Health AuthorityMember Only


AcademicMember Only




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].

Day 1

Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Agenda is subject to change.

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.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD , USA

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

DoubleTree by Hilton Hotel Bethesda
8120 Wisconsin Avenue
Bethesda, MD 20814

Please visit the hotel’s website for more information.

How to Get Here
By Air

The Washington/Bethesda area is serviced by the following airports: 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 $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.