PDA 620 Technical Report No. 88 Microbial Data Deviation Investigations in the Pharmaceutical Industry

Bethesda, MD
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Microbial data deviation investigations (MDDIs) are notoriously difficult to perform for even the most experienced investigators. MDDIs often focus on an event that has occurred several days or weeks in the past and direct evidence for the root cause is usually rare. As a result, investigators often have only circumstantial evidence and historical data to rely on when attempting to piece together a comprehensive analysis of the root cause.

This practical, interactive training course will utilize real-life scenarios and examples to guide attendees through the investigative process. They will begin with how to provide timely and appropriate notification when a MDDI occurs followed by how to perform effective laboratory and manufacturing investigations, utilize techniques for robust root cause analyses and batch impact assessments, and determine and implement appropriate and effective Corrective and Preventative Action (CAPA).

Attendees will also learn important pitfalls to avoid that can prevent determination of the root cause and how to document an investigation properly and objectively without bias. Attendees will leave with a better understanding of the unique aspects of MDDIs and an improved skill set that will allow them to better address MDDIs, thus increasing their investigational success rate.

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

  • Understand the unique aspects of Microbial Data Deviation Investigations (MDDIs) and how to work through them
  • Establish and lead a comprehensive investigation team
  • Know how to gain support from key players and stakeholders when needed
  • Conduct thorough laboratory investigations that will facilitate the subsequent manufacturing investigations
  • Justify and utilize common tools for root cause analysis
  • Execute robust root cause analysis and establish appropriate, effective Corrective and Preventative Action (CAPA)
  • Recognize pitfalls that can derail an investigation and prevent discovery of the definitive root cause
  • Perform comprehensive batch impact analysis
  • Scientifically support decisions and conclusions without bias
  • Thoroughly and objectively document an investigation
  • Effectively frame and present the investigation to an audience

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

Standard Registration

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.

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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.