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Microbial Data Deviation

2023 PDA Microbial Data Deviation Investigations Workshop

Oct 04 - Oct 05, 2023
Washington, DC

  • Workshop
  • The Americas

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Program Highlights

Early registration is going on now until 06 August, with up to $500 in savings!

Overview

 

Microbiological data deviations result from microbial test results that fall outside the product specification or acceptance criterion established in a drug application, drug master file, official compendia, good manufacturing practice regulations, or internally by the manufacturer. The term “microbial data deviation” is preferred to “out-of-specification” or “out-of-limit result”, as most microbiological tests, especially in a sterile product manufacturing facility, are in-process tests, not finished- product tests that must meet a regulatory-approved specification. This is an area of continued focus for regulatory authorities during inspections and document reviews. However, it is also an area of limited guidance from health authorities.
 
Attend the 2023 PDA Microbial Data Deviation Investigations Workshop to provide additional information following the 2022 MDDI Conference as well as get both a recap of the newly developed PDA Technical Report No. 88 (TR 88) Microbial Data Deviation Investigations in the Pharmaceutical Industry, as well as real world examples that can be used to develop and improve your current approaches and strategies to manage these events.

Agenda Coming Soon

Additional Information

  • Learning Objectives

    Learning Objectives

     
  • Who Should Attend
     

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Travel

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.

1000 H Street NW
Washington, DC

 

How to Get Here

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Other Options

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Directions

Registration Fees

Early Registration
Registration Type By 06 August
Member $1,595
Non-Member $1,995
Gov./Health Authority/Academic (Member Only) $795
Early Career Professional (Member Only) $1,295
Student (Member Only) $495
Regular Registration
Registration Type After 06 August
Member $2,095
Non-Member $2,495
Gov./Health Authority/Academic (Member Only) $895
Early Career Professional (Member Only) $1,395
Student (Member Only) $595

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].

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Program Inquiries
  • Brooke Lustig, CMP
    Senior Manager, Programs
    Tel: +1 (301) 656-5900 ext. 111
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Tel: +49 (0) 30 43 655 08-10
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