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Investigating Microbial Data Deviations

Oct 18, 2018
North Bethesda, MD

This course will provide practical insights into both the regulatory and scientific considerations which must be taken when investigating microbiological data deviations.

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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

Overview

Out of Specification (OOS) test results are sometimes encountered during analytical testing of drug substances and products. Existing FDA guidance addresses the investigation of OOS test results, but is silent on the subject of data deviations encountered in microbiological testing. However, these are often encountered in pharmaceutical quality control laboratories. This course will provide a practical approach which may be applied globally for the investigation of microbiological data deviations. The roles of manufacturing, the testing laboratory and Quality Assurance will be considered, and fundamental elements to be addressed in writing reports summarizing those investigations will be covered. Flowcharts, checklists and process flow diagrams will be utilized to illustrate the concepts presented. This course is based on an upcoming PDA Technical Report addressing the same subject.

This course will provide practical insights into both the regulatory and scientific elements which must be taken into consideration when investigating microbiological data deviations. Participants will come away with an understanding not only of what the considerations are, but a practical approach of how to design and conduct investigations into microbiological test data which appears inconsistent with expectations and trends.

Who Should Attend

This course will be of value to quality control staff who conduct and assess the results of microbiological testing. It will also be of benefit for those quality control and quality assurance staff who conduct investigations into microbiological data deviations and write and approve reports of those investigations. Analysts, laboratory supervisors and managers and quality assurance staff will all benefit from attendance at this course.

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Agenda

  • Upon completion of this course, you will be able to:

    • Identify microbiological test results which deviate from anticipated results and trends
    • Explain the responsibilities of laboratory, manufacturing and quality assurance staff in preparing for, conducting, reviewing and documenting investigations into microbiological data deviations
    • Describe the essential elements of reports of investigations into microbiological data deviations
    • Discuss the benefits of flowcharts, checklists and process flow diagrams as they apply to the investigation process
    • Apply the concepts learned in situations involving microbiological data deviations when necessary

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

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Travel

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Bethesda North Marriott Hotel & Conference Center

5701 Marinelli Rd
North Bethesda, MD

How to Get Here

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Registration Fees

Regular Price

Standard

Member

On or before September 3, 2018
$1,192

After September 3, 2018
$1,325

Nonmember

On or before September 3, 2018
$1,431

After September 3, 2018
$1,590

Government/Health Authority/Academic

Member

$795

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by September 18, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.

Location

The course will be held at:

Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Rd
North Bethesda, MD 20852 USA

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: [email protected]

* For this member type or discount, online registration is not available, please contact [email protected].

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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