Investigating Microbial Data Deviations
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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.
Time: 8:30 a.m. - 4:00 p.m.
Agenda
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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
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Venue Details and Accommodations
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.
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli RdNorth Bethesda, MD United States
Jeanne Moldenhauer, Excellent Pharma Consulting
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Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
Continuing Education for Pharmacists
PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:
PDA #441 | ACPE #0116-0000-14-073-L04-P | 0.6 CEUs
Type of Activity: Knowledge
Continuing Education for Professional Engineers
New Jersey
PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.
The credit value of this course is 6 CPC credits.
North Carolina
PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.
The credit value of this course is 6 PDHs.
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