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MedicineAndDermatology
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Bringing your projects to a higher level.
Agenda ,[object Object],[object Object],[object Object]
Cato Research Team ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Company Profile We are a full-service contract research and development organization with global resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the drug development process in order to bring new drugs, biologics, and medical devices to the people who need them.
Cato Research ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Therapeutic Expertise ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Cologne, Germany Frankfurt, Germany Riga, Latvia Graz, Austria Szeger, Hungary Zagreb, Croatia Tel-Aviv, Israel Johannesburg, South Africa San Diego, CA San Francisco, CA Montreal, Canada Boston, MA Washington, MD Durham, NC Worldwide Locations Collaborations Poland Romania Russia Ukraine India
Full Service Development Services ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Quality Assurance Best Practices in a Good Laboratory Practice Environment
First, a few words from the wise… ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Why do we need GLP? ,[object Object],[object Object],[object Object],[object Object],[object Object]
Good Laboratory Practice for Nonclinical Laboratory Studies Title 21 Code of Federal Regulations Part 58 ,[object Object],[object Object],[object Object],[object Object],[object Object]
Organization of GLPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The 10 Commandments of GLP ,[object Object],[object Object],[object Object],[object Object],[object Object]
The 10 Commandments of GLP ,[object Object],[object Object],[object Object],[object Object],[object Object]
A Few Definitions ,[object Object],[object Object],[object Object]
A Few Definitions (cont.) ,[object Object],[object Object],[object Object],[object Object],[object Object]
A Few Definitions (cont.) ,[object Object],[object Object],[object Object],[object Object]
A Few Definitions (cont.) ,[object Object],[object Object],[object Object],[object Object],[object Object]
A Few Definitions (cont.) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
A Few Definitions (cont.) ,[object Object],[object Object],[object Object],[object Object]
A Few Definitions (cont.) ,[object Object],[object Object]
§58.15 Inspection of a testing facility ,[object Object],[object Object],[object Object],[object Object]
§58.35 Quality Assurance Unit ,[object Object],[object Object],[object Object]
§58.35 Quality Assurance Unit (cont.) ,[object Object],[object Object],[object Object],[object Object]
§58.35 Quality Assurance Unit (cont.) ,[object Object],[object Object],[object Object],[object Object]
§58.35 Quality Assurance Unit (cont.) ,[object Object],[object Object],[object Object]
§58.35 Quality Assurance Unit (cont.) ,[object Object],[object Object],[object Object]
The QAU SOPs (and related) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The QAU SOPs (and related) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Good Documentation Practice ,[object Object],[object Object],[object Object],[object Object],[object Object]
Good Documentation Practice ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Good Documentation Practice ,[object Object],[object Object],[object Object],[object Object],[object Object]
Good Documentation Practice ,[object Object],[object Object],[object Object],[object Object],[object Object]
Good Documentation Practice ,[object Object],[object Object]
Raw Data Correction ,[object Object],[object Object]
Abbreviations for Reasons Ignore single line cross-off Original Entry OK STET Ignore single line cross-off Original Entry OK OE-OK Entry is illegible or has been overwritten Not Legible NL Number shown is the result of a miscalculation Miscalculation MC Data are already correctly entered elsewhere Repeated Data RD Entered word is misspelled Spelling Error SP Entry of a wrong number or incorrect word Erroneous Entry EE Definition Meaning Notation
Now, you have selected a CRO…
The due diligence starts…
Reference: Compliance Program Guidance for FDA Staff ,[object Object],[object Object],[object Object]
Bottom Line… ,[object Object],[object Object]
INSPECTIONAL General Instructions ,[object Object],[object Object]
INSPECTIONAL General Instructions (cont.) ,[object Object],[object Object],[object Object],[object Object]
INSPECTIONAL General Instructions (cont.) ,[object Object],[object Object],[object Object],[object Object],[object Object]
Areas of Expertise of the Facility ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
SOP Evaluation ,[object Object],[object Object],[object Object]
SOP Evaluation (cont.) ,[object Object],[object Object],[object Object]
SOP Evaluation (cont.) ,[object Object],[object Object],[object Object]
If the firm has computerized operations, determine… ,[object Object],[object Object],[object Object]
If the firm has computerized operations, also determine… ,[object Object],[object Object],[object Object],[object Object]
Equipment Computers ,[object Object],[object Object],[object Object],[object Object]
Equipment Computers (cont.) ,[object Object],[object Object]
Storage and Retrieval of Records ,[object Object]
Storage of Computer Records ,[object Object],[object Object]
Assess the procedures by which the study director: ,[object Object],[object Object],[object Object],[object Object]
Assess the procedures by which the study director also: ,[object Object],[object Object],[object Object]
QAU Operations ,[object Object],[object Object],[object Object],[object Object],[object Object]
QAU Operations (cont.) ,[object Object],[object Object],[object Object]
QAU Operations (cont.) ,[object Object],[object Object],[object Object],[object Object]
More scrutiny of QAU ,[object Object],[object Object],[object Object]
Facilities ,[object Object],[object Object]
Equipment (other than computers) ,[object Object],[object Object],[object Object],[object Object],[object Object]
Testing Facilities Operations ,[object Object],[object Object],[object Object]
Animal Care ,[object Object],[object Object]
Animal Care (cont.) ,[object Object],[object Object]
Test and Control Articles ,[object Object],[object Object]
Archiving ,[object Object],[object Object],[object Object]
Your audit report ,[object Object],[object Object],[object Object],[object Object]
Remembering an FDA Inspection…
A Big… ,[object Object]

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PowerPoint Presentation

  • 1. Bringing your projects to a higher level.
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  • 4. Company Profile We are a full-service contract research and development organization with global resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the drug development process in order to bring new drugs, biologics, and medical devices to the people who need them.
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  • 7. Cologne, Germany Frankfurt, Germany Riga, Latvia Graz, Austria Szeger, Hungary Zagreb, Croatia Tel-Aviv, Israel Johannesburg, South Africa San Diego, CA San Francisco, CA Montreal, Canada Boston, MA Washington, MD Durham, NC Worldwide Locations Collaborations Poland Romania Russia Ukraine India
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  • 9. Quality Assurance Best Practices in a Good Laboratory Practice Environment
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  • 37. Abbreviations for Reasons Ignore single line cross-off Original Entry OK STET Ignore single line cross-off Original Entry OK OE-OK Entry is illegible or has been overwritten Not Legible NL Number shown is the result of a miscalculation Miscalculation MC Data are already correctly entered elsewhere Repeated Data RD Entered word is misspelled Spelling Error SP Entry of a wrong number or incorrect word Erroneous Entry EE Definition Meaning Notation
  • 38. Now, you have selected a CRO…
  • 39. The due diligence starts…
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  • 69. Remembering an FDA Inspection…
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Editor's Notes

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