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Auditing and Validation Services for FDA Regulated Industry

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P Aud

Providing GXP Auditing - Remediation - Validation - Training

Conducting Clinical Research in a Global Regulatory Environment
3 Day on-site
GCP Boot Camp Training Seminar - All Inclusive!

Training - Continental US - $5,995.00

Training - International - $7,995.00

3 day intense Boot Camp Includes:

  • Travel, Hotel & Expenses
  • Binders for 10 persons*
  • Certificates for 10 persons*

* Additional Attendees $25.00 each

Enhance your training experiance by having an optional Pre-Training GCP Audit conducted!

Day 1 Topics Day 2 Topics Day 3 Topics
-Training Objectives and Introductions
-Drug Development Cycle
-Regulatory Environment
-Blinding and Proper Management of Blinds
-Adverse Events/Serious Adverse Events
-Role of Committees in Research
-Clinical Plan and Gearing up for the Study
- Monitoring and Associated Monitoring Plan
Protocol Violations/Deviations/Exceptions
Case Studies with Protocol Violations/Deviations/ Exceptions
21 CFR Part 11 - Electronic Systems Basics

21 CFR Part 11 - Electronic Systems (Cont.)
Source Documentation
Pre-study visit - case studies
Morning Break
Monitoring Visits – case studies
Close-out Visits/Record Retention – case studies
Informed Consents – A process or a document?
Managing Vendors/CROs
Investigational Product Accountability, Reconciliation and Handling
Fraud and Misconduct
Afternoon Break
Fraud and Misconduct – Case studies
Regulatory Inspections
Conclusion of training

21 CFR Part 11 - Electronic Systems (Cont.) - GLP
21 CFR Part 58 Good Laboratory Practice for the US Market
21 CFR Part 58 Good Laboratory Practice for the US Market
21 CFR Part 820 (Predicate QA Ruling)
Good Validation Practice – Systems, Hardware and Software
Good Validation Practice – Methods, Procedures and Processes
Laboratory Information Management Systems/Software/Packages
Afternoon Break
ISO 17025 / OECD Series 1 - General Principals of GLP
Auditing GLPs including Train the Trainers

All training sessions are flexible for modifying the curriculum to include additional focus on;

 Process mapping as an auditing tool
 IRB/IEC Audit and Inspection
 Handling a FDA inspection
 Audit of CTR (clinical trial report)
 Qualification of a CRO/external vendor
 Drug development Cycle
 Adverse events/Serious adverse events
 Role of committees in research
 Monitoring and associated monitoring plan
 Clinical plan and gearing up for study
 Source documentation
 IP accountability, reconciliation and handling




GMP Publications

GXP News for the Regulated Industry Whats new with the FDAGXP Academy
GXP Recruiters - Recruiters for the BioPharmaceutical Industry

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Auditing - Full Service Auditing Services