|
Computer System Validation (CSV) & Part 11 compliance
|
- Part 11 remediation
- eSignature implementations
- System testing according to GAMP V
- IQ, OQ, PQ Protocols
- Security testing
|
[BACK]
|
|
Computerized Quality
Systems
|
- Incident tracking (OOS, OOT, Deviations, Excursions, CAPA)
- Change Management SOPs
- Laboratory Automation
- LIMS, Chromatography system integration
- Instrument qualification
|
[BACK]
|
|
Computerized Manufacturing Systems
|
- Mfg Equipment Qualification
- eDMS, implementation / integration
- SCADA, MES validation
- ERP Integration
|
[BACK]
|
|
Sarbanes Oxley assessments / testing
|
- SAS70 audits
- ISACA/COBIT Assessments
- Creation of Test plans
- Execution of testing
- CISA certified staff
|
[BACK]
|
|
Internal Audits / Assessments
|
- Mock FDA inspections
- GxP compliance assessments
- internal procedure compliance
- Training reviews
|
[BACK]
|
|
Supply Chain Mgt / Supplier Audits
|
- GMP Audits of Suppliers
- Pre-purchase facility inspections
- Quality agreement assessments for CMOs
- For Cause or Deviation Audits
- Contract Laboratory Assessments
- Contract Packaging Assessments
- Distributor Audits
- Domestic and international audits
- Fiscally smart audit approaches
|
[BACK]
|
|
FDA 483 remediation
|
- FDA-483 / Warning letter, response
- Remediation guidance
- Avoidance of enforcement escalation
- Recall planning & guidance
|
[BACK]
|
|
Training
|
- Role matrix creation
- Training plans
- Creation of specific quality training materials
- Staff GxP training
- Good documentation practices
- Pre-Approval Inspection (PAI) training
|
[BACK]
|
|
Laboratory Controls
|
- Laboratory procedures
- Lab compliance assessments
- Analytical / Micro SOPs
- Integration of Lab functions with LIMS
|
[BACK]
|
|
Materials Management
|
- Material handling procedures
- Reduced testing methodologies
- FIFO processes
- ERP system integration
- Labeling compliance issues
- Stability storage programs
- Sampling methods
- QC analysis SOPs
|
[BACK]
|
|
Production Controls
|
- Product transition
- Batch Record Reviews
- Environmental controls
- Manufacturing SOPs
- Clean Room assessment
- Aseptic process evaluation
- Calibration and Maintenance processes
|
[BACK]
|
|
Document Controls
|
- Compliant procedure formats
- eSignature assessment / implementation
- Documentation storage & archiving guidance
- Document “Road Maps” to successful PAI
- Forms management
- eDMS implementation
|
[BACK]
|
|
Product Complaint Handling
|
- Complaint investigation procedures
- Medwatch reporting
- MDR Reporting
- Complaint form creation
|
[BACK]
|
|
Incident Management / CAPA
|
- Root Cause Analysis guidance
- Incident identification & Mgt
- OOS, OOT, OOE procedures
- CAPA closed loop processes
|
[BACK]
|
