Expert Profile
Michelle Sceppa
Principal, MSceppa Consulting
Is the Principal at MSceppa Consulting, an establish Consulting firm and is in its 12thth year in the Industry that specializes in quality systems for Pharmaceutical and Biotechnology interests. MSceppa Consulting has implemented and managed Preclinical, Clinical, and Manufacturing Quality Assurance Programs for numerous clients. As the lead auditor, MSceppa Consulting has conducted and managed more than 400 internal and external vendor audits for Drug and Biologic firms in the US and Europe. MSceppa Consulting is knowledgeable in the details of compliance with all U.S. Federal Regulations-Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) for Drugs, Biologics and Medical Devices.
Trainings by Expert
Deviations and Process Failures within a CAPA program
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
General Manufacturing
,
Quality and Safety
,
QMS, ISO 13485, CAPA
,
Laboratory
,
Life Sciences
Investigating Out of Specification Guidance (OOS) in the Laboratory
Category:
Laboratory Compliance
,
Testing and Validation
,
Laboratory
,
Life Sciences
Auditing Failure or Process Deviation Investigations
Category:
All FDA Regulated Industry
,
FDA Audit and Inspection
,
FDA Validation
,
Documentation and IT
,
Audit & Inspection-Role
,
All FDA Reg. based Audit
,
Life Sciences
cGMP 'Pitfalls' in the QC Laboratory-Preparing the QC Laboratory and Staff for an FDA Inspection
Category:
All FDA Regulated Industry
,
FDA Audit and Inspection
,
Quality and Safety
,
Audit & Inspection-Role
,
All FDA Reg. based Audit
,
Best Practices & GXPs
,
Life Sciences
Maintenance and Calibration of Equipment
Category:
Drugs and Chemicals (Pharma)
,
Testing and Validation
,
Quality and Safety
,
Laboratory
,
Life Sciences
Qualification and Audit of Suppliers and Vendors - A Risk Based Approach
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
Quality and Safety
,
Audits & Inspections
,
Supply Chain and Manufacturing
,
Supply chain & Procurement
,
Life Sciences
Auditing Analytical Laboratories for FDA Compliance
Category:
Laboratory Compliance
,
Quality and Safety
,
Audits & Inspections
,
Laboratory
,
Analytical Laboratory
,
Audit & Inspection-Role
,
Lab Audit
,
Life Sciences
