Quality and Compliance Support

Global Assistance

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ICS Maven and Associates have practical experience and proficiency with respect to a wide range quality, compliance, and regulatory topics. We assist our clients in developing a solid strategy for their manufacturing, quality, and regulatory activities; by utilizing our hands-on experience to support them with shop floor GMP manufacturing challenges in commercial and clinical products.  

 

These activities include but are not limited to:

Quality Management System (QMS):    

  • Custom design QMS

  • Prepare and/or modify polices, quality standards, and procedures

  • Configure and qualify IT base system QMS (i.e. TrackWise, MasterControl, etc.)

  • Risk assessment, risk control, and risk mitigation

  • Training operators, and QA engineers

  • Modify/redesign QMS

 

Quality & Compliance Support:   

  • Management review

  • Prepare APR

  • Batch record review

  • Process design and improvement

  • Quality event management           

  • Deviation and OOS review and closure

  • CAPA management

 

Auditing:

  • Site audits (mfg., pkg., & dist.)

  • IT system audits

  • Third party suppliers qualification

  • Mock inspections

  • Due diligence support

  • Manufacturing processes review

 

QC Laboratory Support:

  • Organizational assessment  

  • ATM development and validation

  • QC equipment qualification

  • Data integrity evaluation

  • Temporary hands-on QC management and analyst support

 

Inspection Readiness:

  • Regulatory intelligence

  • Inspection preparation

  • Mock inspection

  • Inspection-team training

  • War room preparation

  • Hands-on inspection support

  • Post-inspection analysis

  • Root cause identification

  • Draft response letter preparation

  • Prepare observations remediation plan

  • Prepare CAPA

  • Hands-on remediation and CAPA execution

  • Meet with regulatory authorities

  • New site design review

 

Project Management:

  • Project planning

  • Consent decree & warning Letter management remediation strategy

  • Temporary management support

  • Third party mfg./pkg./dist.  management

  • Management training & mentoring

  • Change management

  • Quality program and organizational design

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Qualification & Validation

  • Validation master planning

  • Design qualification

  • FAT / SAT

  • Commissioning

  • F.U.E. qualification (IQ/OQ/PQ)

  • CSV

  • Data integrity

  • Process validation

  • Cleaning validation 

  • Validation program periodic review