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:

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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