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Pharma & Biotech GMP Consulting | Altabrisa Group

Expert GMP compliance consulting for pharma, biotech, cell & gene therapy, and vaccines. Reduce risk, improve systems, and meet FDA expectations.

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  • About Us
    • Altabrisa Approach
    •  AdaptiStrat™ Consulting Framework
    • Debarment Certification Statement
  • Industries
    • Pharmaceutical Consulting
    • Biotech Consulting
    • Cell & Gene Therapy Consulting
    • Vaccine Manufacturing Consulting
    • CDMO Compliance & Oversight Consulting
    • GMP Laboratory Consulting
  • Consulting
    • Quality Assurance
    • Quality Control
    • Training, Coaching, and Mentoring
    • Data Integrity/Data Governance
    • Quality Audits
    • CAPA Management
    • cGMP Compliance
    • Change Control Management
    • Deviation Management
    • Quality Systems
    • Batch Record Review
    • Document Management
    • Person in Plant (PIP)
    • FDA Readiness
    • Lean QC Laboratory
    • Quality Oversight
    • Retrospective Deviation
    • CDMO/CMO Laboratories
    • GMP Laboratory Consulting
    • FDA Warning
    • 483 Compliance
    • Warning Letter Consulting
  • Insights
  • Contact Us

Category: Deviation Management

3 Essential Best Practices for Aseptic Processing Deviation Investigations

aseptic processing deviation guidelines

Critical aseptic processing investigations require thorough root cause analysis, cross-functional teams, and data-driven CAPAs—but how effectively are you implementing them?

7 Essential Strategies for Manufacturing Equipment Deviation Prevention

manufacturing equipment deviation prevention

Mitigate costly manufacturing disruptions with these seven proven strategies that equipment managers can’t afford to overlook.

FDA Cgmp Deviation Reporting Requirements: What Are They?

fda cgmp deviation guidelines

Track FDA CGMP deviation reporting deadlines or face severe penalties—what manufacturers don’t know could shut down their operations.

Key Pharmaceutical Laboratory Deviation Investigation Procedures

pharmaceutical deviation investigation procedures

Comprehensive deviation inquiry protocols safeguard pharmaceutical integrity, but one misstep can derail your entire quality system.

Key Roles in a Pharmaceutical Deviation Investigation Team

pharmaceutical investigation team roles

Key roles in pharmaceutical deviation investigations create a powerful team that ensures safety, but who leads when everything goes wrong?

Navigating the Pharmaceutical Manufacturing Deviation Investigation Timeline

pharmaceutical deviation investigation timeline

Swift pharmaceutical deviation management requires specific timelines for containment, investigation, and resolution—are you meeting these critical compliance deadlines?

Responsibility for Deviations in Pharmaceutical Contract Manufacturing

contract manufacturing accountability issues

Shared quality oversight becomes critical when pharmaceutical deviations occur, but who truly bears the regulatory responsibility?

Step-by-Step Guide for CAPA Effectiveness Verification in Pharmaceutical Deviations

capa effectiveness verification process

Unveiling proper CAPA verification ensures pharmaceutical deviations truly disappear, but most companies overlook this critical final step.

Step-by-Step Guide for Electronic Deviation Management System Implementation

electronic deviation management implementation guide

Unlock the potential of streamlined quality control with our proven implementation roadmap—but are you prepared for the challenges ahead?

Using the FDA Warning Letter Deviation Response Template Effectively

fda warning letter response

FDA warning letter response templates require strategic implementation to satisfy regulators, but many companies overlook this critical element.

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Expert GMP compliance consulting for pharma, biotech, cell & gene therapy, and vaccines. Reduce risk, improve systems, and meet FDA expectations.

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