Compli specializes in providing comprehensive compliance consulting services to help you meet the current and emerging regulatory demands and achieve compliance. Our team is dedicated to assisting you in preparing for regulatory agency audits, conducting internal audits, and advising on audit observations through remediation activities.  Additionally, Compli can support you in preparing and executing supplier audit programs to meet your unique manufacturing requirements.

These services include:

• Auditing (cGMP, Regulatory Certification, Supplier, Internal, Process)
• Standards assessments including gap analysis (EU Annex I, Data Integrity, 503B)
• Permanent Inspection readiness programs
• Assistance with Regulatory and other Competent Authority meetings (requesting, preparing for, and conducting)

Compli, a leading provider of compliance solutions, offers a comprehensive cGMP (Current Good Manufacturing Practices) training program designed to empower individuals and organizations with a robust understanding and practical application of quality standards in manufacturing.

Our cGMP training services include:

• Regulatory Compliance Education: Thorough coverage of industry-specific regulations and guidelines, ensuring participants are well-versed in the legal framework governing cGMP, with a focus on practical implementation.
• Foundational GMP Principles: In-depth exploration of fundamental concepts such as hygiene practices, facility cleanliness, documentation, and quality control procedures, providing a strong foundation for adherence to GMP standards.
• Risk Management Training: Equips participants with skills to identify, assess, and mitigate risks associated with manufacturing processes, fostering a proactive approach to quality assurance and compliance.
• Process Validation and Verification: Comprehensive guidance on methods for validating and verifying manufacturing processes, ensuring consistent and reproducible results in alignment with GMP standards.
• Documentation and Record-Keeping: Practical insights into maintaining accurate and compliant documentation, covering batch records, Standard Operating Procedures (SOPs), and essential records crucial for regulatory audits.
• Personnel Hygiene and Training: Emphasis on personal hygiene and continuous training for personnel to uphold GMP standards and foster a culture of quality.
• Cleanroom Practices: Specialized training on maintaining cleanliness and sterility in controlled environments, including gowning procedures, equipment cleaning, and environmental monitoring.
• Change Control Procedures: Guidance on proper handling of changes in processes, equipment, or personnel to prevent compromising product quality or safety, with a focus on compliance best practices.
• Supplier and Vendor Management: Expert insights into selecting, qualifying, and managing suppliers and vendors, ensuring the integrity of raw materials and components used in manufacturing processes.
• Quality Risk Management: Integration of quality risk management principles to systematically assess and address potential risks throughout the product lifecycle, enhancing overall risk management capabilities.
• Continuous Improvement Strategies: Introduction of methodologies (e.g., Six Sigma or Lean Manufacturing) to instill a mindset of continuous improvement, driving efficiency, waste reduction, and elevated quality standards.
• Mock Inspections and Audits: Practical simulations of regulatory inspections and internal audits, preparing participants for real-world scenarios and ensuring readiness for inspections.With Compli’s cGMP training services, participants benefit from a holistic and hands-on approach, gaining both theoretical knowledge and practical insights essential for maintaining compliance and achieving excellence in manufacturing practices.

Compli supports a range of life science clients from small start-up firms to large multinational pharmaceutical manufacturers. Compli can work within existing quality systems to refine and optimize to create a system from the ground up.  We utilize best practices and industry standards for quality systems to reduce cost, risk, and customize for your unique requirements. The quality support services that Compli provides will save money and reduce risk.

Services that Compli provides include:

• Quality Culture assessment, education, and deployment
• Quality Risk Management program development and implementation
• Quality Metrics program development and implementation
• Quality Investigations / CAPA Support / Deviation Handling / Root Cause Analysis
• GMP document development and assessments (SOP’s, Policies, Standards)
• Stability Management program development and implementation

Whether you have a small or large-scale project, Compli offers risk-based remediation services that can benefit your operations.

Our team of remediation professionals can organize and communicate the requirements of the remediation effort and leverage our experience to ensure success. Our professionals will identify and track every action item required for compliance remediation and escalate potential concerns to stakeholders and/or executive management for resolution. We partner with you to build your remediation plan, perform GAP assessments for all systems, and implement remediation efforts to meet your schedule and budget.

We understand the complexities associated with compliance constraints, manufacturing requirements and can support your organization to manage the remediation process to return your site to an efficient and compliant operation.