We help organizations maintain quality control within their processes from beginning to end, ensuring that consistent, quality products are delivered to their customers.  This includes:

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• Quality manuals – Based on FDA 6 System approach. Consistent with ISO standards, and major worldwide regulations.

• Process flow diagrams– Used to establish process-based standard operating procedures

• Record collection – Supporting forms and templates to ensure consistency

• Document design – To ensure efficiency and compliance

• Data integrity – Develop governance and processes from creation to manufacturing to the laboratory that ensure ability to reconstruct the product history and meet all aspects of ALCOA

We are highly experienced in providing comprehensive reviews of manufacturers’ adherence to regulatory guidelines, including:

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• Compliance status evaluations – For GMP, GLP, GCP, GDP (distribution  and documentation)

• Mock inspections – To prepare for inspections (FDA, MHRA, EU, etc.)

• Quality systems – To ensure systems are sufficient, integrated, and meet both the compliance and business needs of the organization

• Laboratory best practices – To ensure integrity, quality and efficiency

• Data integrity – From basic assessment to forensic analysis to ensure data is complete, consistent, enduring, and reliable

• Aseptic operations – To ensure processes, personnel, and data support product quality and aseptic operations 

Remediation is not a simple matter. It must be handled correctly and effectively, otherwise it can be cumbersome, expensive and lead to further regulatory action. We provide strategic, effective remediation initiatives to rectify issues that don’t comply with regulations. Our services include, but are not limited to:

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• Strategic advice, planning, and support – Strategic approach to remedy the problem, prevent a future issue, and regain confidence from regulatory agencies

• Inspection responses – Plan and prepare responses to regulatory inspections

• Audits – Tailored initiatives to ensure applicable system issues and causes are identified, and to verify corrective action implementation 

• Development and prioritization of system augmentation – Improvements in processes, procedures, and the integrity, accuracy, and availability of records

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Training is tailored to meet specific needs – from one-on-one to large groups – and may include topics from compliance to process flow to procedural creation. 

 

Training can be delivered via:

• On-site training

  • PowerPoint presentations

  • Supporting documentation (speaker’s notes, procedures, diagrams, etc)

  • Assessment of effectiveness

  • One-to-one mentoring

• Webinar delivery

  • PowerPoint presentations

  • Speaker’s notes (on request)

• Conference speaker

  • PowerPoint presentations

  • Speaker’s notes (on request)

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