Regulatory Remediation Support

Situation

Pharmaceutical and medical device manufacturing sites, are increasingly being subjected to regulatory sanctions by a variety of regulators. Even where sanctions are not applied, there may be serious outcomes arising from regulatory inspections that have to be resolved.

The response from the company concerned is usually to bring together a team to carry out a ‘regulatory remediation’ project to identify and resolve the issues, and have any sanctions removed.

There are 2 types of situations:
  • Those companies, that understand what is required and have the expertise to resolve the issues, but are constrained by resources. Although these companies have internal understanding and expertise, they often do not have sufficient internal resource to carry out the remediation, while maintaining normal business operations and staffing other priority projects. This drives a need for recruitment or the use of contract staff, either to work on remediation activities or to ‘back-fill’ for staff temporarily transferred out of the business into the remediation project.
  • Other companies that do not have an adequate understanding of the requirements and/or do not know how to resolve the issues in a way that is acceptable to the regulators. These companies have a need to bring in the required technical expertise, either by recruitment or by use of consultants to initially identify the gaps. They also have a need for short-term contract staff either to work on remediation activities or to ‘back-fill’ for staff temporarily transferred out of the business into the remediation project.

In both cases, locating sufficient numbers of external staff with appropriate experience and skills can be both a time-consuming and costly exercise.

Verta Life Sciences has an experienced track record in the successful implementation of remediation Projects.

Remediation – How Verta Can Help

A process for Remedial, Corrective and Preventive Action (CAPA) is required by numerous codes of GMP, ISO standards and ICH Guidelines. It is a key tool for achieving continuous improvement.

Verta Life Sciences have the expertise and experience to put an effective CAPA system in place. This process will effectively identify any actual or potential quality or compliance non-conformance. It will evaluate the significance and urgency of actions, control affected material directly or indirectly, implement remedial action, identify the root cause of the problem, and propose the necessary action plan (the CAPA Plan) to prevent a recurrence. In addition it will track actions to completion, and implement documented checks to verify that the required actions have been embedded into working practices, and are effective.

Remediation Projects team deployment
  • Verta Remediation teams are led by experienced Remediation Project Managers with deep understanding of Culture Change and ways of working.
  • Change Management tools and techniques are integrated into an Implementation plan to ensure sustainable results .
  • Experienced Subject Matter Experts (SME) are deployed to support implementation.
  • Qualified junior level staff are identified to support remediation work, so the client does not have expensive SME’s performing routine tasks.
  • Client has the option to hire staff at the end of assignment.
  • Implementation plan defines milestones for key deliverables.
  • Project actively managed by Client and Verta in a collaborative manner to ensure milestones achieved within budget.
  • Client’s staff trained as part of implementation process.
  • Knowledge management and retention by Client established as key success criteria for overall remediation success.