Proactive: Plan and Prepare for Premarket Production Development

Plan and prepare for quality and compliance to drive customer satisfaction and business success with our FDA regulatory consulting firm—QualityHub.

Premarket Product Development

1. Introduction

Does your organization maintain a Plan-Do-Check attitude? Quality and compliance don’t just happen; they come with management commitment, careful planning, execution and monitoring to ensure effectiveness. Let’s consider how a Plan-Do-Check strategy can help your organization meet internal and external customer needs.

Establishing plans for product design, risk management, quality control and validation of production lines are all expected in life science industries. These plans are often reviewed as part of regulatory inspections and audits. Plans provide a means for communicating intentions, responsibilities, resource allocation and methods to internal and external customers (including the FDA).

QualityHub’s subject matter experts and regulatory professionals can help your organization develop strategic plans for regulatory approval and commercialization of a new product. This includes guiding our clients through the right regulatory pathway, initiating early meetings with FDA to improve the likelihood of successful approval, and determining tasks necessary to support design transfer followed by commercial readiness (i.e. product realization).

We can assist in developing, organizing, and/or reviewing premarket submission content. Our former FDA associates can anticipate any questions reviewers may have, so these can be minimized in the review cycle.

Developing design plans concurrent with risk management plans are required by medical device regulations and ISO 14971, respectively. These plans are often complex and subject to regulatory inspection, so content and clarity are important. Planning for medical device development and risk management can help ensure tasks and deliverables expected by regulators (and necessary for the development of safe and effective products) are identified and agreed to by stakeholders.


2. Plan for Success

Quality control plans will ensure products consistently meet approved specifications, and quality plans typically provide oversight and strategy for continuous improvement projects such as quality system improvement or manufacturing process improvement and optimization. These types of plans provide an important means for demonstrating a commitment to quality and alignment with FDA and ISO expectations while providing a means for communication of objectives, deliverables and responsibilities to internal team members. While planning for development, risk, quality, etc., companies should also plan for compliance. One aspect of this is having an FDA inspection readiness plan that defines tasks that will help prepare the company and its employees for an FDA inspection. These plans establish goals for:
  • Mock inspections
  • Practice interviews with key staff
  • Improved logistics for managing the inspection process
QualityHub’s former FDA associates have proven success in preparing medical device, pharmaceutical and biologic companies, plus their contract manufacturers, for inspections by elevating the confidence of the inspection management team and improving inspection outcomes.

3. Implement the Plan

Once plans have been cross-functionally approved, the appropriate personnel should execute the plan. This includes providing routine updates to project managers, steering committees, and/or executive leadership teams on progress against plan.

In cases where additional resources or expertise is needed, QualityHub can provide temporary professional staff to either backfill positions for employees diverted to strategic projects, or can provide resources to execute and/or review planned deliverables. QualityHub also has experienced project managers who can help monitor project plan milestones, track deliverables, and ensure communication between stakeholders.

It is important to ensure objective evidence is developed to demonstrate compliance with approved plans, whether objective evidence applies to quality projects, design control, risk management or process validation. Objective evidence includes not just the tangible deliverables of the plan, but evidence of meetings, communication and periodic reviews required by the plan.

Let us help your team implement plans correctly the first time using well-defined plans which are tailored to your organization’s business goals.


4. Check to Verify

Successful completion of quality and compliance projects requires verifying effectiveness. This means verifying the execution of projects against approved plans and most importantly, assuring that the deliverables meet regulatory requirements. The deliverables could be, for example, new or modified quality system processes, a new device with a design history file and risk management file or a protocol and report for a validated manufacturing process.

Deliverables may be reviewed as part of a targeted verification audit or as part of a regularly scheduled internal audit. Internal audits always require the use of an independent auditor, someone not responsible for the area or subject being audited.

When additional resources, expertise or an independent assessment is needed, QualityHub can fill that need with a pool of professional compliance auditors with specialized expertise in a number of product types, technologies and processes. Many of our audit team members are former FDA investigators who are not only able to provide comprehensive audits but also provide mentorship and training to the organization’s internal audit team to improve their audit skills and techniques.

Many companies have chosen to outsource their internal or supplier audits to QualityHub because of the skills and independence we bring to the audit. Outsourcing can be more cost-effective than hiring internal FTEs.

Plan-Do-Check knowing QualityHub is ready to assist your company’s initiatives to establish quality and compliance as a means of ensuring customer satisfaction and business success.

Does your organization have a Plan-Do-Check attitude? Let's talk.