January 30, 2018
By Patricia Santos-Serrao, Director of Product Strategy, MasterControl
Challenge / Obstacle: You are new to the organization and are developing the regulatory plans and strategies.
Tip: Realize the situation you have inherited. Before you can successfully reach your regulatory milestones, you must become familiar with the products, processes and people you will be working with. Understanding these dependencies is a prerequisite to making any progress.
Identify Key Stakeholders
A good place to start is to identify the key stakeholders and decision makers in each department. This exercise will show you how close what is on paper is aligned to what is done in practice. Finding out “who is who” in each department will come with an explanation of their activities… pay attention to the overall scheme and coordination that takes and the various approaches, tactics, and means each department uses to accomplish their tasks. You will need this understanding to be effective as a regulatory leader.
Once you’ve identified the key stakeholders and decision makers in each department, take the time to meet them and develop a good rapport. Understand and respect each department’s chain of authority and how they are connected to each other – your success as a regulatory leader will depend on your ability understand and utilize these structures that are in place.
Perform a Regulatory Due Diligence Audit
Knowledge is power. Before you embark on the adventures ahead, you must know what compliance gaps or performance obstacles may currently exist. An accurate assessment of the bottom line of your new company’s compliance status will need to include answers to the following questions:
- Are you working with misbranded products? You may have inherited a product roster that has been significantly modified since its regulatory filing.
- Has the company received any compliance actions from regulatory authorities? Has there been a frequent request for information or clarification from a particular business area (clinical, engineering, manufacturing, etc.) that warrants investigation and/or some proactive action to ensure transparency? Review the audit and inspection results from at least the past five years, and check the compliance status on each audit observation. Be sure to dig deeper into any repeat observations.
- Identify the individuals who approve controlled documents from each functional area. Make an assessment of their level of expertise in the subject matter they are appointed to be the decision maker on. Do they perform thorough reviews and catch the issues they should be capable of preventing? Or, do they approve documents so quickly that the necessary time was clearly not taken.
- Perform a very high-level review of product labeling and determine if the information (performance statements, claims, specifications, etc.) can easily and methodically be traced to supporting objective evidence. Do you have to spend substantial time checking to see if statements are false or misleading? If the information is clearly traceable to supporting objective evidence, can you also routinely find it in the product’s most recent regulatory submission?
- What departments or functions would you score the lowest on having adequate resources? These are areas where you should expect to find inadequate documentation, missed or ignored requirements, or a backlog of unresolved issues. In the world of compliance, your company is only as compliant as its weakest link… in this case, the area that has the most opportunity for noncompliance.
Create Appropriate Regulatory Presence within the Organization
Where, when and how regulatory fits into each stage of the product development lifecycle will give you insight on the overall compliance standing of your company. When regulatory has early involvement in the processes that determine the safety and effectiveness of the product, compliance gaps are less likely. Regulatory presence throughout the organization also indicates greater potential for the capacity and effectiveness of your regulatory team and the regulatory plans and strategies you will be putting into place.
If you know anything about risk management, you know that the first choice method for risk mitigation is to design-out the risk (i.e. mitigate the risk by implementing design enhancements to the product). It’s the same concept for compliance management… the first choice method in reducing the probability of compliance issues for a company is to design-out any noncompliance and design-in compliance. This is accomplished by “designing” regulatory presence into each stage of the product development lifecycle. Best practices for the presence of regulatory affairs within pharmaceutical and medical device organizations must include all the functional areas that have the potential to create compliance issues.
The appropriate level of regulatory presence can be illustrated in the following example:
Where: Design control processes
When: At the beginning of the design planning stage. Preventing compliance issues always wins over correcting compliance issues.
- Contributor to the design plan – assessment of the regulatory conditions and their impact on the resources needed for design and development, determination of significant portions of the project timeline, and overall feasibility.
- Contributor to the design input – identification of all applicable regulatory requirements for the product. When regulatory involvement is present in the development of the design inputs, the result is development of a product that is intrinsically compliant. When regulatory involvement is omitted from the development of the design inputs, the result is often development of a product that is intrinsically non-compliant. The development process is then extended so that the non-compliant design aspects can be mitigated into being compliant through product modifications or other methods (testing, etc.).
- Reviewer of the design output and member of the design review committee – acting as a gatekeeper to ensure the regulatory requirements of the design input are present in the design output.
- Reviewer of the design verification and validation – regulatory expertise is necessary in the creation and review of test protocols and reports because there are many specific regulatory requirements that need to be addressed within these technical documents. The verification and validation represents a significant portion of the documentation submitted to regulatory authorities in the pursuit of product approval. Regulatory personnel will review the test protocols and reports with the same subject matter expertise that the regulatory authorities will be using.
- Contributor and reviewer for the product launch and commercialization documentation – regulatory personnel will need to identify of the regulatory requirements for manufacturing and create the required post-market product regulatory documentation.