Remediation of Quality and Compliance “Issues” The Good, the “Meh”, and the Ugly

Teresa Gorecki

VP and Practice Lead

Compliance Architects

Let me set the stage…

The Opening Scene ??

The FDA has just closed out what began as a routine, general inspection.? The FDA Form 482 was served by the FDA Investigator(s) and the inspection commenced.? The lead FDA Investigator stated the purpose of the inspection and estimated that the inspection would take approximately 4 to 5 days max.? The site team is assembled, the back room and front room are ready, and the inspection begins.

Fast forward to the Closing of the First Scene

The FDA Investigator(s) arrive for the final day of the inspection and initiate the final steps they need to complete prior to issuing the FDA Form 483 to the “site leader”.

The Form 483 is presented and reviewed during the close-out meeting with the FDA and site leadership team.? As you read the FDA Form 483, anxiety and stress build and you realize the FDA Form 483 may not be the end of the story unfolding on this stage.? There may be a sequel to this story that will occur on a bigger stage with more critics present and unfavorable “reviews” published broadly online in an FDA Warning Letter, Product Recalls, suspended production resulting in shortages, and etc.

Flashback to the Inspection

It was a long and stressful inspection with 7 to 9 days of inspection.? There were a number of “issues” discussed.? Big issues.? The site was prepared for the inspection and had “story boards” prepared to better explain the “issues”.? The subject matter experts (SMEs) were prepped and had rehearsed weeks to months prior to the inspection and had further rehearsed during the inspection prior to entering the front room of the inspection.? The “issues” reviewed with FDA included a veritable potpourri of Deviations/Nonconformances, CAPAs, Change Controls for major changes, Serious Complaints, and other documented outputs of the Quality System.? FDA verbally stated they have concerns and communicated potential Observations they intend to document on a Form 483 throughout the inspection.

Back to the Closing of the First Scene

The FDA Investigators leave the site, and you gather the site leadership team to discuss the FDA Form 483 Observations and initiate the process to develop the FDA 483 Response which is due in 15 business days.? When the meeting with the site leadership team is over, you return to your office with the site leader and call the executives/senior leaders you both report to.? As you initiate the call, you send an email with the FDA Form 483 attached.

Now What?

There are many nuances and details that exist within this general scene, but one thing is certain, the site needs outside experts to support the preparation of the FDA 483 Response.? Expert support will also be needed to plan and execute the commitments made in the FDA 483 Response.

How do you Select the Experts Needed?

This is where The Good, the “Meh”, and the Ugly enter stage left.? Your experience with Quality and Compliance consultancies may be good, may be “meh”, or may be downright ugly and unpleasant.? How do you select the right Quality and Compliance experts to enable you to achieve the best possible outcome with FDA?

You need to know what you need and how to interview and select the right Quality and Compliance Consultants.

There are two distinct phases of any remediation project:

1.???? Developing the right FDA 483 Response.

2.???? Planning and executing the FDA 483 Response Commitments and communicating status updates on the completion of the FDA 483 Response Commitments to FDA.

First Phase

For the first phase you need one of the best Consultants with extensive FDA experience who rose to a high enough level at FDA that they understand the FDA Inspection process and the FDA Compliance review process.? They need to have experience within FDA determining FDA Inspection final ratings (NAI, VAI, OAI) and know how FDA will assess the need for further regulatory action (Untitled Letter, Warning Letter, and other forms of “restrictions” and legal actions).? You need someone who understands how FDA thinks and what they will expect to see in the FDA 483 Response.? This is not someone who has had 2 to 4 years of FDA Investigator experience.? This is someone with deep, broad, and lower to upper to senior level experience with FDA.? You also want to be sure this Consultant has had consulting experience with a proven track record of successfully preventing Warning Letters and/or clearing Warning Letters efficiently and effectively for their clients.? Lastly, this “unicorn” needs to be able to teach, coach and mentor at all levels within their clients’ organization.? They need to be able to partner with consultants who have deep rich industry experience to engineer sustainable and efficient solutions linked to the strategy of the business.

For the first phase you also need a consultant with extensive experience leading, responding to, and leading FDA 483 Response Remediation Plans within a company.? Do not select someone who says, “I never had a serious FDA Form 483 issued to my company under my watch because we were near perfect.”? This is not real and a “reality TV star” will not enable you and your organization.?? Hire an industry expert who has deep, broad GxP knowledge who has some battle scars and who has learned some hard lessons.? While they may not have created the issues that led to the serious FDA Form 483 Observations or Warning Letter(s), they need to have deep experience leading a(an) organization(s) out of a crisis with sustainable good results. ?They need to have experience collaborating with their peers on the executive/senior leadership team, driving changes in quality culture and creating a business value for Quality and Compliance.? This individual is also a “unicorn” and will be hard to find.

These two “unicorns” should have a solid working relationship and work well together bringing the best of their experiences to bear on the 483 Response Strategy and written Response.

Second Phase

For the second phase you need these two “unicorns” to oversee and lead the remediation, working closely with the executive/senior level management of your firm.? These individuals should remain with the project to manage the additional “issues” that will emerge as the remediation progresses.? I have never seen a remediation project in which new “issues” do not emerge.? The two individuals who supported the development of the FDA 483 Response Strategy and written Response should manage regular updates to FDA on the progress of the 483 Response commitments and should prioritize the actions needed on new “issues” identified using risk management principles.? One of the most important things these two “unicorns” must manage is scope creep; there must be laser focus on effectively completing the 483 Response commitments so there are no repeat Form 483 Observations in the next FDA Inspection.? Repeat Observations are the fastest way to a Warning Letter, Corporate Warning Letter, or worse (Consent Decree).

In addition to the two “unicorns”, you need consulting resources to design protocols, lead remediation activities, write reports, and lead/write investigations and CAPAs which fully meet FDA expectations as part of the overall remediation effort.? These are consultants with deep subject matter expertise who have a proven track record of completing 483 Response commitments on time and within budget.

?Lastly, you may need “staff augmentation”.? The are additional staff that execute day to day work while the remediation program is executed.? Select qualified individuals who can be managed by your team who work collaboratively side-by-side with your employees.? If you work in a large organization, consider offering “development opportunities” to high potential employees who are seeking to broaden their experience base.

What other Factors Should You Consider to Avoid the “Meh” or Bad Experience?

Big is not always the best.? The biggest Quality and Compliance consulting firms do not always create bespoke solutions that are designed to enable your business strategy.? They often have templates and standardized approaches.? They do not have the best consulting talent; their focus is on quantity and not quality.?? The biggest consulting firms will staff a project with a large number of average consultants.? It can and will be expensive.? You may feel like your organization is literally “crawling” with consultants.

Individual Consultants may not have the ability to assemble an expert consulting team for phase two of the remediation project when more than one individual is needed.? They can be of high value when one “unicorn” is needed, and a supporting team is not needed.? They can provide deep analysis, develop strategies, and create a framework the organization can execute.

The “boutique” Quality and Compliance consultants are able to create bespoke solutions that are designed to enable your business.? These are the medium-sized firms.? They are able to develop clinical stage-appropriate quality processes and systems for start-up companies that are primarily outsourcing.? They are able to adapt regulations to novel products, breakthrough therapy products, combination products, and unique challenges/situations.? When these firms are selected for remediation projects, they tend to assemble a small “tiger team” of consultants with very high levels of expertise and deep experience. The advantage of the “tiger team” approach tends to be less expensive overall, and these seasoned experts are excellent at building capability in your organization.? They are excellent coaches and mentors, and they will leave your organization stronger than when they arrived.? They draw in more of your team in each “work stream” or remediation project so your staff learns from them “on the job”.?

When the Curtain Drops…

The ending is determined by the choices made as the First Scene closes.? Choose your Quality and Compliance consulting support wisely.? Meet with the large firms; include the “boutique” firms; do not stick with one firm out of loyalty or familiarity.? Be selective.? Demand “good”.? Do not settle for “Meh” and do not tolerate “Ugly” because the firm has a big brand name.? In my years in Industry as a senior leader/executive in Quality and Compliance I tried some of the biggest firms and I tried some of the “boutique” firms.? I had the most success with “boutique” firms.?? When I retired from a long and deep industry career and decided to consult, I joined a “boutique” firm so I can offer my clients the best of my experience.? I bring change management, team development, cultural development, process excellence, lean, and other elements into my work with clients when needed because I was fortunate to have that kind of training and development as part of my experience working for a company like Johnson & Johnson for over 27 years.? I can also bring “scrappy” and practical solutions to my clients due to my early career experience working for Chiron Corporation when it was a small biotech start-up company in the Bay area.? In a large consulting firm, I would not likely be able to bring the best of my total experience. ?I would need to standardize my approach to their overall standard approach.

Quality and Compliance remediation programs are expensive, they are stressful, and there is a lot at stake.? Choose your Quality and Compliance Consultants carefully and wisely.? Do not settle for “Meh”.? Seek out the best.? You are making a BIG investment.

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www.compliancearchitects.com

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