Case Studies and Testimonials - A Demonstration of Our Expertise and Level of Service
In the highly regulated world of medical devices, IVDs and Combination Products, excellence is not measured by promises, but by a proven quality and regulatory compliance track record. Our case studies and testimonials offer transparent proof of how we navigate complex compliance landscapes and deliver sustainable market success for our partners.
CORRECTIVE & PREVENTIVE ACTIONS (CAPA)
CHALLENGE: IVD CAPA Warning letter
A global IVD manufacturer received multiple Warning Letters for an inadequate CAPA program and a backlog of over 1,100 open CAPAs.
SOLUTION:
The CAPA process and CAPA governance were revised and global training was provided. We oversaw the new process for a period of 2 years.
OUTCOME:
The Warning Letters were cleared. We significantly improved root cause investigations, CAPA content quality and CAPA timeliness. There was a substantial reduction in the number of open and repeat CAPAs (from over 1,100 to less than 100 in approx. 2 years).
RISK MANAGEMENT
CHALLENGE: Prep for EU MDR and QMSR
Complying with EU MDR & QMSR laws requires significant changes in clinical evaluation, risk management, general safety and performance requirements, supplier management, post-market surveillance, and more. A global Medical Device manufacturer was late in preparing for the most recent regulations. Most importantly, they did not have a Risk Management process for the total lifecycle of their products.
We provided training for management and targeted business functions, performed a gap assessment, created a project plan, templates and automated PM tools, revised processes and procedures and SMEs partnered with their employees to remediate the risk management files of over 200 products (18 major product lines).
SOLUTION:
OUTCOME:
Risk Management Review was implemented for the total product lifecycle and linked from Clinical Evaluation through Post-Market activities. Products have received EU MDR CE-Marks. Risk-based processes have led to cost savings in operations, and the firm is ready for their next FDA inspection based on QMSR.
Key Engagements and Outcomes
Important Note: Our staff personally led each of these projects prior to the formation of J Michener Whipple & Partners LLC. These are first-hand accounts of our experience.
COMBINATION PRODUCTS
CHALLENGE: FDA Classified it as a Combo Product
A European pharmaceutical manufacturer submitted a New Drug Application (NDA) and was notified by the FDA that it was a Combination Product and they needed to implement a Part 4 compliant QMS prior to the Pre-Approval Inspection (PAI).
SOLUTION:
We performed an initial gap assessment and created a project plan to implement a comprehensive Combo Product QMS. We provided training and leadership advisory services to assist the manufacturer in creating the necessary processes, procedures and records. Prior to the PAI, we performed a readiness assessment along with inspection prep services.
OUTCOME:
The PAI was successful with no observations and ultimately the new combination product was approved by FDA.
PROJECT MANAGEMENT
CHALLENGE: Product Acquisition and New Product Introduction
A smaller start-up sized organization was struggling to bring their initial product to market and at the same time, the Private Equity that owned them acquired an additional similar product for them to integrate into their portfolio.
SOLUTION:
We provided Project Management tools, a project manager and leader to assist with organization, prioritization and execution of the Quality and Regulatory tasks that needed to be accomplished. We further provided a Design Transfer Checklist and assisted in taking both products through the transfer and commercialization process.
Today, both products are successfully on the market and sales are growing. In addition, the company was recently acquired by a major Medical Device manufacturer. The Design Transfer template has become a tool and a template that they continue to use due to its overwhelming success.
OUTCOME:
COMPLAINT MANAGEMENT AND REPORTING
CHALLENGE: Complaint Management FDA 483
A global manufacturer had a serious 483 observation for inadequate complaint investigations, a large backlog of aging complaints and inadequate Medical Device Reporting (MDR).
SOLUTION:
The Complaint process and procedures were revised (intake, investigation, MDR and closure) and training was provided. We led a team of consultants to remediate 2 years of MDR and also clear the backlog of open complaints.
OUTCOME:
The 483 was closed and no Warning Letter was issued. We significantly improved complaint management efficiency and timeliness. There was a substantial reduction in the number of open complaints and none more than 30-days aging by the time the project was completed.
ENFORCEMENT REMEDIATION
CHALLENGE: Warning Letter, Class1 Recall and Public Safety Notice
A US company was marketing COVID products globally without market authorization. FDA issued a Warning Letter, Class 1 Recall and a Public Safety Notice on the same day. They were further investigated by the FDA Office of Criminal Investigations and the DOJ.
We quickly provided an interim Quality and Regulatory staff, established and implemented a complete QMS system, gathered the necessary data and filed pre-market submissions to the countries where the products were being marketed. We helped to interview and hire full time employees (FTE) and trained them in the processes that had been established.
SOLUTION:
OUTCOME:
A complete QMS was implemented from scratch in less than a year. The Warning Letter was closed. FTEs took responsibility, and in the following year, FDA and EU granted market authorization.
INTERNAL AUDITS & ANNUAL GMP TRAINING
CHALLENGE: Annual requirements not met
This final case study represents 2 clients who consistently had difficulty meeting their annual requirements for Internal Audits and GMP training. One was a smaller organization operating virtually with a remote staff using a Contract Design and Manufacturing Organization (CDMO). The second was a major manufacturer of multiple products including drugs, devices and combo products.
In both cases the clients hired us to perform comprehensive internal audits, including an audit of the CDMO, to manage any CAPAs that resulted from the audits, and to perform annual GMP training year over year.
SOLUTION:
Compliance was maintained by outsourcing Internal Audits and GMP refresher training to us on an annual basis.
OUTCOME:
QMS INTEGRATION
CHALLENGE: Multiple QMS systems and Procedures That are Conflicting
A major manufacturer of Medical Devices, Pharmaceuticals, Companion Diagnostics and Combination Products had grown through mergers & acquisitions. There were multiple QMS processes and systems, and some were conflicting. This was especially difficult for functions that cross multiple organizations such as Purchasing and Distribution.
OUTCOME:
We performed a series of audits, specifically to identify gaps and best practices. We created a cross-functional, cross-business unit team and held Kaizen events to harmonize processes and procedures. We facilitated change management and provided organizational training. Finally we implemented KPIs for harmonized Management Review.
Processes were optimized and harmonized throughout the company providing efficiency cost savings and flexibility. Operations were ensured of sustainable compliance.
SOLUTION:
Client Perspectives on Compliance Success - Testimonials
"The consulting services provided were instrumental in delivering on our project commitments. We couldn't have done it without them. I would highly recommend partnering with them again."
VP of Operational Excellence
"Before our inspection concluded, I was already in contact with the consulting team for assistance. I was very impressed by how quickly they responded."
Sr. VP of Quality & Regulatory
"Janet’s project management skills are second to none. She is organized, has great attention to detail and at the same time keeps clear the big picture and the strategy. Her guidance and follow-up were critical to successfully completing important projects for the company."
general manager and site leader
"Janet is a conscientious manager and her people skills are excellent. She listens and communicates her expectations clearly. She is a pleasure to work with."
Senior quality manager
"We never could have cleared the Warning Letter without the consulting team. Their expertise transformed our approach to FDA inspections and responses."
Vice President of operations