Cynthia Ipach, President and CEO
The first question for any FDA regulated industry is “How do you know you’re in control?” In the current regulatory scenario, superior Quality Assurance (QA) and Regulatory Affairs (RA) support for FDA (Food and Drug Administration) regulated products is critical for the development and approval process for prescription drug, biologic, device, and combination products. Stakeholders involved in the lifecycle of product development are bound to ensure clinical development, design, monitoring, and control. The core components of Good Manufacturing Practice (GMP), Good Clinical Practices (GCP), and Good Laboratory Practice (GLP) (collectively known as GXP) are written as regulations and implemented by the FDA. Inability of stakeholders to implement and execute the core components of GXP leads to serious compliance issues and regulatory actions against stakeholders. This is where Compliance Insight, Inc. (CI) comes in.
It was in the year 2000, Cynthia Ipach, a serial entrepreneur, started the company to offer QA and RA services to the pharmaceutical and medical device industries. Having more than two decades of experience in FDA-regulated industries, Cynthia says, “I began CI with an aim to establish a ‘quality culture’ in an organization, which considers all of the stakeholders in a serious situation. The culture needs to be established at the top of the organization so everyone understands the company’s identity.”
Since its inception, CI has been transforming the FDA regulated industry with their core expertise on FDA regulations and a team of over 50 subject matter experts from industry and the FDA. Every skilled professional has practical, hands-on experience providing RA and QA services over the lifecycle of the product. CI works with the stakeholder to proactively prevent or resolve FDA compliance issues by assisting with:
•Implementation of quality systems
•Handling inspections, regulatory filings or FDA 483 and Warning Letters
•Providing specific and focused compliance training so firms can readily adhere to the regulations and quality changes
CI experts offer real world examples and options so that stakeholders can make an informed decision when it is time to choose options for resolutions that fit their culture and context. “Our consultants are located across U.S. and Canada, offering support for FDA compliance issue resolution, executing audits ranging from Mock FDA to due diligence or CRO audits as well as an array of training courses and the full range of regulatory submissions,” asserts Cynthia.
Your On-Call Compliance Team
According to Cynthia, quality professionals are often barraged with compliance issues for a specific site or globally on a daily basis. These issues or “burning fires” can range from a contaminant in a production batch to a stability failure or a surprise FDA visit. “Every company needs a quality professional who understands the risks of each situation including potential risks that patients face, opportunities to detect the issue, and other regulatory risks to name a few key points,” she adds.
We actively engage and align with our clients to move beyond the regulations to compliance that makes sense for their culture and unique operations
For start-up companies and virtual companies, the option of having some or all of the QA functions and responsibilities being managed and performed by a “Virtual QA” is a viable alternative in terms of efficiency and cost savings. CI provides Virtual QA functions with round the clock assistance accessible via a multitude of means of communication. Virtual QA also provides instant support by skilled professionals without increasing overhead count.
Recently, CI worked with a large pharmaceutical firm under Consent Decree to completely overhaul their quality, operation, utility, investigation, CAPA, and warehouse systems. Over the life of this assignment, CI colleagues operated as the site QA Manager, interim Quality Director, and QA Oversight to foster continual quality improvement. “We had direct interaction with the FDA during audits and provided guidance towards viable pathways to compliance offering the required Quality Oversight for the first product to be approved for manufacturing and shipment,” adds Cynthia.
Experts at Handling FDA Situations
Organizations supported by CI offer resounding commendation for the timeliness and quality of work performed. CI understands that compliance issues can and usually result in lost revenue or unfavorable press for any organization. CI’s FDA Response Team’s goal is to resolve the issues and restore a firm’s compliant standing with the FDA in as little time as possible. “We start by assigning compliance specialists that have the experience and core expertise to resolve the situation. We first analyze the situation and determine the options to move forward,” explains Cynthia. “Immediately after the analysis, we act as mediators and extended members of the client’s team to provide hands-on execution of clearly defined endpoints.” CI professionals establish and execute processes that assist the client to implement and maintain compliant programs.
Additionally, CI provides QA and RA knowledge to compounding pharmacies that want assistance in registering as outsourcing facilities and need help to keep their business in good standing with regulatory agencies. The Drug Quality and Security Act of 2013 allowed FDA to audit compounding pharmacy operations. CI received many requests for help. “The area that seems to be the most problematic for the compounding pharmacies is creating, maintaining, and/or testing a sterile environment that meets FDA expectations,” adds Cynthia. “We assist the compounding pharmacies in navigating these regulations that can be both cumbersome and costly for facilities providing these services to physicians and consumers.” To focus on quality improvement in organizations, CI is rolling out a quality culture program called “Complete Mastery” which is designed for executives. For the road ahead, CI is also planning to provide additional value for the industries they serve through on-site courses, public speaking at seminars, and webinars. “As the regulations are created or updated and the focus of FDA changes, we will continue to update our colleagues so that they can ensure that our stakeholders are meeting their compliance goals,” concludes Cynthia.