Compliance Insight, Inc. 513-860-3512

Compliance Insight, Inc.

Introduction

Compliance Insight, Inc. offers hands-on effective, value-added compliance solutions

We specialize in QA and RA services nationally and internationally for FDA regulated industries

Our services are practical, straight-forward and easily implemented

Overview, History & Organization

Our dedicated team has over 150 years of combined knowledge and experience in FDA-

regulated industries.

Compliance Insight, Inc.Cynthia Ipach, President of Compliance Insight, Inc., founded the company in 2000 with the goal of offering hands-on Quality Assurance (QA) and Regulatory Affairs (RA) services to the Pharmaceutical and Medical Device industries.

Compliance Insight, Inc. 513-860-3512

A year later co-owner and Vice President, Troy Fugate, joined the company. Since that time, Compliance Insight has grown to include Compliance Specialists with a variety of background experiences. Our recent additions include very detailed personnel dealing with clinical audits and data review.

Compliance Insight, Inc. 513-860-3512

Value Proposition

• Each consultant has 15+ years “in the trenches” experience within FDA

regulated industries• Ability to get around the “politics,” “chatter,” and “roadblocks” that

typically impede a quick response to an FDA issue• Offering workable options that are compliant with required remediation • Looking beyond the observation to other systems and making the entire

program at each firm compliant with GMPs• Taking into consideration that the firm needs to be operational as well as

compliant, we work diligently to bring systems into compliance quickly and efficiently

• Capacity to speak to all levels of the firm – from the CEO to the mechanic – regarding GMP requirements

• Field experience to institute procedures company-wide that are compliant, functional and “really work” as opposed to theoretical fixes that look good but cause issues elsewhere in the company

Experience US FDA/EU Regulatory bodies DEA USDA Due Diligence New Construction Training Validation

QA/RA Chemistry Microbiology Virology Part 11/CSV Six Sigma

ExperienceParenterals

LVPSVP

Oralstabletscapsulesliquids

APIsCreams/Ointments

CosmeticsSunscreensHealth and Beauty

CareFoodsBiologics

Services, Capabilities and Unique Benefits

AUDIT SERVICES• PAI Preparation Audits – Be prepared

and confident when the FDA visits• Supplier/Contract Manufacturer – Meet

your SOP audit commitments• GMP Gap Analysis - establish your

compliance level with industry standards• Laboratory Audits – Ensure that the

Chemistry, Microbiology, or Viral lab meets GMP/GLP standards.

• Due Diligence - evaluate your next acquisition before purchase

REGULATORY CONSULTING• Regulatory Filings--IND, NDA,

ANDA, 510k, Supplements, Annual Reports

• FDA Liaison – Ask FDA questions with complete anonymity or have us meet with FDA on your behalf

• 483 Resolution/Warning Letter/Consent Decree Response – CI can write and support the response.

Compliance Insight is a group of highly-trained Quality Assurance and Regulatory Affairs professionals with proven track records in a variety of FDA regulated industries.

Services, Capabilities and Unique Benefits

Additional Services

• Project Management• New Construction Consultation• CAPA• Investigations• Viral Study Design and Review• Cleaning Validation Consultation• Validation Planning and Review• Customize Standard Operating Procedures• Risk Analysis• Viral Lot Release Testing

Services, Capabilities and Unique Benefits

GMP/GCP/GLP (GXP) TRAININGIs GXP a way of life at your company? Our Training Programs can provide a hands-on solution to your training needs.In-house GXP Training--our trainer will come to your location!Annual GXP Training--a wide variety of topics to choose from!New Employee Orientation--to bring your new hires up to speed!

BIOSAFETY CONSULTINGOur Biosafety Consulting services can provide clients with the expertise needed to design and develop global regulatory product testing strategies at all stages of product development.

ACCREDITATION PROGRAMSOur 20-week Quality Assurance Accreditation Program is targeted to employees with five years or less experience and is conducted by one-hour telephone coaching calls. With this program, clients can provide their employees with the skill sets necessary to make quality-conscious and compliant decisions.

Services, Capabilities and Unique Benefits

Firms with Regulatory issues (483, Warning Letter or CD)• Our firm has the ability to contain

the situation, provide interim controls sufficient to bring operations back up to a compliant state and/or to satisfy FDA compliance issues and deal with long term resolutions to the situation

• Our goal is to re-establish the firm’s credibility with the FDA

Firms without Regulatory issues• We can provide short term gap

resolutions to any specific project that may require GMP compliance knowledge

• We can serve as your trained and experienced work force on an as-needed basis rather than hiring full time staff

• Our goal is to maintain your compliance status with the FDA

We strive above all else to be value-added to your firm

Cosmetic andConsumer Products

Major Health Care Product Contract Manufacturer in Mid-West• Temporary QA Department for a Cosmetic and Consumer Products

company. • Actively worked on investigations (a) internal-(Deviations, Un-Planned

incidents) and (b) external (Customer Complaints). • Internal audits: all areas of operations of the plant (manufacturing,

packaging, warehousing) • CAPAs: followed up on corrective and preventative actions to ensure

completion including effectiveness checks.

Compliance Insight, Inc. executed changes to increase the company’s Quality Score by 40%, saving the company from catastrophicfinancial downfall and loss of a major client.

Medical Device

Warning Letter ResolutionCompliance Insight was contacted by a medical device manufacturing company to help with a warning letter for a number of significant GMP inspectional observations. The following steps were taken to establish regulatory compliance:• Prepared warning letter response with a time line to complete each observation. • Provided periodic status updates to the FDA for the issues stated in the warning

letter and notification of the remedial action taken in each case. • Trained all the employees on Quality System Regulations.• Established Quality Systems at all levels of the organization.• Prepared and implemented procedures as per Quality System Regulations. • Communicated with the FDA on a continual basis to ensure that all pending issues

were addressed satisfactorily.

The follow-up inspection by the FDA was a success.

Canadian Medical Device License

Medical Device 510k & Canadian License ApplicationsA foreign manufacturer of Class II in-vitro diagnostic devices, seeking to market their products in the US and Canada, turned to Compliance Insight for assistance. Working closely with the client’s US agent, we prepared and submitted a number of 510k applications to the FDA as well as license applications to Health Canada. We took the following approach to enable this manufacturer to legally market their products in both countries:• Identified appropriate predicate devices for FDA 510k applications.• Obtained and reviewed necessary documentation from the client.• Developed protocols for clinical studies needed to demonstrate substantial equivalence

to predicate devices per FDA requirements.• Participated in the coordination, management and review of data from additional clinical

studies required by FDA.• Successfully prepared and filed submissions to FDA and Health Canada.

The client now legally markets a number of in-vitro diagnostic devices in the US and Canada.

API Compliance

ISO 9000 to Q7a ConversionThe client, a medium size chemical company, wished to produce an API (active pharmaceutical ingredient), for sale in the EU. They already supplied chemicals to numerous pharmaceutical facilities under ISO 9000 standards. They needed site-wide training to close the gap between their current ISO 9000 system and the ICH Q7a Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

A training program was implemented covering the Q7a Guidelines so that all employees received a consistent understanding of the FDA requirements.

Subsequently, the company’s Quality Systems were reviewed. Established short and long term corrective actions to close the existing gaps.

The client successfully completed their Q7a implementation plan.

Compliance Insight, Inc. 513-860-3512

Global Pharmaceutical Manufacturing Compliance

European Manufacturing FacilityA US firm acquired a manufacturing facility in Europe. All systems at the facility had to be evaluated and variances from current GMPs remediated. The project spanned 2.5 years during which the following occurred:•Audit and remediation of USP Purified Water system anomalies•Training system completely remodeled•Investigation system brought to current FDA standards•Validation program implemented•HVAC controls established• Facility design and flow of material modified and improved to prevent contamination•Laboratory system streamlined•Warehouse system modernized for GMP compliance

Hosted successful FDA audit and responded to initial list of 483

observations effectively to gain approval for manufacture and

distribution within the US

Compliance Insight, Inc. 513-860-3512

Pharmaceutical Consent Decree Resolution

Pharmaceutical Company with Consent DecreeA large Midwestern solid oral dosage form company contacted CI for help in compliance with a US FDA consent decree. CI’s involvement included the following:• On site QA Plant Manager for two years• Completed quality, operation, utility, facility and warehouse systems overhaul – all

procedures and documentation• Direct contact with FDA during audits • Provided options and viable paths to be compliant• Did not overwhelm firm with auditors/consultants • Met all required dates for compliance activities • Served 1 year as OPS QA Oversight to assist with continual improvement process• Implemented new investigation process and CAPA program• Served as Interim Quality Director

CI provided Quality Oversight for the first product to be approved for manufacture and shipment post Consent Decree. CI completed theproject with systems functioning within acceptable parameters

Global API Compliance

New API Facility in ChinaCI was hired to establish Quality Systems, file all Regulatory submissions and manage Validation activities. The facility was constructed in rural China. The project spanned 1.5 years during which time the following occurred:

• Facility utilities, manufacturing equipment, and the API process were successfully qualified and validated

• All Quality Systems were established • Provided GMP training for multiple subjects including ICH Q7a, Validation, GDP, API

process• Drug Master File was submitted and accepted

CI was able to work with language, cultural, and regulatory differences to the complete satisfaction of all involved. The Prior Approval Supplement for use of the API manufactured at the facility was approved by the FDA.

SFDA invited CI to hold ICH Q7a training for Asian industries interested in marketing to the U.S.

Dietary Supplement

Law Suit

CI was engaged by a law firm to conduct audits and investigations on international facilities to remediate potential causes of contamination

• CI performed gap assessments of 26 contract manufacturers and contract laboratories. • CI investigated potential contamination of a dietary supplement ingested by an end

user.

All 26 facilities were evaluated and findings shared with the law firm. A probable source of contamination was identified.

Process, Computer and Cleaning Validation

Validation Oversight

CI was engaged by a large international firm due to FDA compliance issues regarding validation. The firm needed to re-execute all process, equipment, method, computer, facility, utility and cleaning validation protocols. • CI reviewed all protocols for GMP requirements. • Established a protocol format• Corrected the deficient parameters in the protocols • Completely re-formulated the cleaning program and implemented its validation• Performed all tasks in the time frames established

All protocols were successfully executed and the firm passed a subsequent FDA inspection.

The implemented cleaning program was successful to such a degree that the firm forwarded the process to other sites.

Compliance Insight, Inc. 513-860-3512

Once we get started...Periodic conference to discuss status (weekly,

monthly, etc.)

Timeline established and agreed upondue datesmilestones

Final written report provided, as needed

We help find the issues and provide the solutions!

Compliance Insight, Inc. 513-860-3512

Conclusion: Why Choose Us? We make certain that compliance issues are properly resolved

We will make sure you are completely satisfied – we value integrity

We are compassionate about what we do - compliance

We are committed to you – no changing the team

Your success is our main goal – you will see results