Compliance Insight, Inc. specializes in regulatory affairs and quality assurance services for FDA-regulated industries, offering hands-on compliance solutions with over 150 years of combined experience. The company provides a range of services including audit preparation, regulatory consulting, training, and project management, tailored to meet both operational and compliance needs. Founded in 2000, Compliance Insight has a proven track record of successfully navigating and resolving compliance issues for clients in the pharmaceutical and medical device sectors.

1. 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
Compliance Insight, Inc. 513-860-3512

2. 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.

3. 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
Compliance Insight, Inc. 513-860-3512

4. Experience
 US FDA/EU Regulatory bodies
 DEA
 USDA
 Due Diligence
 New Construction
 Training
 Validation
 QA/RA
 Chemistry
 Microbiology
 Virology
 Part 11/CSV
 Six Sigma

5. Experience
Parenterals
LVP
SVP
Orals
tablets
capsules
liquids
APIs
Creams/Ointments
Cosmetics
Sunscreens
Health and Beauty
Care
Foods
Biologics

6. 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.

7. 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

8. Services, Capabilities and Unique Benefits
GMP/GCP/GLP (GXP) TRAINING
Is 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 CONSULTING
Our 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 PROGRAMS
Our 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.

9. 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

10. Cosmetic and
Consumer 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 catastrophic
financial downfall and loss of a major client.

11. Medical Device
Warning Letter Resolution
Compliance 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.

12. Canadian Medical
Device License
Medical Device 510k & Canadian License Applications
A 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.

13. API Compliance
ISO 9000 to Q7a Conversion
The 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.

14. Compliance Insight, Inc. 513-860-3512
Global Pharmaceutical
Manufacturing Compliance
European Manufacturing Facility
A 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

15. Compliance Insight, Inc. 513-860-3512
Pharmaceutical
Consent Decree Resolution
Pharmaceutical Company with Consent Decree
A 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 the
project with systems functioning within acceptable parameters

16. Global API Compliance
New API Facility in China
CI 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.

17. 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.

18. 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.

19. Once we get started...
Periodic conference to discuss status (weekly,
monthly, etc.)
Timeline established and agreed upon
due dates
milestones
Final written report provided, as needed
We help find the issues and provide the
solutions!
Compliance Insight, Inc. 513-860-3512

20. 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
Compliance Insight, Inc. 513-860-3512