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A presentation about Compliance Insight Inc and our services. For more information go to http://compliance-insight.com/about-us/

A presentation about Compliance Insight Inc and our services. For more information go to http://compliance-insight.com/about-us/

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  • System redesign, incorporating workable solutions such that the company could sustain compliance with cGMPs: deviation investigations, OOS investigations, CAPAs, document control, change control, method validation, equipment/instrument qualification/validation. On-site presence every day – interaction with employees provide daily reassurance and guidance.

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  • 1. Compliance Insight, Inc.Introduction Compliance Insight, Inc. offers hands-on effective, value-added compliance solutions We specialize in QA and RA services nationally andinternationally for FDA regulated industries Our services are practical, straight-forward and easilyimplementedCompliance Insight, Inc. 513-860-3512
  • 2. Overview, History & OrganizationOur dedicated team has over 150 years ofcombined knowledge and experience in FDA-regulated industries.Compliance Insight, Inc.Cynthia Ipach, President of Compliance Insight,Inc., founded the company in 2000 with thegoal of offering hands-on Quality Assurance(QA) and Regulatory Affairs (RA) services to thePharmaceutical and Medical Device industries.Compliance Insight, Inc. 513-860-3512A year later co-owner and Vice President, Troy Fugate, joined the company.Since that time, Compliance Insight has grown to include ComplianceSpecialists with a variety of background experiences. Our recent additionsinclude very detailed personnel dealing with clinical audits and data review.
  • 3. Value Proposition• Each consultant has 15+ years “in the trenches” experience within FDAregulated industries• Ability to get around the “politics,” “chatter,” and “roadblocks” thattypically 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 entireprogram at each firm compliant with GMPs• Taking into consideration that the firm needs to be operational as well ascompliant, we work diligently to bring systems into compliance quickly andefficiently• 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 arecompliant, functional and “really work” as opposed to theoretical fixesthat look good but cause issues elsewhere in the companyCompliance 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 BeautyCareFoodsBiologics
  • 6. Services, Capabilities and Unique BenefitsAUDIT SERVICES• PAI Preparation Audits – Be preparedand confident when the FDA visits• Supplier/Contract Manufacturer – Meetyour SOP audit commitments• GMP Gap Analysis - establish yourcompliance level with industry standards• Laboratory Audits – Ensure that theChemistry, Microbiology, or Viral labmeets GMP/GLP standards.• Due Diligence - evaluate your nextacquisition before purchaseREGULATORY CONSULTING• Regulatory Filings--IND, NDA,ANDA, 510k, Supplements, AnnualReports• FDA Liaison – Ask FDA questionswith complete anonymity or haveus meet with FDA on your behalf• 483 Resolution/Warning Letter/Consent Decree Response –CI can write andsupport the response.Compliance Insight is a group of highly-trained Quality Assurance andRegulatory Affairs professionals with proven track records in a variety ofFDA regulated industries.
  • 7. Services, Capabilities and Unique BenefitsAdditional 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 BenefitsGMP/GCP/GLP (GXP) TRAININGIs GXP a way of life at your company?Our Training Programs can provide ahands-on solution to your trainingneeds.In-house GXP Training--our trainer willcome to your location!Annual GXP Training--a wide variety oftopics to choose from!New Employee Orientation--to bringyour new hires up to speed!BIOSAFETY CONSULTINGOur Biosafety Consulting services canprovide clients with the expertise neededto design and develop global regulatoryproduct testing strategies at all stages ofproduct development.ACCREDITATION PROGRAMSOur 20-week Quality AssuranceAccreditation Program is targeted toemployees with five years or lessexperience and is conducted by one-hourtelephone coaching calls. With thisprogram, clients can provide theiremployees with the skill sets necessary tomake quality-conscious and compliantdecisions.
  • 9. Services, Capabilities and Unique BenefitsFirms with Regulatory issues(483, Warning Letter or CD)• Our firm has the ability tocontain the situation, provideinterim controls sufficient tobring operations back up to acompliant state and/or tosatisfy FDA compliance issuesand deal with long termresolutions to the situation• Our goal is to re-establish thefirm’s credibility with the FDAFirms without Regulatory issues• We can provide short term gapresolutions to any specificproject that may require GMPcompliance knowledge• We can serve as your trainedand experienced work force onan as-needed basis rather thanhiring full time staff• Our goal is to maintain yourcompliance status with theFDAWe strive above all else to be value-added to your firm
  • 10. Cosmetic andConsumer ProductsMajor Health Care Product ContractManufacturer in Mid-West• Temporary QA Department for a Cosmetic and Consumer Productscompany.• Actively worked on investigations (a) internal-(Deviations, Un-Plannedincidents) 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 ensurecompletion including effectiveness checks.Compliance Insight, Inc. executed changes to increase the company’sQuality Score by 40%, saving the company from catastrophicfinancial downfall and loss of a major client.
  • 11. Medical DeviceWarning Letter ResolutionCompliance Insight was contacted by a medical device manufacturing company tohelp 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 warningletter 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 issueswere addressed satisfactorily.The follow-up inspection by the FDA was a success.
  • 12. Canadian MedicalDevice LicenseMedical Device 510k & Canadian License ApplicationsA foreign manufacturer of Class II in-vitro diagnostic devices, seeking to market theirproducts in the US and Canada, turned to Compliance Insight for assistance. Working closelywith the client’s US agent, we prepared and submitted a number of 510k applications to theFDA as well as license applications to Health Canada. We took the following approach toenable 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 equivalenceto predicate devices per FDA requirements.• Participated in the coordination, management and review of data from additionalclinical 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 devicesin the US and Canada.
  • 13. API ComplianceISO 9000 to Q7a ConversionThe client, a medium size chemical company, wished to produce an API (activepharmaceutical ingredient), for sale in the EU. They already supplied chemicals tonumerous pharmaceutical facilities under ISO 9000 standards. They needed site-widetraining to close the gap between their current ISO 9000 system and the ICH Q7a GoodManufacturing Practice Guidance for Active Pharmaceutical Ingredients.A training program was implemented covering the Q7a Guidelines so that all employeesreceived a consistent understanding of the FDA requirements.Subsequently, the company’s Quality Systems were reviewed. Established short andlong term corrective actions to close the existing gaps.The client successfully completed their Q7a implementation plan.
  • 14. Compliance Insight, Inc. 513-860-3512Global PharmaceuticalManufacturing ComplianceEuropean Manufacturing FacilityA US firm acquired a manufacturing facility in Europe. All systems at the facilityhad to be evaluated and variances from current GMPs remediated. The projectspanned 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 preventcontamination• Laboratory system streamlined• Warehouse system modernized for GMP complianceHosted successful FDA audit and responded to initial list of 483observations effectively to gain approval for manufacture anddistribution within the US
  • 15. Compliance Insight, Inc. 513-860-3512PharmaceuticalConsent Decree ResolutionPharmaceutical Company with Consent DecreeA large Midwestern solid oral dosage form company contacted CI for help in compliancewith 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 – allprocedures 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 DirectorCI provided Quality Oversight for the first product to be approved formanufacture and shipment post Consent Decree. CI completed theproject with systems functioning within acceptable parameters
  • 16. Global API ComplianceNew API Facility in ChinaCI was hired to establish Quality Systems, file all Regulatory submissions and manageValidation activities. The facility was constructed in rural China. The project spanned 1.5years during which time the following occurred:• Facility utilities, manufacturing equipment, and the API process were successfullyqualified and validated• All Quality Systems were established• Provided GMP training for multiple subjects including ICH Q7a, Validation, GDP, APIprocess• Drug Master File was submitted and acceptedCI was able to work with language, cultural, and regulatory differences to the completesatisfaction of all involved. The Prior Approval Supplement for use of the APImanufactured at the facility was approved by the FDA.SFDA invited CI to hold ICH Q7a training for Asian industries interested in marketing tothe U.S.
  • 17. Dietary SupplementLaw SuitCI was engaged by a law firm to conduct audits and investigations on international facilitiesto 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 enduser.All 26 facilities were evaluated and findings shared with the law firm. A probable sourceof contamination was identified.
  • 18. Process, Computer andCleaning ValidationValidation OversightCI 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 andcleaning 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 establishedAll 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 theprocess 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 thesolutions!Compliance Insight, Inc. 513-860-3512
  • 20. Conclusion: Why Choose Us? We make certain that compliance issues are properlyresolved We will make sure you are completely satisfied – wevalue 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 resultsCompliance Insight, Inc. 513-860-3512