} Dietary Supplements } Medical Devices } Nutraceuticals } Raw Materials (USP, NF, Technical Grade, Industrial Grade)

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2 WHY CHOOSE US? Our unique brand allows our clients to enjoy a diversified level of Regulatory Compliance based on product life cycle principles. We are recognized by our clients for offering quality services in all projects, following the most rigorous standards, and continuously maintaining professionalism throughout the duration of the project. Subject matter experts with decades of experience serving Fortune 500 companies in GLP, GCP, GMP and GVP environments, stand ready to meet client needs for project or program-based initiatives. We don t require a long learning curve, which translates into faster payback and a greater return on your investment. Whether your company is seeking to design and implement a Quality Management System (QMS) from the ground up or to reinforce and strengthen the effectiveness of your existing QMS, Compliance X Consulting can serve as your strategic partner. Contact us today! PRODUCT EXPERTISE } Pharmaceuticals } Biotechnology } Vaccines } Blood Fractionation } APIs } Dietary Supplements } Medical Devices } Nutraceuticals } Raw Materials (USP, NF, Technical Grade, Industrial Grade) LEAN & SIX SIGMA METHODOLOGIES AND TOOLS The professionals at Compliance X Consulting have served as architects of highly-effective Continuous Improvement programs and initiatives, capturing gains in efficiency, productivity, and operational effectiveness, that have produced millions of dollars in cost savings. } Operations and Quality Strategy with Goal Deployment } Lean Leadership, influence model, and culture change } Lean methodologies and tool Playbooks, coaching guides, training materials, and exercises focusing on Process, Performance, People, and Technology } Visual management and performance boards for manufacturing, quality/lab, and office } Role Clarity (RACI) diagnostic and implementation } Lean Lab (Productivity improvements, Risk Management, Mistake Proofing, performance management) } Expert facilitation and brain storming techniques } SIPOC, Value Stream mapping, swim lane, and other process mapping } Process waste identification and root cause analysis } Voice of the Customer } 5S organizational effectiveness and efficiency } Overall Equipment Effectiveness (OEE), Tact, and other productivity improvement techniques } DMAIC problem solving, Regression Analysis, DOE, and other statistical based analysis tools } Sales and Operations Planning optimization } Cost to Serve supply chain } Pull based inventory management and replenishment } Integrated Margin Management } Design to Value Packaging System analysis

3 QUALITY BY DESIGN ORGANIZATION } Organization design & effectiveness } Quality organization design FACILITIES } Capital project conceptualization & implementation } Design of facilities & equipment } Design pilot plants } Layout of production, formulation and secondary/packaging STRATEGY } Product development technology strategies } Formulation & methods development } Regulatory submissions } Prepare complete BLA submissions } Support PAI readiness } Product & method optimization } Product quality performance assessment } Process analytical technology support CLINICAL & SAFETY } Clinical study design & data analysis } Pharmacovigilance processes } Audits of third party service providers } Clinical Laboratory Practice (GCLP) compliance service } Site Audit } Data Base Audit QUALITY, AUDITING & COMPLIANCE } Presentations to FDA, other regulators } Preparation of global policies, standards and guidance } Quality system design } Pharmacovigilance systems & programs } Clinical study evaluations } Regulatory audits & risk assessment } Remediation planning & implementation } Investigations } CAPA } Change Controls } Batch records } Validation } Aseptic Techniques } Disposition of product } Standard Operating Procedures } Data Integrity } Tech Transfer

4 Training Curriculum NEW HIRE ORIENTATIONS } Introduction to the Industry } Introduction to the GMPs } Personal Responsibilities } Everyday Compliance } US vs Barr Labs Case GLP SKILLS } Overview of the GLPs GCP SKILLS } Overview of the GCPs ICH Q7A GMP REFRESHERS } Accountability } Documentation } GMP Top Ten } Attention to Detail } Cross Contamination } Labeling and Product Mix-ups } Recent Audit Findings } Why Do We Verify } Yes but! Compliance Refresher GMP SKILLS } General Overview } Each Subpart } For Specific Groups } IT } Maintenance } Metrology } Validation } Facilities } QA/QC } Manufacturing } For Specific Topics } Discrepant Materials } Annual Visual Reserve Samples } Change Control } Data Integrity } Discrepant Materials } Hold Procedures } Sampling } Stability } Materials Management } Cleaning and Cleaning Validation } Cross Contamination and Cleaning DOCUMENTATION SKILLS } Good Documentation Practices (plus a separate refresher) } Log Books } Batch Record Documentation } Documentation of Process Data } Rounding and Truncating Rules } Raw Data } Deviations/Investigations } Risk Based Decision Making } Root Cause Analysis } Problem Solving TECHNICAL SKILLS } Sampling } Sterile Filtration } Annual Visual Reserve Inspections } Sterilization and Dehydrogenation VALIDATION SKILLS } Basics of Validation } Analytical Methods } System Validation } Validation Master Plan REGULATORY SKILLS } Field Alerts } Inspection Readiness } Pharmacovigilance } Reportable Events } Responding to 483s } Writing a 483 Response } SCARs } Device Submittals } Export Controls SAFETY SKILLS } Lock Out/Tag Out Training } Use of Fire Extinguishers MANAGEMENT SKILLS } Motivation } Leadership } Group Dynamics } Climate } General Systems Theory } Force Field Analysis } Managing Managers } Coaching/Development } Delegation } Managing Change } Project Management } Perceptual Distortions the Pygmalion Effect PROFESSIONAL SKILLS } Time Management } Etiquette } Interviewing Skills } Managing Your Boss } Stress Management } Writing Skills } Public Speaking } Auditor Training } Career Planning } Conducting Effective Meetings } Etiquette compliancexconsulting.com

5 Training Curriculum COMMUNICATION SKILLS } Questioning Skills } Assertive Skills } Active Listening } Communications & Listening Workshop } One-on-One Communications QA SKILLS } Change Control } Raw Data } Material Control } Risk Based Decision Making } Quality System Audits } Batch Record Review QC SKILLS } Cleaning Glassware } Log Books } Lab Inspections } Environmental Monitoring } Dissolution Wizard } Moisture Balance Training } Chromatography } OOS } Introduction to Microbiology TECHNICAL SKILLS } Aseptic Gowning } Powered Lift Equipment } Sterile Filtration and Filter Integrity Inspections COMPUTER SKILLS } Microsoft Office Suite, including } Excel } Word } PowerPoint } Learning Management Systems, including: ISOTrain Compliance Wire Success Factors (formerly Plateau) CBT Authoring Software, including Lectora Camtasia Document Management Systems QUMAS Master Control TOTAL QUALITY MANAGEMENT SKILLS } Lean Manufacturing } Blue Belt Training } TQM TRAINING SKILLS } Train-the-Trainer } Four hour, 1 day, 3 day, and 5 day versions } Course Development Process } Training Manager Workshop CRITICAL AREAS RETRAINING } Aseptic Room Workers } Batch Record Reviewers } Labeling and Product Mix-ups ENVIRONMENTAL, HEALTH & SAFETY SKILLS } Blood Borne Pathogens } Contractor Safety Training } CPR-AED } First Aid } Shift Work } Lab Safety ON-THE JOB TRAINING } By definition, OJT is specific to each job training OPTIONS All Comliance X Consulting Training includes: training materials, assesments as well as case studies for your training needs. Training can also can be devolped to cater to your organizational needs, contact Compliance X Consulting today. CALL FOR PRICING 2 HOUR TRAINING COURSE 4 HOUR TRAINING COURSE 8 HOUR TRAINING COURSE TRAINING WITH AN INSTRUCTOR P.O. Box Weymouth, MA (1) info@compliancexconsulting.com

6 REGULATORY SERVICES For clients with regulatory concerns, CxC focuses on supporting the company in rebuilding or protecting its reputation. } Support and certification for 483s, Recalls, Warning-Letters and Consent Decrees } Consulting on regulatory requirements and interpretation } Prepare response strategies and reports } Attest to agencies on client progress } Independent third party activities } Audits } Review and certify } Clinical/Bioequivalence Studies } Product License } Validation } Facilities } Laboratories } Investigations } Batch Records } Management Controls } Product Complaints } 483 response and corrections } Completed remediation plans } Facilities and Equipment } Corporate and site policies, standards, guidelines and SOPs } Due Diligence Assessments Company Engagement Awarded Top 25 Compliance Service provider for 2016 ABOUT US Compliance X Consulting offers exceptional services in the areas of Regulatory Compliance and Quality for the regulated industry in accordance with the latest FDA/EMA/Health Canada and other international agencies regulations and guidelines. We specialize in Inspection Readiness, Regulatory Compliance (Warning Letter and Consent Decree), Good Laboratory Practices, Good Clinical and Pharmacovigilance Practices, Lean and Six Sigma methodologies and tools, and Manufacturing Operations with a proven track record of success. In order to provide our customers with the best professional services, our team of Subject Matter Experts (SMEs) is up-to-date with the latest developments on all applicable Regulations, both at Federal and Local levels. At Compliance X Consulting, we are prepared to help you achieve full compliance in all the Regulatory and Quality Compliance aspects of your organization. P.O. Box Weymouth, MA (1) info@compliancexconsulting.com