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} 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
LEAN & SIX SIGMAMETHODOLOGIES AND TOOLS
PRODUCT EXPERTISE} Pharmaceuticals
} Biotechnology
} Vaccines
} Blood Fractionation
} APIs
} Dietary Supplements
} Medical Devices
} Nutraceuticals
} Raw Materials (USP, NF, Technical Grade, Industrial Grade)
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!
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.
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
CONSULTING
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
Training Curriculum
compliancexconsulting.com
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
DOCUMENTATION SKILLS} Good Documentation Practices (plus a separate refresher)
} Log Books
} Batch Record Documentation
} Documentation of Process Data
} Rounding and Truncating Rules
} Raw Data
§211.192} 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
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
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
} Email Etiquette
} Interviewing Skills
} Managing Your Boss
} Stress Management
} Writing Skills
} Public Speaking
} Auditor Training
} Career Planning
} Conducting Effective Meetings
} Email Etiquette
CONSULTING
2 HOUR TRAINING COURSE
4 HOUR TRAINING COURSE
8 HOUR TRAINING COURSE
TRAINING WITH AN INSTRUCTORCALL FOR PRICING
Training Curriculum
training OPTIONS
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
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
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
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.
P.O. Box 890194Weymouth, MA 02189
CONSULTING(1) 888-562-9022
www.compliancexconsulting.com
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.
ABOUT US
REGULATORY SERVICES For clients with regulatory concerns, CxC focuses on supporting the company in rebuilding or protecting its reputation.
P.O. Box 890194Weymouth, MA 02189
} 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 EngagementAwarded Top 25 Compliance Service provider for 2016
CONSULTING(1) 888-562-9022
www.compliancexconsulting.com
CONSULTING
