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Regulatory Compliance/Technical Services Provider Information Form
General information
Name of Organisation Pharma-Bio Serv
Contact information Head of Organisation – VP Europe Operations
Main contact - As per head of org.
Name: Conor McGauran
Address: Unit 2, 11 Euro Business Park,
Little Island, Cork.
Telephone: 021 461 9034
Fax:
Email: [email protected]
Web Site: www.pharmabioserv.com
Brochure (please attach if available):
Name:
Address:
Telephone:
Fax:
Email:
Summary of Experience in Industry
20 years successful track record of experience - 320+ full-time Consultants
Markets covered include USA, Europe and APAC Target audience - Pharmaceuticals, Biotechnology and Medical Technology sectors
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Consulting Experience
Regulatory Compliance
FDA/GMP Regulatory Compliance/Quality Systems/GXP
Quality Risk Management: ICH Q10
Regulatory Agencies Registrations: We are US Agents
Systems Based Approach Compliance: Quality, Laboratory Controls,
Packaging and Labeling, Production, Materials, Facilities &
Equipment
Post Approval Changes and Regulatory Compliance Assessments
Regulatory Enforcement Corrective Actions / cGMP Plans to meet
483's, Warning Letters, Consent Decree commitments
Pre-approval Inspection Readiness (PAI)
Quality Systems Compliance Audits: Investigations / CAPA; Change
Control; Annual Product Reviews (APR's), Complaints, SOP's &
Quality Policies; Calibration, Preventive Maintenance, Validation,
Laboratory Systems, Audits
Risk Analysis
The QA Pyramid Compliance
cGMP, GXP Auditing / Compliance / Training
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REGULATORY COMPLIANCE (contd.)
Regulatory Agencies Regulations Compliance Assessments:
- US: FDA, EPA, DEA, CBER, CDER
- PR: DSPR, ASSMCA
- Canada: Health Canada
- European: EMEA, MHRA
- Ireland: Irish Medicines Board (IMB)
Pharmacopeias: USP/NF; EP, JP
ICH: International Conference Harmonization Guidelines
Compliance
NDA/ANDA/CMC Filings Compliance Audits
Stability Protocols and Stability Programs
Packaging and Labeling Regulations
Complaint Reports and Investigations / CAPA
Regulatory Filings Requirements (US, International) during Products
Transfer or Post Approval Changes
Evaluation/Assessment of Validation status and
Validation/Qualification Documents Assessment
Standard Operating procedures Development and /or translations
Benchmarking / Gap Analysis
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REGULATORY COMPLIANCE (contd.)
Pre-FDA submission reviews
Controlled Substances Security programs
Product and Packaging Component Specifications
Change Control Procedures
Annual Product Reviews/Annual Product Reports
Batch Records Reviews/Revision/Verification for compliance to filings
(NDA/ANDA/CMC Section)
GAP Analysis, Remediation Plans and Implementation
Regulatory Consulting
Third Party Audits and Vendor Qualification
- Vendor Audits
- Software
- Equipment Manufacturers
- API's
- Raw Materials Supplies
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Technology Transfer
Technology Transfer Strategies
QbD: ICH Q8 Quality by Design
ICH Q9 Risk Management
Tech Transfer/Process Change Filings
New Product Introduction
New Technology Introduction
Process Development
Process Characterization
Manufacturing Process Gap Analysis
prior to transfer to a new facility
Process Research and Design of
Experiments
Components and Composition
Site Changes
Equipment Changes
Packaging Changes
Label Changes
Changes in Batch Size
Manufacturing Changes
Changes in components
CBEs, Annual Reports, Pre-
Approval Submissions for NDAs
PAI Readiness
PAI Mock-ups
New Product Launch Support
Batch Records Development &
Revision
SOPs Development
Process Analytical Technologies
(PAT) and New Trends
Risk Based Approach to
Technology Transfer
SUPAC/ BACPAC
Equivalency Assessment
Pre-formulation Services
Formulation Development
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Commissioning & Qualification
Green Building Commissioning
Manufacturing and Packaging
Equipment Qualification
(IQ,OQ,PQ)
Design Qualification (DQ)
Maintenance System
Qualification
Utilities Qualification
Facilities Qualification
FAT / SAT
Risk Assessment
Risk Management: Direct vs.
Non-Direct Impact; Critical Vs.
Non-Critical
Commissioning and Enhanced
Commissioning
Decommissioning
Integrated Validation Approach
Suppliers / Materials
Personnel
Instrumentation
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Validation
Manufacturing Process Validation (PV)
Packaging Process Validation (Pkg V)
Cleaning Validation (CV)
- Clean-ability Studies
- Detergents Evaluation
- Sanitizing Agents Studies
- Recovery Studies
- Microbial Load
- Active Drug Solubility and Sampling
- Surfaces Areas and Sampling Points
- Holding Times (Prior and Post Cleaning Process)
- Worst Case Studies
- Bracketing
- New Approaches to Cleaning Validation
Analytical Methods
Validation (MV)
Analytical Methods
Transfer
Software Validation and
CSV
21 CFR Part 11
Network / IT Infrastructure
Validation
Risk Based Validation
Validation Master Plans
Process Support /
Monitoring
Maintenance of Validated
Status
Re-Validation
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Computer Systems Validation
Computer Systems Validation Protocols
Controls / Automation / Integration
21 CFR Part 11 Gap analysis / Assessment
21 CFR Part 11 Corrective Action Plans
System Development Life Cycle Management (SDLC)
Control of Changes
Computer Validation Master Plans
Factory Acceptance and Site Acceptance Tests (FAT / SAT's)
User Requirement Specifications (URS)
Traceability Analysis Matrix (TM)
Functional Specification (FS)
Design Specification (DS)
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COMPUTER SYSTEMS VALIDATION (contd.)
Software Vendor Audit & Report
C&Q Protocols: IQ, OQ, PQ
Source Code Review and Testing
Standard Operating Procedures (SOP's)
- Contingency Plan
- Change Management
- Disaster and recovery plans
- Annual System Review
Development Test Plans & Report
Validation Reports
System Classification Forms
Impact Assessment / Risk Management
Computer Systems Validation Methodology
Computer Systems Validation Procedures
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Quality Risk Management
Interpretation and Application of Quality Risk Management
Guidelines (e.g. ICH Q9, ASTM, ISO) to your industry
Documentation – review current interpretations and application of
regulatory expectations (SOPs, guidelines, etc.)
Training and Education
Auditing/Inspection
Risk identification and control (application of tools such as FMEA,
FMECA, FTA, HAZOP, etc.)
Periodic reviews to interpret and analyze monitoring data
Change management and change control
Leverage testing from Commissioning (Enhanced Commissioning)
Eliminate redundant paperwork during qualification
Reduce test cases based on risk assessments
Interpretation and Application of new standards based on Risk Based
Approach
Streamline practices and procedures
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Project Management
Capital Projects Management
Technology Transfer Projects
New Facilities Start Up
Commissioning & Qualification
Project Timelines Development
Strategic Planning
Scheduling (MS
Project/Primavera)
Cross Functional Team
Development
Test Plans and Field Execution
Resource Loading and Allocation
Integrated Approach
Project Meetings
Project Documentation Controls
Strategic Planning
Project Management Tools:
- MS Project
- Primavera
Project Control Metrics
Financial Control/Budgeting
Project Progress Reports
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Other Divisions
Microbiological Testing
Microbial Limits Test
USP Organisms
Microbial ID (Fungi and Bacteria)
Sterility Test
LAL Test
Anti-microbial Effectiveness Test
Media Preparation
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Microbiological Testing (contd.)
Environmental Testing and Monitoring
Particulate Testing
Water Testing
Cleaning Validation
Bio-burden Analysis
Swab analysis
Compressed Gases Sampling and Testing
Chemical and Physical Testing:
pH
Total Dissolved Solids / Total Chlorine
Conductivity
Assay
Impurities / Content Uniformity
Dissolutions
Total Organic Carbons
Titrations / Water Content
Particle Size
Residual of Evaporation
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Chemical and Physical Testing (contd.):
Residual Solvents / Residual on Ignition
Specific Rotation
Drug Content
Peroxide Level
Acidity / Strength / Purity
Identifications (Various)
Loss on dry
Heavy Metals
Viscosity
Cleaning Validation
TLC
Additional Services
Methods Validation
Methods Verification
Methods Improvement
Methods Development
Sanitizations
Stability Storage and Test (Microbiology and
Chemistry)
On site Lab cost assessment for Lab Operation
cost reduction
Laboratory Technical Training
Development of Stability Protocols
Disinfectant Validation
Materials Sterilization
Special Projects
On-Site Pick-Up
Laboratory Analyst Certification
Additional tests available upon request
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Training Experience
ICH Guidelines for Product Life Cycle
ICH Q7A – GMP Guidance for API ICH Q8 – Pharmaceutical Development – Quality by Design ICH Q9 – Quality Risk Management ICH Q10 – Pharmaceutical Quality Systems
Risk Management Program
Quality Risk Management Certification ICH Q9 – Quality Risk Management Risk Assessment Tools Risk Based Approach to Cleaning Validation Risk Based Approach & Quality by Design: Technology Transfer Risk Based Approach to Commissioning and Equipment Validation Risk Based Approach to Laboratory & Quality Systems Risk Based Approach to CSV
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Validation Courses
Achieving Validation Excellence-Validation Academy: 8 modules for certification Validation Concepts and Technical Writing Documentation Enhanced Commissioning & Risk Based C & Q Process Validation Today and Tomorrow: New FDA Guidance Draft Process Validation for Biotechnology Manufacturing Process Validation for Parenteral Manufacturing Process validation for Medical Device Process Validation for Solid Dosage Forms Cleaning Validation in Sterile Manufacturing Cleaning Validation in Non-Sterile Manufacturing CSV- Computer Software Validation Life Cycle Technology Transfer based on Design Space ICH Q8-Quality by Design and ICH Q9-Quality Risk Management Validation Documentation Requirements and Change Control System
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Regulatory Guidance Documents
Guidance for OTC Human Drug Products Manufacturing Quality Systems Inspection Techniques Effective Laboratory & OOS / OOT Investigations Introduction to PAT 21 CFR Part 11 Sterile Drug Product Produced by Aseptic Processing Stability Testing Guidance SUPAC and CDER Guidelines applications on Technology Transfer Bar Code & Labeling Requirements Process Validation Guideline Cleaning: Regulatory Requirements & Inspection Approaches Impact of Non-Compliance in Biotechnology Industries
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Quality Systems
ICH Q 10 Pharmaceutical Quality Systems Annual Plant cGMPs Technical Writing for Pharmaceutical Professionals How to Structure Effective SOPs & Train Personnel Good Documentation Practices Root Cause Analysis and Problem Solving Techniques for Investigations Conducting and Writing Investigations: Effective Investigation Techniques and Technical Writing Effective Technical Writing Report Preparation Developing Effective Corrective Actions and Preventive Actions (CAPA) Effective Change Control System Regulatory Requirements and Compliance Processes for Medical Devices. How to Implement Effective Quality Systems How to Improve the Batch Record Auditing Process Compliance Auditing: How to Conduct Effective Audits
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Lean Six Sigma / Process Excellence and Continuous Improvement Series
Introduction to 6 Sigma and Process Excellence Six Sigma for World Class Manufacturing Six Sigma Green Belt Certification Six Sigma Black Belt Certification Application of Six Sigma in Validation Life Cycle Building a Lean Thinking Culture Introduction to Statistics Introduction to Process Capability Introduction to Design of Experiments Introduction to SPC & Process Capability for Continued Process Verification
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cGMPs
ICH Q 7A – GMP Guidance for API cGMPs Applied to Processing Areas cGLPs Applied to Laboratory Areas cGMPs Applied to Engineering Areas cGMPs Applied to Material Control Areas Personnel & Quality Management Responsibilities Building a Quality Compliance Culture Good Documentation Practices for Drug and Food Industries Good Laboratory Practices (GLP’s)
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Information Management & Technology (Integratek Division)
Track record in: Custom Application Development Systems Integration
Technology Project Management System Implementation.
Over 10 years of Application Development Experience: CRM
Workflow Management Portals
Self Service Centers
SAP
Dynamics
ERP Integration projects
E-Learning Systems
