Regeneron Pharmaceuticals Blue Mountain

Anthony Armstrong Andrews

*** ******* *****

Dallas, Georgia 30132

678-***-**** / *.*********@*******.***

Summary:

A highly-trained quality conscious Calibration/Metrology/Equipment Qualification/Validation Engineer with over 10+ years of working experience with communication skills, drive, and a vision to infuse a quality culture throughout the organization. Core strengths includes but not limited to: Manage remediation of (4) consent decrees, manage vendor quality systems, translate trend data into quality guidelines, administer corrective and preventative actions, Anticipate risk on quality processes, Re-engineered WIP for greater ROI, obtain ISO-17025 certification to reduce cost of equipment service contracts, conduct investigations (laboratory and manufacturing) to ensure adherence to the quality program. Knowledge and experience developing, writing and executing validation lifecycle documents in the following disciplines facilities, laboratory equipment, commissioning, installation, qualification and validation activities for both solid dose or aseptic processing environments. Maintain clean utility systems, water purification systems, filling lines, cleaning equipment, depyrogenation ovens, sterilization equipment, packaging, and stability storage equipment to reduce product cross-contamination.

PROFESSIONAL EXPERIENCE:

AmbioPharm Incorporation

1024 Dittman Court

Beach Island, South Carolina 29842

Calibration/Metrology Validation Consultant (Metrologist III)

Oct 2021 to Dec 2021

Review of junior metrologists (4 technicians) executed (CI) Calibration Instructions and (PMI) Preventative Maintenance Instructions for Quality Control Product Release Laboratory Systems to ensure compliance and adherence with cGMP, Data Integrity, local and federal regulatory agency regulations. Develop, write and execute validation protocols with oversight from Quality, Facilities, Automation and Production departments, collect data and compare to established acceptance criteria. Draft and submit final validation summary reports to Quality Unit for approvals. Develop, write, review and update new, existing standard operating procedures to reflect daily operational practices. Perform gap analysis and re-validate equipment, component or systems to provide a high degree of assurance that the current validation processes ensure compliance to local policies, standard operating procedures or regulatory requirements. Perform annual re-qualifications/validation of lyophilization systems used for freezing drying of proteins, perform monthly, quarterly, semi-annual and annual recertification for balances, refrigerated, frozen and ultra-freezer storage units, conduct training for junior metrology staff on validation principles, methodology and execution activities.

Wuxi App Tec

1265 Kennestone Circle

Marietta, Georgia 30066

Equipment Validation Specialist/Metrology SME

26 Jul 2021 to 30 Aug 2021

Perform Installation, Operational, and Performance Qualification including cycle development, loading configuration determination and remediation of an existing water system to used support three existing sterilizer and a newly purchased and installed Steris 630 sterilizer. Perform annual re-qualifications, for balances, refrigerated and freezer storage, perform training of junior metrology staff on validation activities.

Develop, write and execute validation protocols, collect data and compare to established acceptance criteria, draft and submit final validation summary reports for approval.

Perform gap analysis and re-validate equipment, component or systems to provide a high degree of assurance that the current validation processes ensure compliance to local policies, standard operating procedures or regulatory requirements.

AbbVie Pharmaceuticals

North Chicago, Illinois

Project Calibration Engineer

Oct 5, 2020 to 03 Apr 2021

Site Lead responsible for migrating (16) sixteen newly acquired site’s (BMRAM) existing Blue Mountain Regulatory Asset Database into AbbVie’s Maximo Calibration and Maintenance Asset Management System.Duties included but not limited to, attending conference calls, creating object structures to migrate assets, locations, tolerances, frequencies and calibration events. Participate in cross-function teams in South America, North America (Waco, Texas, Branchburg, New Jersey Europe and Ireland. For 16 newly acquired sites. Responsibilities included identification of assets, mapping the migrated fields, creation of datasheets to migrate calibration points, development of the object structures used to upload the required fields. Serve as the “SME” Subject-Matter Expert for Calibration/Metrology and Validation teams.

ThermoFisher Scientific

Contract Manufacturing Facility

5900 Martin Luther King Jr. Hwy

Greenville, North Carolina

Feb 10, 2020 to 27 Apr 2020

Black Diamond Network

C&Q Validation Engineer II

Lead commissioning, (FAT-Factory Acceptance Testing and SAT-Site Acceptance Testing) activities to include installation qualification of a Harro Hölfliger Automated Powder Syringe Filling System, new suite and commissioning rooms and supporting utilities. Write qualification documents to support all qualification phases to include (FAT/SAT/IQ/OQ/PQ when applicable.

Perform installation and operational verification during factory and site acceptance testing. Verify that the qualification protocols are adequate and demonstrate the compliance of the system with URS, cGMP, system technical and functional requirements.

VALSOURCE LLC (CQV Consultant)

918A Horseshoe Pike

Downingtown, PA 19335

Commissioning/Qualification Engineer

Lonza Biologic, Inc.

14905 Kirby Drive

Houston, Texas 77047

Mar 18, 2019 to Nov 01, 2019

Review existing SOP documents, calibration results, validation protocols (IQ, OQ, PQ) for Automation and Computer System Validation to determine if these documents require remediation. Also, review Automation Computer System against (21 CFR part 11) compliant requirements for Electronic Records and Electronic Signatures (ERES) and Data Integrity (DI) confirming to FDA regulations.

Perform Installation and Operational Qualifications and Final Summary Reports for Biosafety Cabinets, Freezers, Refrigerators, Scales, Balances, AKTA Chromatography Columns, CliniMacs Plus Instruments, CO2 Incubators, Inspection Stations, High Flow Peristaltic Pumps, Orion PerpHect Meters, Carbon Dioxide Distribution Systems, Nitrogen Distribution Systems

Prepare commissioning and qualification documents, validation protocols (IQ, OQ, PQ) including designing appropriate test plans. Perform the execution of validation protocols of an existing Purified Water (PW), Water for Injection (WFI), and Environmental Monitoring System (EMS), and SCADA systems that is (21 CFR part 11) ) compliant for Electronic Records and Electronic Signatures (ERES) and Data Integrity (DI) consistent with FDA regulations. Performed technical reviews for the equipment, and commissioning documenting its process capabilities for production requirements.

Prepare written commissioning and qualification documents, validation protocols (IQ, OQ, PQ) including designing appropriate test plans. Developed URS, FRS, and DQ’s for support of (SAT, IQ, OQ) in order to perform the execution of validation protocols of an existing Purified Water (PW), Lab equipment, Calibration Management SOP, instrument numbering SOP, equipment gap assessments, HMI and SCADA systems for (21 CFR part 11), CSV Risk assessments, compliant for Electronic Records and Electronic Signatures (ERES) and Data Integrity (DI) and Temperature Mapping SOP’s that confirms to FDA regulations. Perform technical reviews for equipment and process capabilities for production equipment requirements.

Knowledge of best calibration practices, management, and industry standards for instrument calibrations and calibration documentation for process control instrumentation and lab-based instruments, pressure, temperature, level, flow, differential pressure, magnetic resonance, vortex, and flow transmitting products, (IP/PI pneumatics transducers); load cell, and on-line continuous monitoring, and analytical measurement products, etc. Maintains a working knowledge of automation valves, pressure reducing regulators, used in aseptic processing, Maintain BMS (Building Management Systems), critical parameters for site process utilities (PW, PS, WFI, CA, etc.) process automation using analytical instrumentation.

Voestalpine Automotive Components Inc

21 Voestalpine Drive NE

White, Georgia 30184

Feb 28, 2019 to 15 Mar 2019

Quality Auditor Supervisor

Manage team of quality auditors responsible for reducing the number of defective parts in Cold Form, Press Hot Steel, Assembly and Safe Launch departments.

Duties included conducting hourly checks to ensure operators, sorters and internal quality auditors performed periodic inspections using calibrated instruments, check fixtures and reference parts to minimize defects.

Conduct oversight inspections of third party auditors to ensure parts being shipped to customers met internal and customer specifications.

Evaluate weekly and monthly defect reports to ascertain causes and implement corrective actions to reduce bent flange rework, rust/oil deficiencies, blooming, missing/wrong part numbers, incorrect part numbers, burs, holes of location, excessive oil, torn flange, incomplete weld and other non-conforming attributes.

Train operators and sorters to identify non-conforming parts to reduce waste, scrap and rework.

Evaluate reference parts for damage and submit to CMM labs for replacements when necessary.

Reduce third party auditing staff by implementing operator verification steps to halt production when non-compliance is detected.

Lyophilization Services of New England

5501 Research Triangle Boulevard

Madison, Wisconsin 53719

Jan 14, 2019 to Feb 8, 2019

Carlton National Resources

Validation Engineer

Reporting to the Validation Manager III, duties include generating, developing validation protocols and reports, compiling data packs, and analyzing data for adherence to established acceptance criteria. Conduct validation execution for mixing, filling, formulation, and visual inspection and lyophilization studies. Perform execution of installation qualification protocols for pure steam system renovations in support of autoclaves, lyophilizers and process equipment. Author and execute validation protocols for automated Bosch Filling Line equipped with Vial Washer, Depyrogenation Oven, Vial Receiving Turn-table, Capper and Crimping Line.

Initiate and lead risk assessment, gap analysis and deviation management for investigations, remediate protocol generated deviations, complete reviews of software with focus on change control, deviation investigations,corrective and preventative to ensure compliance and validated state of the instrument. Reviews validation deliverables created by other departments for adherence to site validation SOPs and acts as validation approver as needed. Perform reviews of welding log reports, passivation reports, piping and borescope certificates, material of construction specs, test instrument/equipment certificates and piping and instrumentation diagrams in support of new and existing equipment. Conduct mapping studies using Kaye validator 2000, AVS Kaye Validator Valprobe wireless humidity, temperature and pressure mapping sensors.

Lohmann Therapy Systems Corp.

(Transdermal Market Leader)

21 Henderson Drive

West Caldwell, New Jersey 07006

Apr 09, 2018-Oct 12, 2018

Black Diamond Networks

Project Manager (Quality Technical Services)

Reporting to the Senior Manager of Quality Technical Services, my duties included, but not limited to preparation, review and approval of installation, operational and performance qualification protocols using USP41 and Handbook 44 requirements for balances, scales, top-loaders and floor scales used throughout the production and manufacturing suites.

Manage protocols pre-execution and post-execution approvals by stake-holders.

Manage qualification communication between the service provider and production managers for Coating, Fabrication, Formulation and slitting departments to ensure minimum interruption in the production schedules.

Responsible for the remediation of investigation to address vendor deviations generated during protocol execution, address vendor data integrity and good documentation concerns evaluate protocol results and ensure clear concise communications between the service provider and client.

Responsible for reviewing installation qualification, operational qualification and performance qualification test results.

Responsible for the resolution to exception condition or deviations generated during protocol execution and final reports.

Verified applicable standard operating procedures, operator’s manuals, logbooks, and preventive maintenance documents are in draft, approved or effective status.

Investigate protocol deviations and applicable resolution in a timely manner

Verified all calibration of critical process test equipment/instrument used during protocol execution.

Establish rationale, procedures and define conditions to determine re-qualification interval for process critical validated equipment, instruments or automated systems.

Conduct periodic review assessment of existing validation protocols to ensure routine re-qualification and periodic review assessment are conducted within their specified intervals.

Regeneron Pharmaceuticals, Inc.

81 Columbia Turn Pike

Renssselaer, New York 12144

Sep 13, 2015 –Dec 1, 2017

Oxford Global Resources, Inc

Engineer Consultant (IOPS Technical Operations)

Reporting to the Director of Engineering, my primary duties included oversight of critical process test instruments, calibration remediation; review of process critical parameters of systems and equipment within a 155,000sq/ft. FDA approved biotech manufacturing facility in upstate New York. Facility consists and operates in approximately 65,000sq/ft. of ISO 7 cleanroom space with approximately 4,000 instruments and systems.

Investigate, assess, and remediate over 4,000 critical process instruments within seven process areas. Conduct evaluations/assessments of instrument limits, calibration ranges, process ranges and specified use range to determine instrument suitability.

Conduct validation document searches to provide objective documented evidence to support the existing process parameters.

Provide engineering expertise in reviewing and updating (P&ID) piping & instrument diagrams to reflect flow path of the process areas.

Commissioning activities: calibration, qualification, and validation of newly installed process equipment such as bioreactor kitchens, (CIP) clean-in-place skids,(SIP) steam-in-place skids, clean utilities, steam generators, water for injection(WFI),purified water systems design, specifications, piping, and controls.

Manage multiple intermediate remediation projects such as flow transmitters, met-one particle counters, environmental chambers, weight transmitters

Assist with execution and review of (SAT) site acceptance testing, (FAT) field acceptance testing and completion of the documentation for newly installed equipment and systems.

Initiated over 1800 (EIURs) Equipment Information Update Requests in computerized maintenance management system (Blue Mountain Regulatory Asset Management Software) to update critical process parameters.

Conduct investigations, determine corrective and preventive actions to address non-conformances.

Initiate change control request to address changes to validated processes.

Review, determination, and approval of executed vendor validation documents to ascertain leveraging potential

Prepare, review of executed test plans to ensure recorded changes were documented.

Ensure workplace is clean and safe by enforcing company’s procedures, policies, and regulations.

Biotest Pharmaceuticals Corporation

5800 Commerce Park Blvd

Boca Raton, Florida 33487

Jun 1, 2015-Aug 09, 2015

ALKU Technologies Corporation

Calibration & Metrology Remediation Consultant (Subject Matter Expert)

Generate report to document facilities/engineering concerns to management. Monitor technical operations site-wide systems to ensure alignment and compliance with regulatory, industry, corporate policies and regulations.

Provide oversight for operation, maintenance and disposition of a multi building campus and associated manufacturing systems to assess warning letter findings and outlined remediation activities for capital improvements in calibration, metrology, utility maintenance.

Provide validation oversight for primary and secondary utility.

Verified all equipment, systems and devices during walk-down of facility, engineering and production systems.

Perform gap analysis of standard operating procedures to assess compliance with federal regulation and local requirements

Perform quality review of across multiple maintenance trades including electrical, heating, ventilation, air-condition, plumbing, equipment repairs and calibrations to ensure remediation and corrective actions for overdue work-orders.

Communicate metrology instructions between facility department and building maintenance groups.

Coordinate calibration and facility maintenance activities to include but not limited to: scheduling of vendors, resolving calibration problems and serving as subject matter expert providing technical support for internal/external departments to address such as investigations, deviations, change control, out of tolerances, environmental deviation that may have an impact on product quality.

Assess current calibration points, operating ranges and process tolerances based on validation parameters to ensure process equipment and instrument limits were uploaded accurately into SAP and CMMS.

Review in-house and vendor calibration standards accuracy ratio to ensure a minimum TAR of 4:1

Review and updates of P&ID(s) associated facility utilities, equipment and building management system layouts.

Review vendor certificates for accuracy, completeness and compliance with company policies.

Nanotherapeutics, Inc. (Contractor)

13859 Progress Boulevard

Suite 300

Feb 23, 2015 to 19 Mar 2015

Alachua, Florida

(Integrated Project Services) (IPS) (SME Compliance)-Commissioning/Qualification/Validation Engineer

•Responsible for providing support to the architectural and engineering design team during build-out of BSL-3 laboratory.

•Responsible for generation of (URS), process flow diagrams, piping and instrumentation diagram (P&IDs).

•Responsible for assessment of proposals and bid analysis for process equipment in analytical labs.

•Responsible for field support, equipment procurement and document submittal to appropriate management.

•Responsible for preparation and review of Engineering Turn-Over Packages.

•Responsible for preparation and submission of (SLIA), (ASIA), (CCA), (FAT), (SAT) and other supporting commissioning documents.

•Responsible for reporting CQV activities issue to the Director of Facilities and Engineering (SME).

Assist in developing measurement uncertainty limits and data collection forms for analytical and microbiological test instrumentation.

•Preparation and review of Project Validation Master Plan Equipment/System.

•Conduct Periodic Reviews for equipment, systems, and processes as assigned.

•Responsible for generation and execution of validation/revalidation protocols for new or legacy systems.

•Responsible for providing technical support/troubleshooting expertise to analytical lab staff.

•Responsible for writing summary reports..

•Responsible for developing testing strategies and rationale for instruments/systems.

•Responsible for analyzing validation results and verifying against acceptable criteria.

•Responsible for writing/updating standard operating procedures and work instructions.

•Responsible for leading remediation activities for deviations generated during engineering or validation studies.

GE Healthcare

Jul 28, 2014-Dec 19, 2014

3350 North Ridge Avenue

Arlington Heights, Illinois 60004

Metrology Engineer/Radiometrologist

• Metrology department Quality Reviewer for calibrations, maintenance (UWO) Unscheduled Work Order records to ensure correctness, completeness, consistency and accuracy using Track wise Preventive Maintenance module.

•Perform calibrations, re-qualifications, re-certifications and preventive maintenance activities to support production of radioactive medical devices (i.e. Iodine 123 and125, Indium and Thallium) and neurological diagnostic solutions (i.e. Datscan).

•Perform re-qualification and validation of all sterilization equipment (i.e. autoclaves, depyrogenation ovens, ethylene oxide and sterilizers), all laminar flow devices (i.e. hoods, bio-containment, workstations, enclosures with manipulators, controlled areas and various other pieces of equipment.(i.e. temperature measurement devices-thermocouples, thermometers, IRTDs, Electronic simulator/calibration devices-Beta Calibrators, multimeters, Laminar Flow Calibration devices-(i.e. Particle Counter, Photometer, Thermo anemometers High Efficiency Particulate Accumulator Filters), Ion Chambers, Gamma Spectrometers, Diameter Gauges Dial Gauges, Balances/Weight Set, Pipettors and dispensing pumps, Dimensionality test equipment-(i.e. micrometers, calipers, go/no go gauges, Pressure gauges and transducers). Perform temperature mapping studies on Refrigerators, and Environmental Chambers using Val Probe temperature sensors and software.

•Perform Humidity and Temperature sensor calibrations using (BMS) Building Management System; Kaye Validator 2000 with associated software and Intelligent Resistance Temperature Device. Conduct re-certification of (Class 100/ISO 5), (Class 1000/ISO 6), and (Class 10000/ISO 7) clean room regulated environments.

•Review/update calibration standard operating procedures and write SOPs for new equipment.

•Assure designated manufacturing and test equipment remains in a current state of calibration.

•Maintain filing system completely and concisely to support regulatory agency audits.

•Support validation, production and quality control departments in implementation of new equipment or processes which require calibration.

•Maintain aseptic qualification for controlled rooms and hoods.

•Improve existing calibration methodologies.

•Train junior Metrologist and technician in specific calibration practices

•Initiate OOT investigations and Change Control for equipment or processes found Out of Tolerance.

McNeil Consumer Healthcare

Jul 15, 2013 to Mar 14, 2014

3818 Colonial Village Drive

Lancaster, Pennsylvania 17603

Instrumentation Qualification Technician/Validation Consultant (QC-Laboratory Operations Subject Matter Expert)

Laboratory Instrument Specialist (served as Consent Decree Team Leader for Laboratory Operations)

•Serve as an expert and Project Lead for Lab Operations to ensure all key deliverables are met on schedule. Review and revise laboratory equipment qualification, calibration and maintenance programs to comply with established standards.

•Author site or multi-site standard operating procedures (SOP) for qualification, operation, maintenance or calibration of laboratory equipment/instruments.

•Evaluate site laboratory equipment/instrument qualification, calibration and maintenance documentation and processes to assure compliance with McNeil standards.

•Provide oversight and monitor progress on tasks assigned to other team members.

•Make team lead aware of any issues or roadblocks in a timely manner.

•Develop and/or execute protocols to assess suitability of laboratory documentation for qualification, calibration and maintenance activities.

•Participate, as needed, in investigation of non-conformances associated with laboratory equipment/instruments, assuring effective corrective and preventive actions are taken.

•Provide laboratory space and facility assessment(s) to assure adequate space and utilities for equipment/instrument needs.

•Assure accuracy of laboratory equipment/instrument lists.

•Collaborate with and participate in cross-functional meetings to assure continued alignment of laboratory/instrument practices with other quality system changes.

•Perform risk assessments and implement risk management tools to determine level of qualification, validation of incoming and existing laboratory equipment/instruments such as FTIR, GC, Karl Fisher,HPLC(s), Glassware Washer, Atomic Absorption Spectroscopy Top-Loading and Analytical balances, Shakers, Environmental Monitoring equipment such as RCS, Refrigerators, Freezers, Incubators, Autoclaves, Thermo cyclers and HVAC systems, etc.

•Upgraded Lab Calibration department to a paperless data management system through installation/implementation of SAP (R6) Maintenance and Facility software. Successful implementation increased compliance, efficiency and reduced man-hours by thirty percent.

•Approve, schedule, supervise external contractors performing onsite calibration, preventive maintenance, qualification, validations and upgrades on analytical lab equipment/instrument such as: Spectrophotometers, Incubators, Centrifuges, Balances and Pipettes.

•Support Microbiology Lab with assessment of existing equipment/instrument, design qualification for new equipment/instrument, protocol review for completeness, review of analytical data generated during execution (PQ) Performance Qualifications

•Support Microbiology management by working closely with contract engineers, process engineers, production supervisor and operators to support production.

PharmEng Technology-Ben Venue Laboratories

(Apr 23, 2012-23 May 2013)

300 Northfield Road

Bedford, Ohio 44146

Senior Validation Consultant

•Lead validation consultant, primary responsibilities were to organize, execute and supervise the day to day activities for validating the following equipment: (10) Hot Air (Depyrogenation) Ovens, (12) Moist Heat (Steam) Autoclaves and (2) Depyrogenation Tunnel Lines.

•Develop and Execute Installation Operation Qualification (IOQ), Cycle Development (CD), Performance Qualification (PQ) protocols and Tank Cleaning studies.

•Assign sterilization team members their daily tasks.

•Attend daily meeting with facility management team.

•Assist and guide clients in regards to validation approach.

•Reviewed (FAT) Factory Acceptance Tests and (SAT) Site Acceptance Tests and Commissioning reports.

•Write protocols for manufacturing equipment sterilization load patterns.

•Execute protocols and write supporting reports (i.e. summary and final reports)

•Performed pre and post calibration of thermocouples using Kaye Validator 2000 temperature monitoring units.

•Tests critical and key process parameters to assure reliability, quality and proper documentation to support the associated process and results.

•Executed cycle development and performance qualification protocols utilizing Kaye Report Wizard or Kaye generated data.

•Address and resolve deviations and corrective actions/preventive action (CAPAs) encountered during execution of protocols by investigating root cause.

•Working knowledge of EN285 and PDA Technical Report No.1 (Revised 2007) “Validation of Moist Heat Sterilization Process: Cycle Design, Development, Qualification and Ongoing Control”

•Submit post execution microbiological samples and sterilized filter assemblies to Quality Control for analysis.

•Compiled and draft final reports redline production standard operating procedures (SOPs) and draft final release statement.

•Perform cleaning validation on Parts Washer, Tray Washer, HEPA (High Efficiency Particulate Air) Carts, Vial Washers and 20 to 50 Formulation Vessels using Riboflavin and ultraviolet light detection.

•Responsible for reviewing cleaning validation rationale established for the entire facility.

•Draft final release statements for cleaning equipment.

Ciba Vision/Alcon

(Sept 19, 2011-Apr 13, 2012)

11440 Johns Creek Parkway

Johns Creek, Georgia 30097

QC Analytical Senior Metrology Instrumentation Specialist

•Manage instrument qualifications, validations and preventative maintenance programs for QC Analytical instrumentation.

•Manage service agreements, schedule calibrations and preventative maintenance with external and internal service providers.

•Manage approval process for calibration providers to include, but not limited to conducting audits to verify ISO, 17025 certifications.

•Draft SOP(s) qualification and validation protocols for new and existing analytical equipment and instruments.

•Provide technical support and troubleshooting expertise (SME) for GC, HPLC, Balances, pH meter, Stability chambers, Biomedical Refrigerator and Freezers, Refractive Index, FTIR, FTNIR and other disciplines.

•Assist and provide technical assistance to facility technicians responsible for maintaining the Facility Ultrapure Water, (USP) and WFI (Water for Injection) systems.

•Review and provide technical assistance for new equipment purchases to ensure the proper (URS, SDS, FDS) requirements and regulatory requirements are addressed satisfactorily before purchase is approved.

•Ensure all service providers have been proper vetted and has the proper documentation to provide service in a regulated environment.

•Data review for compliance to cGMP, 21 CFR Part 11, Parts 210 & 211, Part 58, Part 820 regulations and verification of processes and validation results.

Dendreon Corporation

(Oct 01, 2010-Nov 7, 2011)

Immunotherapy Facility

6715 Oakley Industrial Boulevard

Union City, Georgia

Senior Metrologist/Calibration Systems Specialist

Reporting to the Supervisor of Engineering & Metrology, I was charged with primary oversight of installation, operation, qualification and

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