Consultoria, Talleres y Programas para Empresas En La Vanguardia

Para servicios de consultoria, diseño de Programas y Talleres llamar a Olga Lopez al 787-217-9606.

1.  Taller "Tu Vida en Proposito y Hacia el Exito" tiene como objectivo proveer unas tecnicas innovadoras para vivir una vida hacia el exito empresarial transformando estres, preocupaciones, ansiedades, depresion y hasta fobias, en una vida con proposito.  Promete un mejoramiento empresarial que integra  al empleado de una forma holistica, resolviendo sus inquietudes y preocupaciones mentales para que se enfoque en lo que es importante.

2.  Taller "Tecnicas asepticas durante la vestimenta esteril, en manufactura y llenado" 

3.   Servicios de Consultoria y por Contrato. Contamos con profesionales con mas de 20 años de experiencia. Para contrato llame al 787-217-9606.

Contamos con Profesionales experto en Sistemas de Calidad: Investigation System, Annual Product Review System, Complaints System, Validation System, Media Fill Program, Personnel Qualification Program, Trainng Program, Consent Decree Management, Cleaning Validation Programs, 100% visual Inspection Program, 

Sistemas de manufactura:  Manufactura de Parenterales, Liquidos y Soidos.:  Aseptic Filling,  Stoppers and Equipment Preparation and Sterilization, Vial Washing and Sterilizaton, Lyophilization cycles,  Terminal Sterlization, Autoclave cycles, 

Protocols developement for employee's skills assessment, Competency Assessment

  • Requerimientos Regulatorios para la manufactura de Productos Parenterales y productos Biológicos
  • Requerimientos Regulatorios de construcción de sistemas de agua y aire.
  • Diseño de Batch Records
  • Plan de Adiestramiento para Operadores, Supervisores y Managers
  • Diseño del Quality Plan
  • Revisión de Investigaciones para cumplimiento regulatorio.
  • Requerimientos de validación de Equipos y de Procesos.
  • Programa de Change Control
  • Diseño Organizacional
     

International, USA and PR Services.

787-217-9606  Bello BioPhar Olga López                                
 
 
Resume Olga Lopez                                                        
 
http://yogati.com/file/profesionales/olgalopezresume1.doc  

Olga María López

email olgalopez@yogati.com

email: bellobiophar@gmail.com

Cel.: 787-217-9606

SUMMARY

 

  • Extensive knowledge in FDA and European regulations in the Pharmaceutical, Medical Devices and Biotechnology industries. 
  • Lead positions in both Manufacturing and Quality Assurance include: supervisor, manager and director.
  • Extensive experience in various facilities startups for Parenteral, Solids, Medical Devices and Biotech products (Clinical Material production and Development of Vaccines and Proteins).
  • Manage Regulatory agencies visits at sites for approval after completion of three facilities start up in USA and Puerto Rico.  Vast knowledge in the design and validation requirements for utilities and equipment.
  • Perform Quality Assessments.
  • Develop and review deviations, investigations, CAPAs, change control and batch records.
  • Perform Clean Rooms and Microbiology laboratories processes inspections.
  • Worked actively in Remediation Plan, Investigations, CAPA’s, Procedures, Regulatory Inspection Readiness in pharmaceutical companies in USA, India and Mexico.

 

EMPLOYMENT HISTORY

 

Mar 2015 to Nov 2016

 

Independent Consultant for Pharmaceuticals

The Quantic Group, Ltd., Parexel and Quality Executive Partners at Sun Pharmaceuticals at Bangalore, RIMSA-TEVA at Guadalajara, Mexico and Unimed at Vadadora, India.

  • Quality Systems Assessments to several Quality Systems such as: Gowning and 100% Visual Inspection qualifications; Aseptic and clean area cleaning programs, Media Fill, and Training programs.
  • Revised Procedures for Labeling and Packaging, Aseptic Practices, Aseptic Filling, sealing and lyophilization.
  • Reviewed Investigations and CAPA’s as part of the Batch Record review for batch disposition.
  • Developed and Executed remediation plan.
 

EMPLOYMENT HISTORY (Cont’d)

 

  • Inspected Manufacturing areas for adequacy of equipment and facilities; compliance of processes with Federal Regulations, compliance with company and global procedures.   
  • Developed and run an employee skilled assessment program to identify employee’s skills, experience and knowledge. 
  • GMP audit to facilities and laboratories.
  • Reviewed the facilities Environmental Monitoring Program and designed strategies for improvement for locations, monitoring techniques, and reporting.
  • Participated in frequent meetings with Global Development Group to ensure procedures in all facilities were deployed timely and consistently for the implementation of new software, qualifications, and all revised programs. 
  • Developed an Aseptic Practices and Glove Integrity Testing training program based on employees, plant, FDA 483’s observations and warning letter and deployed to the three different Mylan/Agila sites.
  • Deployed training to employees and management. Revised Media Fill Batch Records, employee Media Fill qualification program, 100% Visual inspection program, Investigations, and Procedures for packaging and labeling.
  • Assessed the Microbiology Laboratory facility and testing processes to ensure compliance with Regulatory regulations, Good Laboratory Practices and Plant’s commitments.
  • Performed various lab facility and testing procedures audit until laboratory was in condition to be inspected by Regulatory Agencies. 
  • Developed flow charts for microbiology lab processes and environmental excursions.
  • Developed presentations for the Microbiology lab and Product Disposition to be presented to Regulatory Agency.

 

2011- 2015

          Independent Consultant for Pharmaceuticals

through The Quantic Group, Ltd at Pharmaceuticals at McNeil Las Piedras, Puerto Rico

  • Batch Record Quality System Assessment to ensure regulatory and commitments compliance.
  • Prepared and revised Investigations and CAPA’s.
  • Product Disposition Quality System Assessment.
  • Inspected manufacturing areas for GMP compliance.
  • Reviewed and revised Standard Operating Procedures (SOPs).
  • Revised Electronic Batch Record system implementation.
  • Assessed Annual Product Review and Complaints Programs.
  • Prepared finding reports, charts, trends, and recommendations.
  • Followed up FDA and plant commitments throughout the different Remediation plan groups: Validation, Quality Assurance, Engineering, Manufacturing.
  • Reviewed executed Batch Records for batch pre-disposition.

 

 

EMPLOYMENT HISTORY (Cont’d)

 

2002 – 2010

 

Director Quality Assurance, Associate Director

Wyeth North Carolina, USA and Guayama, PR

  • Managed and led the Quality Assurance Department for three major products on Batch Record review, Product Disposition, Validation of Equipment and Processes.
  • Review and Approval of Annual Product Reviews, Master Validation Plans, Complaints, and Investigations.
  • Reduced investigation closing rate to 2-3 days.
  • Reduced regulatory inspection observations to zero by training the QA personnel in the manufacturing processes and by maintaining QA closely involved in the manufacturing areas. 
  • Started up a new state of the art building (In North Carolina), hired a new QA group for all QA positions.
  • Initiated the Investigations/CAPA and Change Control Program,
  • Review and approved the Project Plan, Master Validation Plan, drawings, Validation/Qualification protocols and execution.
  • Initiated a successful program for QA employee’s recognition.
  • Achieved satisfactory FDA, European, Mexico and Japan inspections.

 

2001-2002              

 

Independent Consultant

Schering Plough at Manati, Puerto Rico, Wyeth at New York, North Carolina and Pennsylvania, USA

  • Assessed the following programs: Batch Records, Product Stability, Complaints, Investigation/CAPA and Annual Product Review.
  • Prepared reports for all assessments finding.
  • Charts progress for Complaints and Annual Product Review Programs.
  • Audited for GMP and regulatory compliance different facilities in Puerto Rico, North Carolina, New York, and Pennsylvania

 

1991 – 2000

 

Director Parenteral Manufacturing at MOVA Pharmaceuticals at Caguas, Puerto Rico

  • Managed and lead 16 supervisors and section heads to manage more than 100 employees in the different manufacturing areas:  Equipment preparation and Sterilization, Product Formulation, Filling of Parenteral, Final Sterilization, and 100% product inspection.
  • Managed three shifts 7 days/week, thee packaging department and the oral liquid department.
  • Prepared Investigations, CAPAs, reviewed batch records and ensure its timely completion for batch disposition.

 

EMPLOYMENT HISTORY (Cont’d)

 

1989-1991

 

Section Head Manufacturing of Injectable, Oral Liquids, 100% Inspection, Final product Sterilization and Packaging at MOVA Pharmaceuticals at Caguas, Puerto Rico

  • Supervised a total of 8 supervisors for three shifts in all manufacturing activities.
  • Completed two facilities validation and startups with successful FDA and European approvals.
  • In charge of batch record preparation and review, investigations and CAPAs for batch disposition.

 

 

1987-1989             

   

Parenteral Pharmaceutical Manufacturing Supervisor at Lyophomed Pharmaceuticals at Canovanas,  Puerto Rico

  • Started and completed the facilities start up and achieved successful FDA and European inspections. 
  • Supervised all manufacturing areas: Equipment cleaning and sterilization, formulation, freeze drying and filling of parenteral.
  • Prepared investigations and CAPAs and batch record review.

 

1982-1987 Lederle, Carolina, Puerto Rico       

 

Quality Technician to perform the sterility testing Supervised

the manufacturing of Parenteral products: Weighing and Formulation, Filling of Parenterals, Lyophilization and Capping.

 

Accomplishments:

ü  Developed sound Quality Systems in compliance with required regulations.

ü  Maintained a Parenteral production and Quality Assurance groups well trained and with complete knowledge on regulations requirements and aseptic techniques to ensure regulatory compliance.

ü  Obtained the regulatory approval (Federal, European, Mexico, Japan) for all sites where I completed the facilities start up:  Canovanas, Puerto Rico, Caguas, Puerto Rico, North Carolina, USA.

ü  Developed an overall training program for all employees from their induction to their operational level at Bangalore, India.

ü  Deployed the employee training program to three sites at Bangalore, India.

 

1978- 1982

 

GMP Auditor at Pharmaseal, Medical Device Company at Toa Alta, Puerto Rico

Performed sequential audit to medical devices manufacturing processes.  Reviewed Investigations and Corrective Actions. After two years was promoted to Sterility Test technician.

 

CERTIFICATIONS AND MEMBERSHIPS

 

PIA, PDA, Green Belt

 

EDUCATIÓN

 

Bachelor Degree in Science with concentration in Biology and Chemistry (minor)- University of PR

Master Degree in Marketing-(in-process)-Inter American University of PR

 
 
 
 
Resume Mariangeli Diaz
 

Mariangeli Díaz Salgado

15273 Westbridge Ct.

Henderson, MD 21640

M - (787) 501-4029

H - (443) 262- 8228

mariangeli.diaz@hotmail.com

 

Professional Background: 

Global Consultant with +26 years of experience in the Pharmaceutical, Biotech, Food, and Medical Device Industries. Extensive experience in Regulatory Compliance, FDA, ISO22000-2005/ISO 9001-2008/13485-2003, cGxP’s, OSHA, EPA, EHS, USP/NF, JP, EP, Quality Systems Part 210-211 & 820, Planning and Auditing, PFMEA and Risk Assessment evaluations, among others. Strong leadership skills with an analytical mind to solve quality issues. Ability to promote and maintain a high level of quality competence and staff motivation to accomplish objectives and meet deadlines.  Hands-on experience as Quality Assurance Manager, Technical Services Director, Change Control Manager, and Project Manager, with knowledge in Quality Systems, Validation, Manufacturing Operations, Product Transfer, and Regulatory Compliance programs. International work performed in USA, Dominican Republic, Mexico and Puerto Rico. Successful completion of million dollar projects through project estimate, planning, budgeting, cost control, implementation, execution and closeout. Built outstanding client relationships. Supervised, directly and indirectly approximately one hundred (100) manufacturing, quality, and validation professionals. Fully bilingual. Proficient in computerized systems such as: MS Office, Kronos, Project Management, SAP, JDE, ISOtrain, Documentum SOP System, and TrackWise System. Indian Business Visa, effective until Apr 2019.

 

Key Projects and Accomplishments

 

The Quantic Group, Ltd., Livingston, NJ,                                                                                                             2011 – Present

 Sr. Quality Leader on India sites - FDA Warning Letter Remediation

 

·         Independent third party - Regulatory Services Group

o   Quality Assurance Remediation Plan Lead

o   Establish and evolve formal QA processes, ensuring that the client follow industry-accepted best practices.

o   Oversee all aspects of quality assurance in 3 sites including establishing metrics, applying industry best practices, and developing new tools and processes to ensure quality commitments are met.

o   Act as key point of contact for all QA aspects to establish a site wise harmonization.  

o   Lead and mentor Site QA team members, as well as manage outside remediation team.

o   Develop and execute remediation protocols to full fill the sites commitments.

o   Review and evaluate performance issues with up to 10 direct reports

o   Interact with customers during meetings and visits

o   Collaborate with other Areas staff to accomplish all daily tasks on-time with a high level of quality

 

 Leader on U.S. site FDA consent Decree Remediation

 ·         Independent third party - Regulatory Services Group

o   Audit remediation activities against the Consent Decree Workplan, Quality Standards, FDA, cGMPs, applicable laws and regulations.

o   Ensure Remediation Steps comply and meet the Seven Attributes of a Quality System (Process, Procedures, Documentation, Quality Role, Organization, Infrastructure, and Metrics).

o   Review Traceability Matrix to determine which gaps, findings, 483 Observations, and CD requirements are addressed by the Numbered Step.

o   Inspect the facilities to determine if the methods, facilities and controls are operated in conformity with cGMPs, and if maintained, will continuously comply with the FDA, cGMPs, applicable laws and regulations.

o   Categorize findings and develop the respective reports.

 

·         Change Control SME - Interim Controls Group

o   Provide coaching and mentoring to the Change Control Program originators and administrators.

o   Evaluate Change Controls and certify such, if in compliance, prior to quality approval.

o   Evaluated existing Change Control process and support the workshop activities.

o   Provide guidance to Quality System Teams throughout the remediation process.

 

o   Intervet Schering-Plough Animal Health, S.A. de C.V., Santiago de Tianguistenco, Mexico          2009 - 2011

·         Responsible of managing Remediation Project for specific product.

·         Implemented remediation activities for Manufacturing, Validation/Calibration, Quality Control, Quality Assurance, Quality Management and Warehouse areas.

·         Supervised and provided management and technical support to seven (7) Validation Engineers.

·         Scope includes manufacturing batch record review, standard operating procedures, validation activities (Installation, Operational and Performance Qualification) for manufacturing and quality control systems.

·         Provided Technical and Quality support to the organization.

 

o   Glaxo Smith Kline, Cidra, Puerto Rico                                                                                                                  2006 - 2008

Managed and developed Compliance Programs under FDA Oversight, per Consent Decree requirements.  Compliance Programs consisted of:

 o    Regulatory Compliance-Quality Management Team Leader

·            Developed and Implemented Engineering Service Providers Program.

·            Performed audits to certify suppliers and service providers.

o    Quality Standards Professional

·            Developed Periodic Product Review Program.

·            Performed data gathering and analysis of the Manufacturing Batch Records, Analytical and Microbiological Testing, Process Investigations and Costumer Complaints.

o    Product Technology Scientist

·            Developed Product Technology System.

·            Performed Product Technology Area Gap Analysis.

·            Established Remediation Plan and ensured its compliance.

·            Develop SOP’s for the system and delivered  the respective training.

·            Prepared the Product Technology Verification Binder, per Consent Decree requirement.

o    QA1 Remediation Team Coordinator

·            Coordinated 350 SOP’s Translation, Formatting, and Quality Revision.

·            Managed schedule in order to ensure Regulatory Commitment dates were met.

·            Supervised approximately 22 Technical Writers and Translators

·            Developed SOP’s Tracking System.

·            Performed SOP’s Quality Review.

·            Provided support, direction and coaching to subordinate personnel.

·            Ensured compliance with all company policies and procedures, including cGMPs and FDA Regulations.

 

 

o   Lilly del Caribe (PR05), Carolina, Puerto RicO                                                                             2004 - 2005

Commissioning and Validation Project Manager

 

·         Supervised and provided management and technical support to twenty (20) Validation professionals.

·         Managed the implementation, recruiting and management of Quality Requirements/Platform, Quality Assurance Technical and Execution Incident Teams.

·         Lead the coordination of the qualification activities.

·         Prepared project controls, budgeting, scheduling, staffing, weekly and monthly status reports, as required by the client.

·         Responsible for the staffing recruiting process and sub-contractor’s coordination.

 

o   Nypro, Dominican Republic                                                                                                                  2002-2004

Sr. Tech Transfer Director                                                                                                                

  ·         Lead the transfer activities for products from development to manufacturing.

·         Lead multi-functional Operations Transfer Teams to define and complete activities required (create specifications, test methods, manufacturing batch records, validation protocols, and reports as needed) for scale up, validation, transfer to manufacturing, and launching new products.

·         Responsible of PAI submission, post and pre-approval inspection.

·         Performed Supplier evaluation and Certification.

·         Provided regulatory guidance for top-level project development and core teams.

·         Provided support, direction and coaching to subordinate personnel in the areas of hiring, training, disciplinary action, problem resolution, work assignment delegation, and career development.

·         Wrote technical reports in support of production operations and regulatory updates (ANDA, NDA). Investigate manufacturing deviations.

·         Managed all project activities and timelines for the Product Transfer Program within the Technical Services department.

·         Managed $28-million-dollar project budget.

 

o   SCHERING PLOUGH                                                                                                                                         1999-2002

Process Certification Director                                                                                                         

 

·         Developed, implemented and executed regulatory strategic plans for the Pharmaceutical Product Re- Certification under FDA Oversight due to the Consent Decree.

·         Carried out responsibilities in accordance with the organization policies, procedures, and federal, state and local laws.

·          Developed and documented validation project plans / schedules and validation procedures based on sound validation practices and current industry standards.

·         Managed all process validation projects, activities and timelines for the Validation Certification Program within the Technical Services department.

·         Responsible for the generation and execution of process validation protocols, performance qualification protocols per related Standard Operating Procedures (SOP's). Assured the acceptance criteria related to these protocols was met.

·         Reviewed and approved validation / qualification protocols and summary reports completed by the Technical Services department and other departments.

·         Analyzed data, specifications, and basis of design or functional specifications to determine conformance with standards and established quality requirements.

·         Managed all validation personnel (13 regular and 10 consultants) and conducted performance evaluations for exempt direct reports, and assisted direct reports with subordinate performance evaluation process for their areas.

·         Provided support, direction and coaching to subordinate personnel in the areas of hiring, training, disciplinary action, problem resolution, work assignment delegation, and career development.

·         Ensured compliance with all company policies and procedures, including safety rules and regulations.

 

 

o   MDS UNLIMITED CONSULTING SERVICES CORP.                                                                                 1994 - 1999        

Validation & Quality Consultant

 

o  Validation Manager                                                                                                                   

 

·               Supervised, mentored and trained fifteen (15) junior level validation consultants.

·               Responsible of the execution and implementation of projects that supported the manufacturing operation, including projects involving marketed product development, marketed product development, marketed product support and technology transfer.

·               Accountable for the project design and coordination, including development of protocols, design of experiments, data analysis and implementation of optimized manufacturing process and qualification of alternate raw materials, excipients and components.

·               Assessed production problems at component preparation, formulation, filling, sterilization cycle and lyophilization stages by performing investigations, identifying the root causes and developing solutions.

·               Wrote technical reports in support of production operations and regulatory updates (ANDA, NDA). Investigated manufacturing deviations, Experimental and Marketed Stability Failures and Customer Complaints by following a problem solving methodology to comply with the Regulatory Agencies.

 

o  Quality Assurance / Documentation and Change Control Manager                      

 

·               Developed, implemented and maintained standard policies, procedures and controlled document systems, ensuring global level compliance with current good manufacturing practice regulations.

·               Responsible for harmonizing document control procedures throughout the corporation.

·               Participated in companywide projects that heavily impacted existing or proposed controlled documentation and provided facilitation to the project members, to ensure timely completion of these documents.

·               Managed off-site storage and retrieval of controlled documents.

·               Assisted in the development and implementation of document retention policy consistent with corporate policy.

·               Managed the corporate electronic document management system (BEN).

·               Managed all controlled document archives at manufacturing sites.

·               Developed and implemented a program for electronic documentation archiving.

·               Provided mentoring on general Quality Assurance systems/procedures (deviation systems, CAPA, etc.).

·               Gave technical support to Manufacturing Operations in different business units including: Dermik, Aerosols, and Solid Dosage.

·               Evaluated and improved the manufacturing documentation processes. Utilized statistical process control and other tools to assess the performance of the process and implement specific actions to enhance control and achievement of specifications.

 

o  Pharmaceutical Technologist Scientist

·               Wrote technical reports in support of production operations and regulatory updates (ANDA, NDA). Investigated manufacturing deviations, Experimental and Marketed Stability Failures and Customer Complaints by following a problem solving methodology to comply with the Regulatory Agencies.

·               Provided scientific technical support to Manufacturing, and lead the Technology Transfer Process.

·               Acted as a manufacturing technical liaison between Company Headquarters and other sites. Assured that the scale up of products from R&D or products transferred from other sites were accomplished with minimal confusion and disruptions.

·               Wrote, executed and coordinated protocols for process, holding time and cleaning validation. Wrote Working Formula Procedures.

·               Troubleshoot manufacturing problems and provide solutions to day to day incidents and problems. Perform statistical evaluation of process variables. Interpret data, information and regulations.

·               Utilized project management skills to ensure timely and successful completion of assigned projects. Provided training to production personnel in new technologies.

·               Managed all validation personnel (13 regular and 10 consultants) and conducted performance evaluations for exempt direct reports, and assisted direct reports with subordinate performance evaluation process for their areas.

·               Provided support, direction and coaching to subordinate personnel in the areas of hiring, training, disciplinary action, problem resolution, work assignment delegation, and career development.

·               Ensured compliance with all company policies and procedures, including safety rules and regulations.

WARNER LAMBERT, INC                                                                                                                                1988 - 1993

Compliance Coordinator                                                                                                                   

 ·               Audited Manufacturing Areas to assure GMP's Compliance, ISO 9000.

·               Developed the Supplier Certification Program.

·               Developed the Compliance Certification Plan, according to the FDA requirements.

·               Audited and Approved Validation Protocols (IQ, OQ, PQ, Computer and Cleaning Validation).

 Education and Professional Development

 BS, Science Microbiology, Interamerican University of Puerto Rico 

 
 

 

 

 

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