By Maureen Martino www.raps.org

“FDA Patient Safety News,” the FDA’s monthly video series for health care professionals, has won the Cheers Award from the Institute for Safe Medication Practices (ISMP) for efforts to improve the safe use of medical products and prevent medical errors.

The ISMP Cheers Awards honors organizations that have set a superior standard of excellence for others to follow in the prevention of medication errors and adverse drug events.

“FDA Patient Safety News” is broadcast monthly over several medical satellite television networks to more than 4,500 U.S. hospitals and long-term care facilities. It conveys safety information about drugs, devices and vaccines directly from the FDA to physicians, pharmacists, nurses, risk managers and educators across the country; reports on recalls and safety alerts and medical errors; and provides tips on how to protect patients.

The program’s video format makes possible the demonstration of patient protection techniques; showing of recalled and counterfeit products; illustrating how medical errors occur; and demonstrating how to reduce risks when using medical products.

In addition to the monthly satellite broadcasts, a link to the show is distributed by e-mail every month to approximately 170,000 subscribers. The program also has its own Web page, http://www.fda.gov/psn, where viewers can download the videos or watch them online, read or print the story scripts, or subscribe to receive the program via video podcasting or RSS feed—all free of charge.

“FDA Patient Safety News” is intended primarily for a professional audience. However, on the assumption that health care professionals will discuss these topics with their patients, some of the videos include information for patients or consumers.

Twenty year veteran with a wide scope of experience. Excellent skill set in Quality Systems, technical writing and Audits for the Pharmaceutical and Medical Device industry.

Senior Consultant; Plant Manager; Pilot Plant/ Process Manager; Clinical Trials / Manufacturing Specialist; Technology Transfer Specialist

• Has created a holistic Quality system (event notification, investigation, CAPA, change control, documentation and training) that fulfilled regional and national requirements
• Qualified in writing technical documents (SOP, Master Batch Record, policy, investigation report); skilled in electronic document management
• Experienced in Business process design and management using lean Six Sigma models and operational excellence
• Expert in preparing organization for Pre-Approval Inspections (PAI), due diligence, compliance and for cause audits; has hosted many FDA inspections and contributed to 483 responses
• Extensive knowledge in creating and delivering training presentations; creating and administering pre- and post-training assessments 

Forty-five years experience in program management, quality system assessments, development and integration of complex systems of large scale real-time military and civil systems. Trained in the Canadian Medical Devices Conformity Assessment System (CMDCAS).

Senior Consultant; Program Manager; Lead Instructor; ISO Management Representative

• Certified Quality Management Systems Auditor by Registrar Accreditation Board; certified to conduct ISO audits
• Lockheed Martin Certified Federal Program Management Professional
• Strong training skills; lead instructor and course owner for a suite of six Quality Assurance courses
• Experienced with Program Management and maintenance of ISO Registration and Re-Registrations with SGS
• Fluent in German  

Biotechnology and Pharmaceutical expert with eighteen years experience. Strong validation, commissioning, and Documentation skills.Sr. Validation Specialist; Validation Specialist; Calibrations Group Supervisor; Instrumentation and Controls & Sr. Applications Engineer; Facilities Supervisor/Systems Engineer

• Subject matter expert and issues resolution resource for Distributed Controls (DCS/BMS), HVAC/R, Dehumidification, Air Flow and Pressurization, Tablet Coating, and USP (RO) Water Purification and Filtration systems and projects
• Experienced in implementation, startup, and commissioning of control systems for tablet coating and associated dust collection process equipment
• Well versed in site audits and PAI preparations
• Skilled at documentation development and implementation for utilities and facilities’ critical process support systems associated with the Sterile Facilities Projects
• Excellent IQ/OQ/PQ validation skills

Pharmaceutical veteran with thirty five years experience in Quality Assurance, Quality Systems and GMP Compliance. Experienced with Large, multi-national pharmaceutical companies.

Senior Manager, Quality Improvement & Planning; Director, US Documentation Systems; Manager, US QA Labeling; Business Development Specialist

• Extremely comfortable with all Batch certification functions; assisted three major pharmaceutical companies under Consent Decree, performed batch certification functions for release of product
• Experienced with assessment, design, development and implementation of Quality Systems and coaching clients in these functions
• Skilled in interpretation and application of GMP requirements for compliance
• Knowledgeable in Solid dosage forms, ointments, creams, liquids, sterile products, and vaccines
• Experienced with designing and implementing corporate wide documentation and change control systems

Twenty five year expert with expertise in global manufacturing, quality assurance, regulatory affairs, marketing and new business development. Industries include: pharmaceuticals, nutritional supplements, dosage forms and bulk, medical devices, diagnostic products and cosmetics.

Senior Vice President of Quality; Corporate Vice President General Manger and Technical Affairs; Director, Technical Services; Plant Manager/Director of Manufacturing; Director of Regulatory Affairs

• Experienced in worldwide GMP regulations, plant inspections, product registrations, supplier and customer audits and relations
• Direct global dealings with regulatory agencies, ie, FDA; DEA; NRC; State Departments of Health; UK MCA; Health Canada; health authorities in Mexico, the Netherlands and India; sFDA in China
• Has developed standard corporate quality assurance and compliance programs as part of an overall quality system to include GMP, validation, personnel training, auditing, technology and site transfers, SOPs
• Expert with pharmaceutical products Rx and OTC, innovator brand name and generic
• Strong skills in Biological products and Sterile product manufacturing

Quality Assurance Manager; Quality Assurance/Regulatory Affairs Manager; Supplier Quality Auditor; Senior Quality Engineer; Supplier Quality Engineer

• Extremely versed in internal and external audits: perform supplier audits based on the QSR and/or ISO13485, write audit plans and report
• Experienced in 510(K) submission work
• Supported both manufacturing and product development in multi-functional team environments
• Strong working knowledge of Statistical Process Control; GMP Regulations ; ISO Standards; Design Controls; Risk Analysis and Management; Project and Supplier Management
• Certified Quality Engineer and Auditor through ASQ

Twenty-eight year veteran with experience in the Medical Device, Pharmaceutical and Biomedical industries.   Strong domestic and international capabilities in managing operations, engineering, manufacturing, and quality systems teams.

Senior Quality Systems Project Manager, Global Regulatory Compliance & Management; Manager, Pilot Plant Operations; Senior Manager, Manufacturing; Senior Supervisor, Quality Engineering Supplier Development

·    Expert in manufacturing and quality management systems with extensive experience with start up companies

·    Possesses exceptional validation experience with processes, equipment, software, and methods

·    Strong in product development, design control and product transfers

·    Experienced with the following products: Insulin pumps and I.V. pumps; vaccines, injectables; Diagnostic tests and instruments

·    Regulatory expertise in: ICH, Japan, and EU

 

Senior Consultant and Lead with over twelve years of diversified experience in project/process engineering, software quality assurance and testing, and validation project management.  Has worked extensively within the medical device, pharmaceutical, chemical and food industries. 

 

Titles Held: Senior Consultant; Validation Team Lead; Senior QA/QC Engineer; Senior Validation Engineer

 

• Results oriented professional, particularly effective in validation project management, remediation compliance and documentation; demonstrated expertise in performing Gap analyses/audits with respect to current industrial standards 
• Demonstrated expertise in handling complete validation project cycle including creation of DQ/IQ/OQ/PQ protocols testing procedures and SOPs 
• Practical knowledge and experience of drug development, compliance and regulatory guidance’s (ICH and FDA), cGMPs, and ISO quality systems standards 
• Experience with deviation tracking software such as TrackWise, analytical software (e.g. SQL*LIMS and LabWare LIMS) and pharmaceutical process automation MES, MRP and GLP information systems 
• Experience preparing and ensuring the timely completion of well-organized, scientifically sound regulatory submissions, to include DMFs, INDs, CTXs, NDAs, BLAs, IDEs, PMAs, etc. and required amendments