Connecting You with Solutions
Dedicated to your success!
Connecting You with Solutions
Dedicated to your success!
PHARMACEUTICAL CONSULTING Services
Environmental Health and Safety and Emergency Management
Environmental Health and Safety and Emergency Management
Environmental Health and Safety and Emergency Management
- CFR Compliance
- Site Inspection and Risk Analysis Evaluation
- Full Risk Assessment Reporting
- Procedural Implementation and Training
Project Management
Environmental Health and Safety and Emergency Management
Environmental Health and Safety and Emergency Management
- Medical Device and Pharmaceutical Project Life Cycle
- Quality Results in a Timely Manner
- Ensure Teams Operate Cohesively Using Leadership, Organization, and Task Prioritization
Cooperate Leadership
Environmental Health and Safety and Emergency Management
Cooperate Leadership
- Drug Development
- Management of Teams
- Coordination Between Venders, Suppliers, and Clients
- Manufacturing
Environmental Health and Safety and Emergency Management
Our Specialist's Qualifications
Diverse Life Safety and Emergency Management Specialist looking to improve the overall safety atmosphere through years of collected experience in code enforcement, emergency action planning and crisis management. Unique and modern approach to safety compliance and contingency planning. Developing, implementing, and training on safety programs. Certified in OSHA, ANSI, DOT, EPA, GHS, FEMA, and NFPA regulations. Experienced Crisis Management Team Lead and Risk Analysis Coordinator. Experienced Life Safety and Emergency Management site inspector/surveyor. Employment affiliations include the Department of Defense, Homeland Security, Federal Emergency Management Agency, The Joint Commission, The Centers for Medicare and Medicaid, Pennsylvania Department of Health, and The Food and Drug Administration. Honorable military veteran with credentials as a Fire Marshal/Duty Officer, Safety Supervisor and Training Coordinator at the Presidential Retreat Camp David for two administrations under the White House Chief of Staff. Purple Heart Recipient
Our Specialist's Concerns
“Workplace safety isn't just a nice idea; it's a legal requirement. The Occupational Safety and Health Act requires that employers take safety precautions to prevent on-the-job injuries and accidents. It applies to every employer, the Occupational Safety and Health Agency, oversees OSH Act enforcement”.
The average cost for a single manufacturing safety hazard citation issued by OSHA sets a company back by $13,494. The overall costs contributed to a single manufactory safety issue does not end with the written citation, OSHA will administer a time frame of corrective actions which can cost an unforeseen dollar amount. If the deadline set forth is not met an additional penalty fine will be added to the overall cost for every day the corrective action is addressed. If OSHA makes the determination that the safety violation was committed willfully and or is a repeated violation the initial fine can average around $134,937 per citation. In accordance with the Information Sharing provisions under Section IV, other federal agencies are permeant to violations if it is pertinent to their agencies regulatory standards and additional citations can arise from “for cause” audits or inspections.
Excite Consulting’s mission is to provide an ongoing comprehensive and methodical approach in your businesses’ prevention and preparedness of health and safety in the workforce. Utilizing the expertise of our team of professionals we aim to provide a pivotal role in the training, consulting, planning, development, and implementation of safety programs and emergency management. Our teams’ years of experience and vast knowledge base of regulatory compliance to safety standards and guidelines will ensure your business meets all requirements set forth by local, state, and federal entities. We strive to ensure the best possible service by committing to innovative and progressive approaches to risk management and safety compliance reducing costs in workplace mishaps, emergencies, and potential regulatory citations.
“Preventing accidents and injuries requires more than occasional safety tips. Maintaining a safe workplace requires education and training.”
Our highly trained Consultants will start by conducting a site assessment survey or vulnerability hazard assessment to develop an overall risk analysis summery based on the accumulative data collected in an “all hazards” approach. Our consultants will review current documentation of existing company safety related policies and emergency action plans as set forth by state and federal agencies and assess the overall competency based on current standards. Our consultants will support your business by providing technical and professional feedback to assist in the editing or development of emergency action plans or high priority safety concerns. Our consultants will generate a summary report defining all safety related concerns and notate the regulating body by code or standard. In addition, the summery report will identify and prioritize safety concerns and support corrective actions. In the event your business requires safety policies generated our highly efficient staff are prepared to write, train, and support implementing safety standards in coordination with your dedicated safety staff.
“The FDA and OSHA will share relevant information with each other, while ensuring that the exchange of such information complies with applicable law. The consequences of not following OSHA regulations or violating them come with civil penalties of $70,000 for every violation that is found during an inspection. Civil penalties are stated in 29 CFR 1903.15 and assessed at the time of inspection.”
Our Specialist's Publications
1. The Life Safety Code Field Guide for Healthcare Facilities
2. The Life Safety Code Workbook and Study Guide for Healthcare Facilities
3. The Security Field Guide for Healthcare Facilities
4. The Notable points for Healthcare Facilities
PROJECT Management
Our Specialist's Qualifications
- Over 25 years of experience
- Project Management, Leadership, Cross-Functional Teamwork, Strategic Planning, Analytical Thinking, Problem Solving, Communication, Goal Setting, Time Management, Organization, Multitasking, Prioritization, Creativity
Our Specialist's Skills
- Capable of delivering quality results in a timely manner
- Maintains a pulse on trends and best practices to keep projects innovative in nature
- Ensures teams operate cohesively using leadership, organization and task prioritization acumen
- Manager of numerous successful projects, handling work independently and solving routine concerns with minimal supervision
- Adept at quickly learning new processes
- Confident team player with an aptitude for excelling in regulated environments
- Willing to travel to sites for consulting engagements
Our Specialist's Experience
- Complex medical device / drug device combination / drug development
- Lead complex Regulatory Affairs projects to achieve compliance with Conversion to Medical Device Single Audit Program (MDSAP) and In Vitro Diagnostic Regulations (IVDR)
- To launch products, formulated project plans featuring objectives and timelines used to implement and launch product
- Produced complex project schedules using tasks featuring dependencies and critical paths
- Wrote and delivered weekly project status reports to keep relevant stakeholders informed; also developed action plans to present monthly to the Senior Leadership Teams
- Adhered to project deadlines and milestones across numerous efforts at once
- Collaboratively defined project scope, goals, milestones, deliverables, tasks and resource requirements from concept creation through implementation across multiple products
- Exceled in teams to identify and create risk management plans featuring risk triggers and mitigation tactics
- Liaise between project team members and consultants to maintain clear lines of communications
- Successfully defend medical device Design History Files during internal and external audits
- Devised comprehensive, articulate documents including business correspondence and technical reports
- Created and maintained processes for leading the quality development of medical devices / drug device combination in a regulated setting
- Devised documents for regulatory submissions, e.g., Case Report Forms (CRFs), Protocols, Informed Consents, etc. for clinical trials
- Aimed to secure drug approval and project support per Food and Drug Administration (FDA) and International Committee for Harmonization (ICH) guidelines
- Synchronized operations with Clinical Monitors and Project Managers to supply accurate data to the FDA and other regulatory agencies for project support/submissions
- Founded and monitored clinical trial sites, contacting primary clinical investigators and tracking clinical trial data
- Precisely shipped test articles to clinical trial sites
- Authored project status update reports for sponsor review
- Prepared submissions for Investigational New Animal Drugs (INADs), New Animal Drug Applications (NADAs), and Veterinary Master Files (VMFs) for the Center for Veterinary Medicine (CVM) Branch of the Food and Drug Administration (FDA)
- Sought to garner timely drug approval and project support
- Prepared and submitted package inserts and label updates to the FDA/CVM
- Efficiently tracked animals on clinical trials according to FDA/CVM authorization