B&R Compliance Associates

Understand compliance gaps and site hazards, and get expert recommendations to improve performance and strengthen safety.

Prepare for audits and inspections and pursue voluntary certifications with expert support that helps protect customer relationships and identify improvements.

Get expert FDA and regulatory guidance to strengthen compliance, manage food safety risks, and improve food, beverage, and medical business operations.

Helps companies understand DOT requirements, keep employees safe and compliant, and manage driver records and required training without a full-time DOT compliance manager.

Optimize operations, reduce costs, improve quality, and support lasting operational and compliance improvements.

Navigate environmental requirements, manage environmental risks, and advance sustainability goals with tailored consulting, compliance support, and emissions reporting.

Build gas-handling expertise, prepare for relevant certifications, and support compliant installations and gas operations.

Get expert help to resolve incidents, navigate regulatory investigations, limit crisis impact, and reduce future risk.

Deliver flexible, tailored training and track employee records to help maintain compliance and audit readiness.

Helps businesses support FDA compliance and reduce risks of product defects, contamination, and safety issues through tailored process and system validations.

Build a safer, OSHA-compliant workplace while protecting employees, reducing costs, and supporting a positive company reputation.

Assessments

B&R Compliance Associates conducts comprehensive assessments informed by industry safety standards, regulations, and best practices, including FDA, DOT, and OSHA requirements. Services include voluntary gap assessments comparing current practices with regulatory requirements or industry best practices; HAZID, HAZOP, HACCP, and other risk assessments; and third-party reviews when required by a regulatory body or other authority. Assessments examine process interactions and efficiency, identify compliance gaps, hazards, and business improvement opportunities, and provide reports or mitigation recommendations to help organizations improve performance and protect employees, products, customers, and the business.

Category: Compliance Consulting Services

• Identify Gaps And Improvement Opportunities
  Get a detailed view of compliance gaps and potential business improvements, supported by an assessment of current practices, process interactions, and efficiency.
• Identify Site Hazards
  Understand hazards at your site and support risk reduction and safety for employees, products, and customers.
• Mitigate Risks And Protect Your Business
  Receive recommendations for addressing hazards and reducing risks to employees and the business.
• Meet Outside Review Requirements
  Get support from an external assessment provider when a regulatory body or other authority requires an outside review.

Audit and Certification Support

B&R Compliance Associates helps businesses prepare for audits and inspections and pursue voluntary standard certifications. Support includes certification preparation for standards such as ISO, Kosher, NSF, and GFSI-benchmarked schemes; assistance with customer audits of sites or processes; and preparation for regulatory inspections. Preparation can include mock inspections or audits and remote inspections that simulate a regulatory inspection, followed by a detailed report of deficiencies and improvement recommendations.

• Pursue Voluntary Certifications
  Get support while pursuing voluntary standards such as ISO, Kosher, NSF, or a GFSI-benchmarked scheme to expand your market or meet customer requirements.
• Prepare For Regulatory Inspections
  Prepare for unannounced regulatory inspections with expert support to help your business be ready when regulatory bodies arrive.
• Prepare For Customer Audits
  Get help preparing for customer audits of your site or processes, with support intended to help the audit go smoothly and protect business relationships.
• Identify Deficiencies And Improvements
  Receive a detailed report outlining deficiencies and recommendations for improvement after inspection support.
• Simulate Regulatory Inspections
  Use mock inspections or audits to experience the feel of a regulatory inspection as part of preparation.
• Practice Remote Inspections
  Include remote inspections in preparation to experience the feel of a regulatory inspection.

Beverage, Food, and Medical Support

B&R Compliance Associates provides FDA and regulatory consulting for food, beverage, drug, biologics, and medical device businesses. Support includes interpreting regulations, managing FDA interactions and adverse events, providing federal registration and listing services, delivering cGMP training, and developing and improving food safety and quality systems. The service also includes food safety risk assessments and support for food and beverage gas applications.

• Improve Food Safety Systems
  Develop, implement, maintain, and improve food safety and quality systems, including food safety plans, with consulting and training support.
• Manage FDA Interactions
  Address enforcement actions with guidance to repair compliance programs and manage FDA interactions more effectively.
• Assess Hazards And Develop Controls
  Identify potential facility and product hazards and develop risk-based controls through HACCP or HARPC programs.
• Interpret FDA Requirements
  Get expert support interpreting FDA requirements and applying them to business operations.
• Manage Recalls And Reports
  Get help managing recall processes, preparing effectiveness reports, submitting MedWatch reports, and handling related FDA compliance actions.
• Complete FDA Registrations
  Access establishment registration and product listing services for applicable regulated businesses, along with registration services for food and beverage facilities.
• Train Teams On cGMP
  Prepare personnel for cGMP requirements across sanitation, facilities, equipment, operations, quality management, and process controls.
• Strengthen Gas Compliance
  Get compliance and regulatory guidance for food and beverage gas applications, including safety and GMP program development, capability reviews, and support for existing programs.

DOT Compliance

B&R Compliance Associates provides DOT regulatory guidance and compliance support to help companies understand the requirements that apply to their operations and keep employees safe and compliant without hiring a full-time DOT compliance manager. Services include an online driver qualification file system, access to driver screening and motor vehicle reports, automated expiration reminders, and self-paced online training for hazardous materials employees and managers or supervisors of drivers.

• Clarify Applicable DOT Requirements
  Get guidance on the DOT regulatory responsibilities and requirements that apply to your operations, along with support to help keep employees safe and compliant.
• Manage Driver Files Online
  Use an online system to maintain electronic driver qualification files and support compliance with DOT driver file qualification regulations.
• Track Document Expirations
  Receive automated reminders for driver license and medical card expirations, helping staff monitor important dates.
• Train Hazmat Employees Online
  Provide hazmat employees with self-paced online training for required HMR training, without coordinating an all-day, in-person meeting.
• Train Driver Supervisors Online
  Help designated driver supervisors complete alcohol and drug reasonable suspicion training through a self-paced online course.
• Access Driver Reports
  Access DOT Pre-Employment Screening Program reports and State Motor Vehicle Reports through the online driver qualification file system.

Efficiency and Productivity

B&R Compliance Associates provides operational consulting to help businesses optimize operations, reduce costs, improve quality, and support a more productive and innovative work environment. Services include developing and prioritizing plans to close gaps identified through inspections or assessments, reviewing ASU and CO2 plants and cylinder operations for efficiency, guiding rail supply and logistics decisions, and creating procedures, manuals, and other technical documentation. Ongoing support can help maintain operational and compliance improvements.

Category: Business Process Improvement Consulting

• Prioritize And Maintain Improvements
  Get a practical roadmap for addressing inspection or assessment findings, with ongoing support to help maintain improvements and progress toward operational and compliance goals.
• Improve Process Effectiveness And Efficiency
  Review ASU plants, CO2 plants, and cylinder operations to identify opportunities to make these operations more effective and efficient.
• Optimize Business Operations
  Use B&R's operational expertise to improve how the business operates, with the potential for long-lasting positive impacts on performance and competitiveness.
• Reduce Business Costs
  Pursue lower costs through operational improvement and guidance on rail operations when evaluating options to reduce costs.
• Improve Business Quality
  Apply operational expertise to support improvements in business quality.
• Evaluate Rail Supply Options
  Receive guidance through the decision process for railroad operations when considering cost reduction or security of supply.
• Create Clear Technical Documentation
  Obtain professionally prepared technical documentation, such as procedures and manuals, to support business needs.
• Foster Workplace Productivity
  Support a more productive work environment as part of broader operational improvement.
• Foster Workplace Innovation
  Support a more innovative work environment as part of the service's broader operational aims.

Environmental Compliance

B&R Compliance Associates provides environmental regulatory interpretation and compliance consulting, including support for RCRA, CERCLA, SARA, the Clean Water Act, stormwater management, permitting, and EPA reporting. Services include Phase I and Phase II Environmental Site Assessments for investment and divestment due diligence; development of EPA Risk Management Plans; development and execution of Environmental Management Systems for ISO 14001 or Responsible Care certification; and technical oversight and portfolio management for remediation projects. B&R also supports greenhouse gas evaluation, analysis, and management, including emissions measurement, reporting, and verification to help clients meet sustainability metrics and obtain carbon credits.

• Navigate Environmental Regulations
  Get guidance interpreting environmental requirements and support for compliance programs, including applicable federal regulations, EPA reporting, stormwater management, and industry standards.
• Identify And Mitigate Environmental Risks
  Identify potential environmental risks and receive recommendations for measures to mitigate negative environmental impacts and help protect company reputation.
• Develop EPA Risk Management Plans
  Receive support developing a Risk Management Plan for a facility housing extremely hazardous substances, helping address EPA requirements and site safety.
• Develop Certification-Ready Systems
  Develop and execute an Environmental Management System to support a company's pursuit of ISO 14001 or Responsible Care certification.
• Manage Complex Remediation Projects
  Get technical oversight and portfolio management for remediation, including complex soil and groundwater programs and state, federal, and National Priorities List cleanup sites.
• Measure And Verify Emissions
  Collect, measure, report, and verify greenhouse gas emissions to support sustainability metrics and carbon credit goals.
• Support Environmental Permitting
  Access consulting support for environmental permitting as part of managing environmental affairs and regulatory responsibilities.
• Assess Sites For Due Diligence
  Get support with Phase I and Phase II Environmental Site Assessments to inform due diligence for investment and divestment.
• Advance Environmental Goals
  Get guidance navigating ESG efforts and environmental affairs, integrating eco-friendly operations, and working toward environmental goals.
• Build Sustainability Awareness
  Use training delivered through B&R's Learning Management System to raise awareness about sustainability and environmental issues.

Gases Training and Support

B&R Compliance Associates provides industrial gas business support, training, and compliance programs. Services include bulk gas installation training for technicians and end users; healthcare installation training for cryogenic fluid central supply systems; preparation for CGA M-1, ASSE 6015, and ASSE 6035 certifications; food and beverage gas programs; and an FDA-recognized medical gas compliance program. Healthcare installation support includes procedures, forms, technical information, ASME brazing certification, and ongoing regulatory, engineering, maintenance, and process consulting.

• Support Compliant Healthcare Installations
  Give technicians structured installation procedures, training, forms, and technical information for healthcare central supply systems, with documentation of relevant training.
• Train Technicians And End Users
  Prepare installation technicians with bulk gas system installation knowledge and best practices, and train end users in safe gas and system handling.
• Prepare For Installer Certification
  Help healthcare facility installers prepare for CGA M-1 and ASSE 6015 certification with instruction on requirements, system design and installation, documentation, and commissioning.
• Support FDA-Recognized Medical Gas Compliance
  Apply an integrated program covering medical gases, their operating modes, and industry-specific procedures.
• Access Ongoing Expert Support
  Get continuing regulatory, engineering, maintenance, and process guidance for healthcare bulk gas systems.
• Prepare For Verifier Certification
  Prepare healthcare system verifiers for the ASSE 6035 exam with seminars covering system design, documentation, testing, and relevant requirements, codes, and standards.
• Support Food And Beverage Gas Operations
  Use an industry-specific program for cylinder fill and mini-bulk operations, with coverage of food and beverage gases, operating modes, and FDA-compliant food safety plans.
• Obtain ASME Brazing Certification
  Access ASME brazing certification through a qualified Certified Welding Inspector as part of the healthcare installation program.

Incident Investigation and Support

B&R provides immediate expert support for incidents such as food safety or quality events. The team works with your staff to address issues at their source, assist with regulatory investigations, solve problems, minimize the impact of a crisis, and provide guidance to mitigate future risk.

• Get Immediate Expert Incident Support
  Access expert attention for incidents that require an immediate response, including food safety and quality events.
• Minimize Crisis Impact
  Get support aimed at minimizing the impact a crisis has on your business.
• Address Issues At Their Source
  Work to address the source of an incident, supporting efforts to resolve the underlying issues at the facility.
• Navigate Regulatory Investigations
  Receive assistance with regulatory investigations arising in connection with an incident.
• Solve Problems With Your Team
  Collaborate with B&R to solve incident-related problems with your team.
• Mitigate Future Risk
  Receive guidance to help mitigate future risk after addressing an incident.

Learning Management and Training

B&R provides custom training programs and materials, instructional design, and its web-based, mobile-friendly B&R Learning LMS. The system offers on-demand eLearning, training records, certification documents, and recertification reminders to help companies stay compliant and audit-ready. Training can cover DOT, HazMat, OSHA, FDA compliance, industrial gas work, company policies, onboarding, career development, and other needs. Businesses can use existing courses, provide their own content for hosting, or request custom content. B&R also provides industrial gas bulk installation training from experienced technical experts.

• Access Training Across Devices
  Employees can access on-demand learning through a web-based system designed to work on mobile devices.
• Access Essential Training Topics
  Address regulatory compliance and job-specific learning through on-demand courses, including DOT, HazMat, OSHA, FDA compliance, industrial gases, and bulk gas installations.
• Maintain Audit-Ready Training Records
  Keep training records and certification documents available to support compliance activities and audit preparation.
• Tailor Learning To Your Needs
  Choose existing courses, host company content, or request custom materials. Training can include policies, onboarding, career development, fraud awareness, and other organizational topics.
• Train Installation Technicians
  Industrial gas technicians and installers can receive training from experienced technical experts to support certification by B&R Compliance Associates and applicable regulatory requirements.
• Track Recertification Requirements
  Use reminders to stay aware of recertification needs and support continued training compliance.

Process System Validations

B&R Compliance Associates develops and executes validation and system qualification protocols for analytical methods and equipment, automated plants, gas-related cleaning processes, computer-controlled equipment, cylinder filling systems, and electronic recordkeeping and signature systems. Its support helps businesses address FDA requirements and establish that systems and processes meet applicable validation needs. Services include adaptable cylinder-fill protocol templates and guidance on documentation from system manufacturers.

• Validate Automated Medical Product Plants
  FDA-compliant protocols support validation of automated plants producing medical products, including air separation, helium, and medical-grade carbon dioxide facilities.
• Validate Filling Systems And Adapt Protocols
  Validation services cover manual and automated high-pressure and cryogenic liquid filling systems. Adaptable templates and guidance on manufacturer documentation support businesses preparing for a new fill system or validating an existing one.
• Reduce Product And Process Risks
  Validations help minimize risks of product defects, contamination, and safety issues, supporting consistent production of high-quality and safe products.
• Establish Method And Equipment Equivalence
  Validation protocols help establish that analytical methodologies and equipment are equal or superior to USP/NF compendia methods.
• Validate Computer-Controlled Equipment
  Validation support addresses FDA requirements for computer-controlled or operated manufacturing and analytical equipment.
• Validate Electronic FDA Record Systems
  Guidance supports validation of electronic recordkeeping and signature systems used to maintain FDA records, including systems commonly used in the medical gases industry.
• Validate Gas-Related Cleaning Processes
  Designed and executed programs and procedures help firms validate cleaning processes related to gases.

Safety

B&R Compliance Associates provides safety consulting and support to help businesses navigate applicable OSHA regulations and standards. Services include safety assessments, incident investigations, and training. The company also assists firms in developing and implementing programs to meet OSHA Process Safety Management and EPA Risk Management requirements.

• Navigate OSHA Requirements
  Get help understanding applicable OSHA regulations and standards and working toward compliance.
• Develop Process Safety Programs
  Get experienced assistance developing and implementing programs to meet OSHA Process Safety Management requirements.
• Meet EPA Risk Requirements
  Get experienced assistance developing and implementing programs to meet EPA Risk Management requirements.
• Assess Workplace Safety
  Access an assessment to support your company's OSHA compliance and general safety efforts.
• Investigate Safety Incidents
  Get expert support with incident investigations as part of your company's safety and compliance work.
• Train For Safer Work
  Access training as part of your efforts to comply with applicable OSHA standards and support workplace safety.