Review and audit programs

Audit Programs and Services

	Site Audits - The professionals at B&R have over 50 years of combined FDA inspection experience. When we visit your site our compliance assessments are conducted as mock FDA inspections. This type of audit format provides both a full assessment of cGMP program compliance and valuable training for your operations staff in handling an actual FDA audit. Our audit protocols and techniques incorporate current FDA audit procedures and focus, as well as emerging medical gas enforcement activity and trends. Corrective and Preventative Actions (CAPA) - In addition to providing you with a detailed audit report we assist your management team to develop a CAPA plan as a road map towards achieving your operations and compliance goals.
	Audit Subscription Program - The B&R Audit Program provides the tools and support you need to effectively conduct self-audits of your production facilities. Each package includes a self-scoring audit checklist, an auditor guide & instructions, and report forms. Automatic Updates - B&R provides automatic updates to all audit materials as FDA requirements change or new compliance trends emerge. Professional Review and Advice - Subscribers have the option to send their completed self-assessments to B&R for a professional auditor review and suggestions on developing corrective and preventative actions.
	Competency Verification Program - The quality and safety of the medical gases leaving your facility are directly linked to the competency of your fill room staff. To verify your employees full understanding of their tasks and associated cGMP requirements we send a B&R compliance expert who conducts detailed task observations of your fill room employees while they perform their jobs at their workstations. Assuring Process Integrity - The B&R Competency Verification program can help you move your organization to the next level and help you assure the effectiveness and integrity of your medical operations and products.

B&R can provide a wide range of audit services that include auditor training, audit program review, audit protocol development, compliance program gap assessments, and corrective and preventative action plan development. Contact us to learn more about putting our Total Solution for auditing to work for your business.