services

Auditing and FDA Readiness

Working with an external resource to support your internal or external auditing needs, FDA readiness or GMP certification readiness comes with many benefits and provides peace of mind.

Internal audits

Internal audits require demonstration of no conflict of interest in that a trained internal auditor cannot audit their own department and in some cases, internal resources do not have the bandwidth to maintain compliance. I can conduct one or more of your internal audits, as needed to support your organization’s internal audit compliance.

External Audits

External audits supporting a supplier qualification program can be cumbersome depending on the number of suppliers, contract manufacturers, and contract service providers. I can provide relief in this arena by travelling for on-site audits or conducting virtual audits against applicable sets of standards and regulations.

FDA Readiness

FDA Readiness audits are beneficial in providing simulations of FDA inspections. Personnel are able to gain confidence in their interactions with government regulators. They are able to improve their skills verbally and gain a clear understanding of timely request deliverance, responses, tracking and corrections.

GMP Certification Inspection Readiness

Preparing for an upcoming independent standard GMP inspection in advance is crucial to accomplishing a GMP certification or registration to improve your company’s reputation and marketability. Once you have a standard to certify against, an inspection readiness gap assessment can be conducted to support your successful certification.

Processes and Procedures

Whether you are looking to establish new processes and procedures or revise and optimize existing processes and procedures, it is important to ensure they are tailored to your organization’s needs.

New Processes, Programs and Procedures

Instituting new processes, programs, and procedures can be daunting. For example, you may need to establish new environmental monitoring programs, training program, investigation processes, or recall procedures. I can support you in the event you may need consultation, an additional external resource to support your team, or a second opinion.

Existing Processes, programs, and Procedures

Revision and optimization of procedures is required in various stages of your organization’s operations. You may be seeking to simplify a process or procedure to fit your organization size and quality maturity. You may be in progress with changes such as scaling a manufacturing process which may impact one or more processes, programs, or controlled documents. Years may have passed since effective procedures have been reviewed for content and current applicability. You may have had an FDA-483 or customer inspection finding requiring remediation affecting your processes, programs, or procedures. An external resource can review and handle heavy lifting of revisions and optimizations in conjunction with feedback and involvement from your stakeholders.

Training

Approachable training and guidance can be tailored to the needs of your organization. Topics and focus will be based on your organization’s industry.

Training

Learning new skills or refreshing and reenforcing existing skills is vital to ensure your workforce stays sharp. A solid training program can benefit from support from an external resource.

Training opportunities may be specific to current good manufacturing practices (cGMP) training for your drug, dietary supplement, food, or industrial hemp cannabinoid company. Content and duration options are dependent on your organization’s needs.

Training may be more detailed and focused if your organization needs to build knowledge in certain areas such as, supplier qualification, stability, or root cause analysis.

Training can be delivered on a 1:1 basis, small groups, or larger groups of your organization.

Initial and refresher GMP training is not only a regulatory requirement, but it can positively impact your organization.

  • Your company’s cost of quality can be lowered when compliance is achieved.

  • Employee engagement and morale can be increased when personnel feel empowered and own programs.

  • Your reputation as a quality minded company is valuable to customers, consumers, and regulatory agencies.

Quality Management Systems

A QMS must work for your organization’s industry, size, and maturity level while supporting customer satisfaction and retention.

Quality Management System (QMS)

Your organization’s QMS must maintain and seek continuous improvement of quality management, products, and services to achieve true customer satisfaction and support your business needs.

While often similar, different industries’ QMS’s have some unique requirements. The most functional QMS requires commitment and inclusion of all organization members.

I can support your organization with any of the following QMS needs:

  • You require assistance in the beginning phases of conceptualizing, building and implementing a QMS.

  • You have or are in progress of revising your QMS to support additional product types or customer demands.

  • Your company strategies or resources have changed requiring revisions to your QMS.