Florestal Consulting & Associates (FCA) is a full-service GMP and quality systems consultancy that provides comprehensive quality, regulatory and compliance strategies to the pharmaceutical, biotech and medical device industries. We specialize in helping companies conduct effective root-cause investigations and implement effective strategies for corrective and preventive actions (CAPA).
FDA compliance consulting services
We provide our clients with exceptional consulting services rooted in compliance to applicable FDA regulations and regulatory standards. Our expert consultants are well-credentialed and highly experienced in the pharmaceutical, biotechnology and medical device industries and will help implement effective strategies for the remediation of FDA-483s, warning letters and consent decree citations.
cGMP and quality systems training programs
Our cGMP and quality systems training programs are tailored to meet not only FDA requirements but also individual organizational needs. We work with each organization to ensure compliance strategies are identified and provide meaningful approaches for implementation.
Our strategies include:
- Investigating non-conformities and identifying root causes relating to product, processes and / or the quality system
- Identifying the actions necessary to correct and prevent recurrence of non-conforming product and other quality problems
- Verifying the corrective and preventive actions for effectivity
- Evaluating procedures / processes which establish a high degree of assurance that the manufacturing process was effective and could consistently produce a product meeting its predetermined specifications and quality attributes
- Implementing needs-based training to address gaps and deficiencies in the organization’s quality system or GMP requirements
The successful implementation of these strategies results in a reduction of the high cost of non-compliance; significant cost savings in manufacturing / production processes; maintenance of a company’s competitive edge; and the conduction of effective quality system investigations that implement effective strategies for right-first-time (RFT).
cGMP compliance training services
At FCA, our commitment to the pharmaceutical, biotech and medical device industries extends beyond root cause investigations. Training is an integral part of any FDA-regulated environment and, as such, our training program helps to establish the proper foundation for not only meeting FDA requirements but also ensuring that effective strategies have been implemented for sustainable compliance.
cGMPs 21 CFR Parts 210 and 211 compliance training program
We have developed a comprehensive training program entitled ‘Complying with cGMPs 21 CFR Parts 210 and 211’. This two-day course provides the essential tools necessary to overcome common challenges for cGMPs, determine cGMP requirements and evaluate common FDA trigger points.
Non-conformance investigations and CAPA implementation
FCA consultants work extensively with individuals to ensure that product, process and / or quality system non-conformances are appropriately investigated, root causes are identified and effective CAPAs are implemented. We verify that CAPA system procedures addressing the requirements of the quality system regulation are defined and well documented.
Additionally, our consultants strive to ensure that actions needed to correct and prevent recurrence of nonconforming product and other quality problems are identified. Our consultants evaluate and / or confirm that the controls in place for preventing distribution of nonconforming products are in fact implemented and effective.
Quality system and cGMP management
Medical device manufacturers are mandated by the FDA’s 21CFR 820 quality system regulation to utilize good judgment when developing their quality system and apply those sections of the FDA quality system (QS) regulation that are applicable to their specific products and operations. Drug manufacturers are governed by the GMP requirements under 21CFR 211.
FCA consultants work with site personnel to ensure that both the quality system requirements for medical devices and the GMP requirements for drug manufacturers are met and are sustainable. We help ensure that procedures are in place to effectively manage the quality system elements and cGMP requirements, and are overseen by appropriate management responsibility and quality audits.