FDA INSPECTION READINESS & FORM 483 & WARNING LETTER REMEDIATION
Inspection Readiness (IR) is a process of getting ready for an inspection by a regulatory authority (such as FDA), which is conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the clinical trial. Every pharma company is responsible for inspection readiness through providing the training to employees and ensuring their understanding and application of policies, standards, and procedures. Pharma organizations should allocate the right number of qualified resources to assure that inspection teams are in place to manage activities before, during, and after inspections. Clinical Operation Managers are traditionally driving the IR activities for the given clinical study with Quality Assurance (QA) support. Manufacturing/CMC Inspection Readiness is usually covered by separate QA GMP group. In both cases, IR is a cross-functional effort.
Surviving an FDA inspection is all about managing risk—understanding your weaknesses, anticipating how investigators will perceive them and preparing your staff to respond. The human factor can make or break an inspection and may present the biggest risk of all if you are not fully prepared. You can’t completely control what your employees will say, but careful consideration and preparation will minimize problems. MEDVACON can assist in preparing your organization for the inspection. MEDVACON delivers rigorous and comprehensive FDA Inspection Readiness and FDA remediation services that are designed to provide cost efficient resolution of FDA readiness and remediation activities.
An FDA 483 or Warning Letter often only addresses a small portion of the true deficiencies in the quality system. MEDVACON can help determine the actual depth and breadth of the quality system deficiencies via a comprehensive FDA Compliance GAP Assessment. The GAP Assessment includes preforming baseline audits, and developing a remediation plan to address all of the deficiencies and bring the Quality System or specific sub-section into compliance. For clients that already know the areas that need attention, MEDVACON's staff of compliance experts are at the ready to tackle those specific areas.
Surviving an FDA inspection is all about managing risk—understanding your weaknesses, anticipating how investigators will perceive them and preparing your staff to respond. The human factor can make or break an inspection and may present the biggest risk of all if you are not fully prepared. You can’t completely control what your employees will say, but careful consideration and preparation will minimize problems. MEDVACON can assist in preparing your organization for the inspection. MEDVACON delivers rigorous and comprehensive FDA Inspection Readiness and FDA remediation services that are designed to provide cost efficient resolution of FDA readiness and remediation activities.
An FDA 483 or Warning Letter often only addresses a small portion of the true deficiencies in the quality system. MEDVACON can help determine the actual depth and breadth of the quality system deficiencies via a comprehensive FDA Compliance GAP Assessment. The GAP Assessment includes preforming baseline audits, and developing a remediation plan to address all of the deficiencies and bring the Quality System or specific sub-section into compliance. For clients that already know the areas that need attention, MEDVACON's staff of compliance experts are at the ready to tackle those specific areas.
Example Projects
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Warning Letter Remediation - Aseptic Combination Product Manufacturing Client
MEDVACON was engaged by an Aseptic Combination Product client in response to an FDA Warning letter to conduct investigations into deviations and non-conformance's in the aseptic manufacturing suites used to produce the combination product. MEDVACON deployed a team of experts to conduct the investigations and assist this client in meeting stringent FDA commitment timelines. In performing these activities MEDVACON was engaged by the client to resolve a highly technical issue with the combination product mechanical components and successfully identified the issue and implemented a change to the process. While the FDA commitment timelines were met the team remains in place to assist this client with ongoing investigations and closeouts and Quality Systems Consulting Services.
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Pre-Approval Inspection (PAI) Readiness - Pharmaceuticals
MEDVACON was engaged by a pharmaceutical client to assess and remediate their Quality System in anticipation of an FDA Pre-Approval Inspection. MEDVACON deployed a team of experts at the client site to assess and identify the GAPs. Once the initiative of identifying the GAPs was complete, and with client buy-in on the approach, the MEDVACON team put a plan in place to remediate the identified GAPs. The plan included a holistic remediation of the entire quality system with a focus on automation of the quality system and ensuring compliance of that initiative from a CSV and 21 CFR PArt 11 perspective.
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