FDA Ready Consulting

Inspection Prep Strategy

Companies fail inspections when they do not begin preparations early enough. Most companies feel that there will be more time "later," but everyone also recognizes that time becomes compressed around filing, and there is no patience for regulatory problems with marketed products. This timeline has been proven to work at large and small companies.

Each of these pieces follows an established program customized for your company's needs. FDAReady has performed dozens of these exercises, so you can learn from the mistakes of others.

Timing	Milestones	Goals
24 months before filing	Gap Analysis 1	Review quality systems. Implement programs so a company can diagnose and correct their own problems.Check long lead-time issues (facility, process, stability).
12-18 months before filing	Gap Analysis 2	Make adjustments to the systems from Gap Analysis 1. Begin more detailed review of other systems, as appropriate for company and technology.
4-9 months before filing	Gap Analysis 3	Diagnose problems and find solutions to problems found when compiling the submission or making pivotal batches.
3-6 months before filing	Training on Inspection Management
3-6 months before filing	Mock Inspection 1	Typically, the first attempt at managing requests and tours goes poorly, so this exercise is designed to customize solutions to a company's staff, organization, and size.
1-2 months before filing	Mock Inspection 2	This the first definitive mock inspection with lessons learned from the first mock inspection. Changes to the inspection management program are adjustments, not major changes.
1 month before or after filing	Mock Inspection 3	The final dress rehearsal to check that everything works before the show.

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