Change Control Best Practices - Avoiding Unintended Consequences of Changes

Course Description: With FDA citing inadequate change control constantly in its 483s and Warning Letters, the prerequisite to ensure that changes are accurately described, justified, assessed for risk, implemented, and documented has come to the fore. Changes must also be prospectively reviewed by appropriate subject matter experts. Furthermore, certain major changes (e.g. manufacturing, specifications) may require regulatory filings and/or prior regulatory approval. This seminar will guide all personnel involved in proposing, assessing, and implementing changes to understand and successfully apply the fundamental change control steps and best practices. The key focus will remain on: Change proposals Justification / risk assessment Change execution / implementation Note: Use coupon code 232082 and get 10% off on registration.

del 16 al 17 de abril de 2015 | Boston (Estados Unidos)


Boston, MA

Boston, MA

Boston (Estados Unidos)


Secretaría del Congreso

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