Workshop 1: Responding to 483 Observations. 13 TH Annual Pharma Conference Tuesday, February 14, 2017

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1 Workshop 1: Responding to 483 Observations 13 TH Annual Pharma Conference Tuesday, February 14,

2 Workshop 1: Responding to 483 Observations Moderator Kip Hanks - FDA Facilitators Ashley Bilbo LifeNet Health Erica Agy Seattle Cancer Care Alliance Kristin Mathes Lions VisionGift Joel Osborne - MTF 2

3 Intro Guidelines for Preparing a 483 Response Letter FDA s Main Interests In Reviewing an Establishment s Responses Avoiding Common Pitfalls Team Exercise 3

4 Guidelines for Preparing a 483 Response Letter The importance of timeliness of submitting written responses to the district office Begin with a statement of commitment to comply with applicable laws and regulations Make it clear that your company understands its obligation under the law and is serious about its intent to follow the law Address each item on the FDA-483 or in the Warning Letter individually 4

5 Guidelines for Preparing a 483 Response Letter (cont.) Quote each specific citation verbatim and follow with your reply Where there is actual or potential impact on product excursions in critical process parameters repeated failures or deviations unresolved environmental monitoring excursions provide an assessment of product impact and the basis for the assessment 5

6 Guidelines for Preparing a 483 Response Letter (cont.) Describe the scope of the corrective action plan including: Report of the corrective action for each of the specific examples listed in the observation Steps taken to address any other area which may be subject to the same deficiency Measures taken to prevent the reoccurrence of the problem in the future. Provide a timeline for submitting follow-up information to the district office 6

7 FDA s Main Interests In Reviewing an Establishment s Responses Impact on the product Establishment's actions to the specific citation Root cause failure implication to the Quality System How and why did this happen What could have prevented it Who was responsible Actions to prevent reoccurrence 7

8 Avoiding Common Pitfalls Incorrectly ascribing root cause to a lack of training or poor training Setting unattainable goals Too Much or Too Little Supporting Documentation Downplaying the significance of a reported complaint Minimizing problems by stating that others in the industry do the same things Failing to follow through with verification audits to ensure that corrective actions have been satisfactorily implemented 8

9 Corresponding with FDA Opening statement On behalf of the Acme Tissue Bank (ATB), I am responding to the observations noted on Form 483, [ Date issued]. ATB takes its responsibility to comply with the Tissue Regulations seriously and is fully committed to ensuring compliance with the Food and Drug Administration s ( FDA or the agency ) regulations and guidances. As outlined in greater detail, the company has completed, or is in the process of implementing, corrective actions to address each of the agency s observations. FDA s original observations and the company s response and timeline for completing these actions are provided below. Closing statement ATB is committed to providing quality HCT/Ps and medical devices to the medical community and ultimately the recipient. The inspection performed by the FDA has enabled ATB to improve its Quality System to attain this goal. An update indicating our progress will be provided to the FDA by the dates indicated above. Please call me at [phone #] if you have any questions. 9

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11 Team Exercise Participants will be divided into teams Each team will designate a scribe and a spokesman Teams will be given a 483 Observation Each 483 Observation is different Teams will formulate a written response 30 minutes May use paper or prepare electronically Team spokesman will present the response 5 minutes per team 11