Because the FDA Said So Convincing the Non-Believer You are going - - PowerPoint PPT Presentation

Because the FDA Said So

Convincing the Non-Believer

What do you hear?

Everything doesn’t need to be in a procedure. Why do we have to do this? Is this really necessary? You are going to impact the timeline w/ this last minute requirement.

Agenda

• What are the common challenges?
• Where do I go to prove what is required?
• Walk thru examples

Common Challenges

• Documentation – defining what is required
• Qualifications – validating it vs. verification
• Records – recording what was done; i.e., the evidence

Documentation / Procedures

Qualification

Records

Guidance on Requirements

• FDA

– Preamble to the CFR – Recognized Harmonized

Standards

– Guidance Documents – QUSIT / MDSAP – 483s – Warning Letters

• EU

– ISO Standards – NB-MED

Procedures: QUSIT Guide

• Procedures referenced in the

QSIT guide:

– High-level Quality System – Management Review – Quality Audit – Production – Designated Management

Representative

– Purchasing Controls – Design Control – Design Input – Design Output – Design Review – Change Control – CAPA – Failure Investigation – Corrective & Preventative Action – CAPA Inputs – MDR Procedures – Medical Device Tracking – Control, Monitoring, & Produce

Acceptance

– Process Validation – Sterilization Process Controls

Qualification

• Preamble to CFR 820

Qualification

Notified Body Guidance Documents

• http://www.team-nb.org/nb-med-documents/

Notified Body Guidance Documents

Guidance on Requirements

• Industry / Societies

– ANSI / ASTM – GHTF / IMDRF – AAMI – ISTA – ASQ – USP

• Businesses

– Emergo Group – Quality Council of Indiana

• Network!

– Talk to people & ask – Attend meetings

Industry / Society Guidance

Industry / Society Guidance

Examples

Thought process to convince the non-believer.

Everything doesn’t need to be in a procedure.

• Step 1: Pull the regulations; ISO13485 & 21

CFR Part 820

• Step 2: Pull the QSIT Guide
• Step 3: Pull recent 483s &/or Warning

Letters

Design Control

Step 1

• 21 CFR Part 820

– Section 820.30 (a) General. (1) Each

manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.

– (c) Design input. Each manufacturer shall

establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and

• patient. The procedures shall include a

mechanism for addressing incomplete, ambiguous, or conflicting requirements.

• ISO13485

– 7.3.1 The organization shall

document procedures for design and development.

– 7.3.8 The organization shall

document procedures for transfer of design and development outputs to

• manufacturing. These procedures

shall ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications and that production capability can meet product requirements.

– 7.3.9 The organization shall

document procedures to control design and development changes.

Step 1

• 21 CFR Part 820

–

(d) Design output. Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified.

–

(e) Design review. Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design

• development. The procedures shall ensure that

participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed.

–

(f) Design verification. Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements.

–

(g) Design validation. Each manufacturer shall establish and maintain procedures for validating the device design.

–

(h) Design transfer. Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.

–

(i) Design changes. Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.

Step 2

• QSIT

Step 3 – Recent Warning Letter

Step 3 – Recent Warning Letter (cont.)

Is this really necessary?

• Step 1: Pull the regulations; ISO13485 & 21

CFR Part 820

• Step 2: Pull guidance documents
• Step 3: Pull recent 483s &/or Warning

Letters

Validation

Step 1 – 21 CFR Part 820

Step 1 – ISO 13485

Step 2 – Guidance Document

Step 2 – Guidance Documents

Step 3 – Recent Warning Letter

Why do we have to do this?

• Step 1: Pull the regulations; ISO13485 & 21

CFR Part 820

• Step 2: Pull recent 483s &/or Warning

Letters

Records

Step 1 – 21 CFR Part 820

Step 1 – 21 CFR Part 820

Step 2 – ISO13485

• 8.3.4 Rework
• The organization shall perform rework in accordance with documented

procedures that takes into account the potential adverse effect of the rework on the product. These procedures shall undergo the same review and approval as the original procedure.

• After the completion of rework, product shall be verified to ensure that it

meets applicable acceptance criteria and regulatory requirements.

• Records of rework shall be maintained (see 4.2.5).

Step 3 – Recent 483

Thank-you!

Tiffany Abrams tiffany_abrams@edwards.com