Combination Drug/Device Products CGMPs - Final Rule

29/10/2021, 10:57

Combination Drug/Device Products CGMPs - Final Rule | eMedEvents

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Combination Drug/Device Products CGMPs - Final Rule

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By ComplianceOnline

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 Webcasts 90 Minutes USD 299.00

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Conference Summary Combination Drug/Device Products CGMPs - Final Rule is organized by ComplianceOnline.

Who Will Benefit:

This training applies to personnel / companies primarily in the pharmaceutical, medical device, and biologics fields. The employees who will benefit include:

• Senior management

• Regulatory affairs

• Quality assurance

• Production

• Engineering

• All personnel involved in a U.S. FDA-regulated environment; especially those involved in CGMP compliance of affected regulated combination medical products Why Should You Attend:

There has been much past confusion on the production and handling of drug / device (and/or biologics) combination products. Companies involved in the production of such products have pieced together what they've considered the applicable elements of the pharma and device CGMPs, 21 CFR 210/211 and 820; sometimes with ambiguous advice from the agency, resulting in some disagreements during compliance audits.

Do not let yourself or your company be caught off guard by the new CGMP requirements for combination products. Attend this training to enhance your awareness of these new cGMP requirements and modify internal audits to match this FDA shift. This training will be a step-by-step review of the key elements of the U.S. FDA's new final rule, "Current Good Manufacturing Practice Requirements for Combination Products", 21 CFR Part 4. The presenter will evaluate and clarify many of the pertinent issues and questions that arise involving combination products. Description:

This training on combination product regulations will evaluate the chief areas of concern or change in the new CGMP requirements for combination products, 21 CFR Part 4, and clarify many of the issues and questions that arise involving combination products. Areas Covered in the Webinar:

• The Four Basic Types of Combination Products

• Constituent Parts

• The Two Ways to Compliance

• Single-type Constituent Part Facilities

• How to Address CGMP "Conflict"

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R d d Li k O l F https://www.emedevents.com/online-cme-courses/webcasts/combination-drug-device-products-cgmps-final-rule-2