ComplianceOnline

Combination Drug/Device Products CGMPs - Final Rule

Instructor: John E Lincoln
Product ID: 702810
Training Level: Intermediate to Advanced
  • Duration: 90 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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.

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.

This session will provide valuable assistance to all regulated companies in evaluating their existing or proposed CGMP compliance and internal audit emphasis for the production of combination products, as a sub-contractor or primary manufacturer. Once you have recognized the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure compliance to the new rule.

Areas Covered in the Webinar:

  • The Four Basic Types of Combination Products
    1. two or more of device, drug, biologic;
    2. physically combined; or
    3. packaged together; or
    4. packaged separately but intended for use only with another, different type of medical product ("cross-labeling").
  • The CGMP "Operating System"
  • Constituent Parts
  • Applicability of 21 CFR 210/211, 600-680, 820, and 1271
  • The Two Ways to Compliance
  • Single-type Constituent Part Facilities
  • How to Address CGMP "Conflict"

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

Instructor Profile:

John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. Mr. Lincoln is a graduate of UCLA.

Topic Background:

The U.S. FDA has issued the long-awaited CGMPs for Drug / Device and/ or Biologics Combination Products - 21 CFR Part 4, Final Rule, effective July 22, 2013.

This new final rule, "Current Good Manufacturing Practice Requirements for Combination Products", 21 CFR Part 4, clarifies many of these issues involving combination products including: 1) two or more of device, drug, biologic; 2) physically combined; or 3) packaged together; or 4) packaged separately but intended for use only with another, different type of medical product ("cross-labeling"). While the constituent parts of a combination product retain their regulatory status, there have not been specific regulations clarifying the applicability of the CGMPs to such combinations.

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