ComplianceOnline

Major CGMP Issues for 2012

Instructor: John E Lincoln
Product ID: 702185
Training Level: Intermediate to Advanced
  • Duration: 90 Min

recorded version

$399.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$599.00
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Read Frequently Asked Questions

This 90-minute training on Major cGMP Issues for 2012 will show what drug and device companies can do proactively to address failures over cGMP issues and ensure better regulatory compliance.

Course "Major CGMP Issues for 2012" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820). They are then required to translate those regulations into procedures and work instructions.

Many companies who have successfully done that in the past are now failing audits, facing major recall, and multi-million dollar fines. What failures in the GMPs have led to this? What assumptions have proven to be invalid? This webinar will address the above and all of the following:

  • What are the key areas of non-compliance?
  • What are the 'new' areas for increased awareness, focus, and remediation? What new concerns need to be addressed now?
  • What are the trends and areas of FDA concern on which to focus in the coming year? What approaches are now mandated?
  • How does ICH Q_ documents provide guidance for all FDA regulated industries, not just pharmaceuticals?
  • Where does Product Risk Management fit into the process?
  • How to maximize any remedial action process against scarce resources?

This training will cover areas of major concern for the coming year and provide proven tips for a heightened cGMP compliance.

Areas Covered in the Seminar:

  • Recent industry trends - bad and good.
  • Major foreseeable problem areas for 2012.
  • What's behind these trends?
  • A company gap analysis.
  • Correcting problem-prone areas.

Who Will Benefit:

  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • R&D and Engineering
  • All personnel involved in a U.S. FDA-regulated environment especially those involved in new product development, line extensions, and incremental product improvements, having to evaluate those changes to existing FDA-cleared 510(K)'s, and then document their decisions in harmony with regulations.

Instructor Profile:

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 of which as head of his own consulting company. John 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 incl+D33uding QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

In addition, John 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. John is a graduate of UCLA.

Topic Background:

The last two years have seen major initiatives at the FDA; as well as prominent drug and device failures over cGMP issues, resulting in recalls, lawsuits, and even possible criminal prosecution. Class action lawsuits initiate other areas of concern. A continuing push by the Agency to get tougher and strengthen enforcement is one result. Bad publicity affecting once stellar names in the regulated industry is another. Public outcry for a more proactive FDA continues.

Current FDA oversight methods are claimed to not be providing the product safety or efficacy seemingly promised. What can companies do proactively to address these concerns and better ensure better regulatory compliance. Such high-profile field problems and FDA findings point to areas for increased surveillance. What can companies do in addressing these issues? For most companies, the fixes are not rocket-science, but require an evaluation and emphasis of these areas for heightened CGMP compliance.

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well done. everything was available when promised and accessible.
- Anonymous

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