Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

Instructor: John E Lincoln
Product ID: 700817
Training Level: Intermediate
  • 30
  • September 2020
    Wednesday
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 60 Min
This webinar will discuss the basic principles of P&PC, specifically as required by the FDA. Also attendees will learn the ISO 13485 and risk analysis / management requirements to evaluate the chief areas of an FDA CGMP compliance inspection / audit to locate areas for implementation and improvement in P&PC.

Live Online Training
September 30, Wednesday 10:00 AM PDT | 01:00 PM EDT | Duration: 60 Min

$329.00
One Dial-in One Attendee
$999.00
Purchase using Webinar All-Access Pass
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recorded version

$399.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$499.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$499.00

Live + Training CD/USB

$599.00

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Fax: +1-650-362-2367

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Read Frequently Asked Questions

Why Should You Attend:

There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance emphasis. The 2011 Pharma Process Validation Guidance Document emphasizes “P&PC” to ensure “homogeneity within batch” and “consistency between batches”, basic Dr. Deming, et al. Such changes in regulatory focus should have a major impact on individual compliance objectives, efforts and measurements of success. Using P&PC, lean, six sigma / SPC, together with process mapping / flow charting and HACCP, will yield major business benefits as well: Reduced waste / scrap, early warning of process shifts before non-conforming product is manufactured, increase efficiencies, minimal need for re-validations of equipment and/or process, and opportunities for improvement in quality, through-put. A case of regulatory / business “win-win”.

P&PC systems, metrics, and information / analysis, combined lean principles, and six sigma / SPC tools, and the FDA’s QSIT for medical devices and pharmaceutical requirements, together provide an effective, proactive and aggressive / robust methodology to maintain a production process in a “state of statistical control”, and in CGMP compliance for any regulated industry. Software, data integrity, and cybersecurity issues are considered. Such a system greatly reduces the need for equipment / process re-verification / -qualification / -validation.

Areas Covered in the Webinar:

  • P&PC and U.S. FDA CGMP / ISO 13485 / 9001 requirements
  • Tougher FDA Expectations / Requirements
  • Key elements of P&PC in a regulated industrial environment
  • Process mapping / flow charting and P&PC
  • FDA’s HACCP
  • Lean manufacturing’s role
  • Basis easy to learn / teach / use six sigma / SPC tools
  • “Risk-based” per ISO 14971 / ICH Q9
  • Documentation
  • Prove / maintain “in statistical control”
  • Document – lot / batch records, logs, analysis / charts…

Who Will Benefit:

  • Senior and middle management.
  • Quality Assurance/ Quality Control
  • Regulatory Affairs
  • R&D
  • Engineering
  • Operations
  • Production / Manufacturing
  • Staff and Line personnel
  • Sales and Marketing
Instructor Profile:
John E Lincoln

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years’ experience in U.S. FDA-regulated industries, 23 as an independent consultant. John has worked with companies from start-up to Fortune 100, worldwide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, submissions, process / product / equipment including QMS and software validations, ISO 14971 product risk management and human factors files / reports, Design History Files, Technical documentation. He's held positions in Engineering, QA, QAE, RA, 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, written numerous chapters for books on validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.

Follow us :
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Design Control Essentials for Medical Devices

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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