Live Webinar Implementing a Risk-Based Internal CGMP Annual Audit Program

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate ,Q/A and 90 mins Live Webinar.

Description

March 14, 2017 at 01:00 PM EST | 12:00 PM CST | 10:00 AM PST

How do you create and blend the Risk Management File findings into your annual audit plan? How is it established, maintained, formally updated, and documented?

Description

Structured, defined and scheduled internal CGMP compliance audits are a specific requirement of US FDA 21 CFR 820 and ISO 13485 (devices), implied in 21 CFR 210, 211 (pharma)
Structured, defined and scheduled internal CGMP compliance audits are a specific requirement of US FDA 21 CFR 820 and ISO 13485 (devices), implied in 21 CFR 210, 211 (pharma). The US FDA and the EU have stated that quality and regulatory activities are or should be “risk based”. So, how can a QMS audit program be structured and prioritized by risk? Use a 3-Phase approach to redistribute scarce resources and achieve a higher payoff in reduced liability, both civil and regulatory. How do you set-up the risk basis for subsequent action? How do you create and blend the Risk Management File findings into your annual audit plan? How is it established, maintained, formally updated, and documented?.

Areas Covered

-- FDA's Q9 and ISO 14971:2001 -- Recent regulatory expectations
-- The Internal CGMP Compliance Audit Plan -- Some a pproaches
-- How to use your Risk Management Tools (per Q9 and ISO 14971)
-- Risk by 21 CFR categories; ISO 13485; ISO 9001
-- The cGMPs and Process / Equipment / Facility Validations
-- QSIT for analysis of QMS audit’s high risk concerns
-- Design Control -- expanded
-- CAPA – a crucial series of risk-based lifecycle deliverables
-- P&PC / HACCP – risk analysis is inherent

Who will Benefit

-- Senior management, project leaders, internal / external consultants
-- Regulatory affairs
-- Quality systems personnel
-- All charged with implementing, administering and supporting the QMS (Quality Management System), including new product development, regulatory submissions, initiating / overseeing company-wide quality management / planning, and desiring to utilize a risk-justified approach
-- CAPA, P&PC and training personnel
All who could be selected as a member of a CGMP Audit Team

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

John E Lincoln

Principal, J. E. Lincoln and Associates LLC

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry 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 / CGMP audits and 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, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

In addition, he 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. He is a graduate of UCLA.

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