FDA Bundle

COURSE BUNDLES WITH XOOLI

FDA Inspections for FDA Regulated Companies Bundle from Morf Media Inc.
Now on Mobile Devices

COURSE BUNDLES WITH MORF

FDA Inspections for FDA Regulated Companies Bundle from Morf Media Inc.
Now on Mobile Devices

Inspection by the FDA or other foreign regulatory agencies for the purpose of certification is a normal part of the pharma, biotech or medical device manufacturing business. Regulated companies need to know the structure and typical processes of a regulatory agency inspection to ensure a positive outcome. This course bundle was co-developed with former FDA Inspector Larry Spears and contains comprehensive information on all inspection information.

WHAT YOU WILL LEARN

This module bundle clearly presents the facts about expected in­spection processes for organizations focused on pharma, biotech and medical device manufacturing.

This bundle trains personnel to meet inspection expectations and avoid pitfalls that often occur due to lack of knowledge or preparation. It is vital to company success for managers and quality assurance personnel to be aware of the requirements of inspection procedures.

“Our quality managers enjoyed using XOOLI and I appreciated how time and resource effective it is to offer mobile training to my staff.”

AVAILABLE LEVELS
BASIC & INTERMEDIATE

TOPICS COVERED

  • FDA Inspection Program Overview
  • Key factors for a successful FDA inspection
  • Quality System Readiness
  • Information Readiness
  • Organization Readiness
  • Manage Inspection Outcomes
  • Managing Regulatory Risk
  • Food Facility Inspections
  • Medical Device Inspections
  • 21 CFR 11 Inspections
  • FDA Quality Metrics
  • Corrective and Preventive Action (CAPA)
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PERFECT FOR

  • Senior Management
  • Quality Assurance and Control Managers and Personnel
  • Supply Chain and Logistics Managers
  • Regulatory Affairs Professionals
  • Process Development Scientists and Management
  • Manufacturing Personnel
  • Project Managers in the CMC arena
  • Facilities and Engineering Staff
  • Internal Auditors
  • Legal Departments

Expert preparation for hosting regulatory inspections
provides insight, improves processes, reduces citations and other negative circumstances, and improves work consistency.

Utilizing a risk-based approach,
this course provides a comprehensive overview of different inspection expectations in regards to quality system readiness, organization readiness, how to manage inspection outcomes and other important processes.

XOOLI is the World’s Easiest to Use Mobile & Social Enterprise Talent Development Platform 

Course Author Bio

Mr. Larry Spears
FDA Consultant for Morf Media, USA

Larry is the Executive VP of Regulatory Affairs/Quality Assurance for Touchstone Technologies Silicon Valley, Inc. “Knowledge is Power”. He has deep regulatory expertise from over 35 years experience in government and consulting.

Mr. Spears provides global regulatory strategy consultation to Life Science companies primarily in medical devices/diagnostics and pharmaceuticals with a focus on quality systems gap assessments, FDA mock inspections, quality system development and planning, and remediation for FDA inspection findings including, among others, CAPA and complaints, design controls, supplier controls, production management, and training.

Ms. Angela Bazigos
Chief Compliance Officer and Head of Life Sciences

Honored by Stanford Who’s Who for contributions to the Life Sciences Industry, Angela has more than 40 years of experience working with life sciences and healthcare organizations around the world. She is a Past President of PRCSQA, a member of the SQA, CVIC, ASQ, DIA and RAPS. She co-authored Computerized Systems in Clinical Research/Current Data Quality and Data Integrity Concepts with FDA and is a frequent contributor to international and industry publications. Ms. Bazigos was recently quoted in the Wall Street Journal on Using Training to Bring Compliance to the Boardroom. Ms. Bazigos additionally served as CCO for Prime Genomics, and held executive roles at Incyte Genomics, Roche and Counsyl among others.