Need Guidance for Auditing? Here are 4 Webinars for Audit Success

This package training has been specifically designed to help attendees prepare for FDA and EU inspections. It will provide a background and understanding of the role played by the regulatory inspectors, and the administrative and enforcement powers. Attendees will be walked through the key stages of FDA and EU inspection processes and understands the various types of inspections that can be carried out. These presentations will also help you to learn why audit interviews are important and what it means for auditors to be fair during an interview, and most importantly how to maintain a good Design History File (DHF) that will help a manufacturer in a regulatory compliance audit.
Instructor: Marie Dorat, Larry Whittington, Mercedes Massana
Product ID: PACK70032

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Free shipment of CDs within 72 hours from the date of purchase
  • Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id

Webinar Topics:

Who will benefit?

  • Quality Assurance Managers and Auditors
  • Regulatory Affairs
  • Document Management
  • Other professionals who want to know more about inspection guidelines
  • Internal Auditors Beginner
  • Future Internal Auditors
  • Audit Program Managers
  • Consultants
  • Other professionals in the manufacturing, services, and software sectors that are involved with quality, environmental, or safety audits.
  • R&D Engineers
  • Quality Engineers
  • Project Managers
  • Engineering Managers and Personnel

Webinars included in the Package:

FDA vs EU Inspections - Getting Prepared and What are Differences (Duration: 60 Minutes)

This training is a comparative look at FDA & EU regulations to help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings. The consequences if a company does not pass an inspection are time consuming, delayed product approvals, and could lead to civil or even criminal litigation by the FDA and EU inspection agencies.

Objectives of the Presentation:

  • Differences between FDA and EU Inspections including the FDA and EU joint inspection programmer
  • How to prepare for EMA and FDA audit
  • How to plan for an audit or inspection using checklists/ FDA/EMEA inspection guidelines
  • Tips for employees before the inspect
  • Tips on proper responses to prepare for audit/inspection Interviews
  • Setting up a Triage to ensure that required documents are available
  • How to interact with the inspectors-DOs and DON'Ts
  • How to reply to inspection reports, 483's and EU inspection finding
  • Post inspection actions - implementing appropriate CAPAs in response to audit findings

Auditing 101 (Duration: 60 Minutes)

The Course clarifies the role of the new auditor or internal auditor and explains their responsibilities. The session will also discuss interactions with others in key roles as part of the audit as well as exploring some techniques used in auditing.

Objectives of the Presentation:

  • Overview of internal auditing
  • Planning the audit
  • Opening meeting
  • Who should participate?
  • Auditing techniques
  • Wrapping up the audit
  • The closing meeting
  • Writing the audit report

Instructor Profile:

Marie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies process the necessary documents for international product distribution.

Ms. Dorat has 13 years' experience in quality assurance and regulatory affairs in the pharmaceutical/Medical Device & IVD industry, including auditing clinical trials, manufacturers, and distributors in the US and internationally. She has held a number of senior QA/RA positions. She has worked for several companies including Pfizer, and Alere She has lectured at conferences and provides on-site training courses on QA and GxP issues.

How to Improve the Effectiveness of Audit Interviews (Duration: 90 Minutes)

This webinar will discuss why we should conduct audits and reviews the six major audit activities. It will also discuss about auditor responsibilities, followed by why audit interviews are important and what it means for auditors to be fair during an interview along with the basic steps of an audit interview. The instructor will discuss the different types of questions to be asked in an interview and provide sample questions for your use. Since auditors take notes during interviews, the webinar will present good note taking practices and offer some additional interview tips.

Objectives of the Presentation:

  • Audit definitions and audit activities
  • Auditor role and audit interviews
  • Audit approach and auditor fairness
  • Interview steps and checklist use
  • Question types and sample questions
  • Questioning methods and note taking
  • Auditor skills and evidence sources
  • Nonconformity reasons and auditee reactions
  • Audit principles and benefits

Instructor Profile:

Larry Whittington is President of Whittington & Associates, a training, consulting, and auditing company. He is an Exemplar Global and IRCA Lead Auditor, has a Master of Engineering degree from the University of Florida, and has ASQ certifications as a Quality Auditor and Software Quality Engineer.

Larry has developed requirements, implementation, documentation, and auditing courses for quality, environmental, and safety management system standards. He has taught hundreds of classes to thousands of students. His free newsletter on quality and auditing topics has been published for more than 15 years and is read by thousands of subscribers each month.

Creating a Good Design History File (DHF) for Audit Success (Duration: 75 Minutes)

The webinar will cover the structure of a DHF and steps to ensure that the DHF is completed as the design and development process progresses. The DHF needs to be maintained as design changes are performed. Information in the DHF can help facilitate design decisions, which often can affect the safety of the device. The DHF provides the knowledge base needed for the manufacturer to maintain the device. It also provides the secrets to a successful Design Control audit.

Objectives of the Presentation:

  • DHF structures that work well for audits
  • Documents that should and should not go into a DHF
  • When does a DHF needs to be created
  • What to look for when auditing a DHF
  • How to address issues with the DHF
  • The usefulness of the DHF in continuing to maintain the product after launch
  • DHF ownership when third parties are involved

Instructor Profile:

Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over thirty years of experience in the Medical Device industry; Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems. She has been responsible for establishing processes and leading groups of engineering in the following disciplines: Systems Engineering, Risk Management, Requirements Management, Verification and Validation, Process Improvements, Project Management, Software Systems Validation, Process Validation. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes is well versed in FDA and ISO regulations.

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