My Cart 0 items

2-day In-person Seminar

Effective Internal and External Quality Assurance Auditing for FDA Regulated Industry


July 27th & 28th, 2017

Time: 9:00 AM to 6:00 PM

Philadelphia, PA

Venue: WILL BE ANNOUNCED SOON


Director : David R. Dills

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

  Price: $1,295.00
(Seminar Fee for One Delegate)

  Register for 5 attendees   Price: $3,885.00
      $6,475.00 You Save: $2,590.00 (40%)*
Register now and save $200. (Early Bird)
  • ?
    • Until June 10, Early Bird Price: $1,295.00 From June 11 to July 25, Regular Price: $1,495.00
Course "Effective Internal and External Quality Assurance Auditing for FDA Regulated Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
  • Principles and Audit Planning
  • Planning and preparation
  • Internal audits are critical element of your quality management system.
  • Your approach must be both systematic and documented to remain compliant
  • Information from an internal audit provides management with the knowledge they need to show how effectively the company maintains the quality of the product and their processes
  • Audit types and techniques
  • Establishing an audit program for suppliers, contractors and company sites
  • Internal vs. external audits
  • The audit processes
  • Regulatory Expectations
  • How to develop and implement an efficient and effective audit program
  • Common problems
  • Red-flags that your program is not effective
  • Risk Analysis techniques
  • Audit Program Structure
  • The auditing process - steps and tools
  • Documentation and communication
  • Linkages within your Quality System to ensure audits lead to effective solutions and lasting improvement while reducing regulatory and compliance exposure
  • And Much More...

Why should you attend:

  • Clear Understanding of Auditing Fundamentals
  • Understand Audit Preparation and Planning
  • Learn best techniques for Audit Performance
  • Learn best practices for Audit Reporting
  • How to address Audit Follow-up and Closure efficiently and effectively
  • Understand the requirements and expectations for being an effective auditor
  • How to develop into an even better auditor
  • How to structure, plan and manage your audits
  • How to develop your technical and non-technical skills
  • How to perform your best audit ever

Areas Covered in the Session:

  • The fundamentals of process based auditing
  • Four Phases of Auditing: Preparation, Performance, Reporting, Follow-up & Closure
  • ISO 19011 is the standard that sets forth guidelines for auditing management systems
  • Different Types of Audits: Product, Process, System, Quality System, Supplier, Regulatory, Quality System, etc.
  • More robust methodologies for preparing and conducting audits
  • Auditor competence
  • Enhanced audit criteria that consider efficiency and effectiveness
  • Applied statistics for auditing when it's necessary

Who will benefit:

This seminar will provide an overview and in-depth snapshot and a refresh of internal and external auditing. Those interested in how to prepare for a QA audit and how to enhance their internal/external quality audit system as a valuable regulatory compliance tool will also benefit from this course. Employees or functional areas who will benefit include:

  • Clinical Research Associates
  • Clinical Project Managers
  • Regulatory Affairs Professionals
  • Clinical Investigators and Clinical Research
  • Regulatory Affairs Management
  • Regulatory Affairs Specialists
  • Regulatory Project Leads/SME's
  • QA Auditors
  • Supplier Auditors
  • GxP Auditors
  • Compliance Specialists
  • Clinical Affairs
  • Quality Manager
  • Quality Assurance
  • Production/Operations
  • Consultants

Day 1 Schedule


Auditing
  • Introductions and Background
  • Four Phases of Auditing
  • An auditor may specialize in types of audits based on the audit purpose, such as to verify compliance, conformance, or performance
  • Some audits have special administrative purposes such as auditing documents, risk, or performance or following up on completed corrective actions
  • Purpose and Scope of the internal and external Quality Audit System
  • Responsibilities and Authority
  • Types of Audits
  • Roles and Responsibilities
  • Audit Plan
  • Audit Team
  • Audit process
  • Auditor Skills and Competencies
  • What makes a good auditor?
  • Communication skills - questioning and listening
  • Body language and non-verbal communication
  • Overcoming apathy, resistance and aggression
  • Effective note taking
  • Auditor continuing professional development
  • Assessing the auditor
  • Managing auditors
  • Writing ideal Audit Reports
  • Corrective action follow-up and interactions with the Auditee
  • Regulatory background - requirements for each type of operation
  • Strategies and Techniques of auditing
  • Regulatory Inspections and the correlation to Audits
  • Auditing Guidelines and Resources

Exercise and Recap of Day 1
  • Interactive Discussions
  • Review of Auditing Documents

Day 2 Schedule


Auditing
  • Recap from Day 1
  • Tools for documenting audit observations and managing corrective and preventive actions
  • Good Clinical Practice Audits, Good Laboratory Practice Audits and Good Manufacturing Practices/Quality System Audits
  • Supplier Audits
  • Process: Planning, Scheduling, Audit Conduct/Performance, Reporting of Audit Results and Next Step
  • Show the auditor you do what you say
  • Tips for Passing Your FDA, Internal and External Audits with Confidence
  • Best Practices for Auditing

Exercise and Recap of Day 2

  • Interactive Discussions
  • Review of Auditing Documents

Debrief/Adjourn
  • Recap of topics and key discussion points and take away message
  • FAQs and latest auditing trends
Want to register by P.O/Check?
We facilitate registration by P.O/Checks!
Complete your registration in just a few easy steps
Please just download, fill out the registration form and send it to us either by email to support@globalcompliancepanel.com or just fax us at 302 288 6884.
Once the form is received, an invoice will be generated and sent back to your fax number.
Following this just send us your purchase order by fax at 302 288 6884
Click here to download Registration form
In case you wish to register by using check
In case you wish to register by using check, please make a check to NetZealous LLC DBA GlobalCompliancePanel.com and mail it to the below address.
NetZealous LLC,
DBA GlobalCompliancePanel,
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
Phone: 1800 447 9407

Want to register by Wire Transfer?
Please call any of our representatives on 1800 447 9407 to help you completed the transfer.
Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

David R. Dills

Regulatory Affairs & Compliance Consultant,

David R. Dills, Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA, Design Dossiers, Technical Files, CMC, NDA, and IDE submissions, currently serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. His background encompasses broad capabilities in regulatory and compliance oversight and governance, including CAPA, Design Controls, Validation, Software Quality with regulatory oversight, FDA Mock Inspections, remediating documentation management systems, Supplier Quality, Adverse Event Reporting, Product Complaints, GxP Training, interpretation and applicability of FDA and international regulations and standards, postmarketing surveillance, ISO 13485 and CE Mark, Medical Device/IVD/Active Implantable Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EMEA and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.

Location: Philadelphia, PA Hotel: WILL BE ANNOUNCED SOON  

Copyright © 2016 GlobalCompliancePanel. All rights reserved. Netzealous