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The Common Sense of Quality Auditing

Aug 12, 2019
Bethesda, MD

  • Education
  • The Americas
Closed

Overview

DATE CHANGE
Please be advised that training course 527 The Common Sense of Quality Auditing has been rescheduled to Aug 12.

The days of the stern-faced auditor conducting an intense audit and creating a stressed-out auditee are over… or should be! Common sense tells us that just as the pharmaceutical industry has changed, so must the audit. While the goal of the audit remains the same (i.e., a systematic and independent examination to determine whether quality and related activities within an organization demonstrate a state of control), its primary objective is to benefit the function being audited. The success of this objective is dependent on both the auditor and the auditee. This one-day training course journeys through the adventures of an audit and will tour three themes: communication, preparation and credibility.

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Agenda

  • Training courses run from 8:30 to 16:00 each day, unless otherwise noted. An agenda will be provided on the first day of the training course.

Trainers

Kerry Potter
Kerry Potter
Summit Consulting, Inc.
Bio
Kerry Potter
Summit Consulting, Inc.

Kerry Potter gained his pharmaceutical manufacturing (API and Finished) experience during his 28-year career with Merck in Elkton, Virginia. Kerry’s career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included project manager of laboratory assessment, FDA Quality Management System implementation, and GMP training (annual, ongoing, new hire); administrator of site quality performance, OSHA regulations and Process Safety Management training, as well as internal and external public relations.

He has received qualifications and certifications in the areas of facilitation and training, including instructional design and competency-based curricula. Kerry also received local and national awards for chapter management during his tenure as President of the Blue Ridge Section of the American Society for Quality Control, now the ASQ. Other current and past affiliations include Association for GXP Excellence, American Society for Training & Development, PDA, GMP-Training & Education Association, and Association for Quality & Participation. He is also a certified Pro-Trainer and facilitator, and an Advanced Toastmaster (www.toastmasters.org).

In 2006, Kerry founded Summit Consulting, Inc. in order to offer a combination of business and hands-on consultation, training and mentoring services for the pharmaceutical manufacturing industry. This combination is founded on the areas of project management of regulatory compliance and quality systems; quality assurance; quality systems audits; change control; laboratory testing; design and presentation of regulatory training; employee development; GMP and documentation; and regulatory agency interaction and communication. Kerry serves as the principal consultant of Summit and is currently supporting clients with Quality Systems remediation efforts, and GMP mentoring for pharmaceutical and API manufacturing. He also facilitates public and private on-site training seminars on regulatory compliance topics, both domestically and in Europe.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Describe the impact of proper auditee notification
    2. Describe the best characteristics of and assemble an Audit Team
    3. Define pre-audit activities for your team and area
    4. Determine auditing strategies
    5. Evaluate skills and characteristics of a quality auditor
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved with internal audits.

    Departments
    Quality Assurance, Manufacturing, Quality Control, Regulatory Affairs

    Roles
    Auditor, Auditee, Specialist, Analyst, Supervisor, Manager, Director

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Early Registration
Registration Type Price By June 28, 2019
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $839







Regular Registration
Registration Type Price After June 28, 2019
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $839







* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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