| |
|
|
|
GlobalCompliancePanel, Online Training Webinar
2010-09-28
The key to a successful audit is being able to communicate how your quality systems assure this state of control.
However, the arrival of an investigator for an inspection can still be an intimidating experience. The inspection can be less traumatic if the site and its personnel are properly prepared for the inspection and the investigator. During this hour presentation, you will find out how to prepare for the inspection and minimize stress, disorder, and any misinterpretation by the investigator during the inspection with careful planning of activities and effective resource development will support a successful inspection. Why you should attend: - Recognize the purpose of the inspection
- Learn how to properly communicate with the inspector
- Anticipate what information the investigator can and will request
- Know how to keep the inspection from being an “emotional” event.
- Know what is expected of you and your company
- Learn what not to say or do during an inspection.
- Recognize your audit responsibilities and vulnerabilities
- Identify the internal support system of a successful inspection
- Realize what steps you/your company should take to prepare for a successful inspection
Areas Covered in the Session: - Expectations of an audit
- Why the FDA conducts inspections
- Pre-planning and preparation activities
- What to do when the investigator arrives
- What documents to have ready and on hand
- Assignments and responsibilities for the inspection
- A review of Inspection Do's and Don'ts
- The Opening and Close-out Sessions
- Actions to take after the inspection is over
Who Will Benefit: - Site Quality Operations Managers
- Quality Assurance personnel
- Plant Managers
- Manufacturing Superintendents and Managers
- Individuals whose job knowledge and/or expertise may be required during an audit (Subject Matter Experts)
|
|
|
|
|
|
|
|
Organized by:
|
|
GlobalCompliancePanel |
|
|
Invited Speakers:
|
|
Kerry Paul Potter - Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included quality management of laboratory assessment, site GMP lead auditor, FDA QSIT/Quality Management System manager, 5S coordinator, GMP trainer (annual, ongoing, new hire), OSHA regulations and Process Safety Management training, as well as internal and external public relations.
Kerry is a graduate of James Madison University in Harrisonburg, VA (B.S. in Chemistry) and is an advanced Toastmaster. He has received qualifications and certifications in the areas of facilitation and training, including competency-based curricula. His past affiliations have included ASQ, ASTD, PDA, GMP-TEA, ASPI, and AQP. Kerry is the founder of Summit Consulting, Inc. and has been assisting firms in the areas of remediation and project management within the manufacturing and the laboratory functions for the past two years.
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
2010-09-27
|
|
|
|
|
|
|
|
Registration:
|
|
| live online training only for one participant | | |
|
|
|
E-mail:
|
|
webinars@GlobalCompliancePanel.com
|
|
|
|
|
|
|
|
|