Course Description:
The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Compliance auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.
In this two day workshop conference you will learn the background and basics for regulatory compliance auditing.
Learning Objectives:
Upon completing this course participants should:
- Understand what a regulatory compliance audit is.
- Understand the background and basics of regulatory compliance auditing.
- Understand proper Auditor conduct.
- Communication
- Dress
- Punctuality
- Difficult situations
- Learn the necessary skills for conducting audits.
- Understand how to prepare and plan for a regulatory compliance audit.
- Understand and know how to properly perform an audit.
- Opening meeting
- Touring the facility
- Questions
- Observations
- Close out meeting
- Understand the types of regulatory compliance audits
- Learn proper questioning techniques
- Understand proper audit observation classification
- Learn to write an audit report
- Understand conducting a follow up audit
- Learn how to become Lead Auditor certified
- ASQ Certification
- ISO Certification
- Medical Device Certification
Seminar Fee Includes:
Who will Benefit:
This course is designed for people tasked with performing internal and external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation. The following personnel will benefit from the course:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production supervisors
- Validation engineers
- Manufacturing engineers
- Production engineers
- Design engineers
- Process owners
- Quality engineers
- Quality auditors
- Document control specialists
Course Outline:
| Day 1 (8:30 AM – 4:30 PM) | Day 2 (8:30 AM – 4:30 PM) | ||
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Meet Your Instructor
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Joy McElroy Principle Consultant at Maynard Consulting Company Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world. |
Register Now
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ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
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Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to Register for the Seminar/Conference/Event
Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.
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