FDA Audit, Quality Assurance Practices, Responsibilities and Expectations

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Seminar Details
Topic Name

FDA Audit, Quality Assurance Practices, Responsibilities and Expectations

Venue

Toronto, Canada

Dates

February 22 – 23, 2018

Timing

9 AM – 5 PM ET

Seminar Fee Includes:
Training
Lunch
AM-PM Tea/Coffee
Seminar Materials
USB with Presentation Handout
Attendance Certificate
Networking Sessions
$100 Gift Voucher for next seminar

Kenneth Christie

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities, and systems on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Mr. Christie was the Validation Manager at Parke-Davis’ Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.

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 at +1-416-915-4458 or email us at info@webinarcompliance.com

Payment Policy:

Payment is required to be made at least 2 business days prior to the date of the conference. We accept American Express, Visa and MasterCard.

To make payment by Wire Transfer, kindly call our Customer Support to assist you with completing your registration. Registrations by Wire are required to be made at least 7 business days before the date of the conference. Payments to be made in full.

To make payment through a check, please draw a check to FutureCorp Consulting INC. (our parent company), and kindly call Customer Support to assist you further. Registrations by Check payments are required to be made at least 12 days before the date of the conference. Your check needs to be cleared before your registration is confirmed. A letter of confirmation (along with an electronic event pass) will be e-mailed to you once payment is received. Payments to be made in full. Post-dated checks shall not be accepted.

Customer Support: +1-416-915-4458
Email: info@webinarcompliance.com

Attendance Confirmation and required documents:

After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the event venue.

Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately at the venue. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.

Cancellation & Refund Policy:

Written cancellations through 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 – minus a $300 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 (before the seminar) a credit for the amount paid minus administration fees ($300) could be transferred to any future Compliance Trainings event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

Compliance Trainings reserves the right to change/modify some topics, material or speakers/instructors without notice.

If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Compliance Trainings reserves the right to change event/seminar dates, venues or cancel altogether. Registrants will be notified by Compliance Trainings in writing as soon as possible.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

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