ComplianceOnline

Good Deviation Practice: What You Need to Know

Instructor: John R Godshalk
Product ID: 705293
  • 7
  • July 2017
    Friday
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 60 Min

Live Online Training
July 07, Friday 10:00 AM PDT | 01:00 PM EDT | Duration: 60 Min

$179.00
One Dial-in One Attendee
$479.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Get CD free on purchase of Group ticket

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD

$329.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$329.00

Live + Training CD

$379.00

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations.

Why Should You Attend:

This webinar will explore and evaluate the deviation and CAPA process. Examples are given to demonstrate the best way to handle deviations and subsequent CAPAs. Attendees will have the opportunity to interact and ask questions about best practices regarding both deviations and the CAPA process. Reasons for having a robust deviation process are given with examples.

Areas Covered in the Webinar:

  • Typical deviation and CAPA processes within the quality system
  • Best practices for the deviation and CAPA processes
  • Best practices for documentation
  • Tips on how to avoid possible pitfalls with deviations
  • Tips on minimizing regulatory scrutiny with deviations
  • Examples of good deviation write-ups, investigations and CAPAs

Who Will Benefit:

  • Compliance Manager
  • Process Engineer
  • Production Manager
  • Regulatory Manager
  • Quality Manager
Instructor Profile:
John R Godshalk

John R Godshalk
Senior Consultant, Biologics Consulting Group

John R. Godshalk, B.S., MBA, is a Senior Consultant with the Biologics Consulting Group, Inc.

During his tenure at DMPQ, John gained experience with products that include drugs, drug/device combination products, viral and bacterial vaccines, recombinant therapeutic and fractionation products, in vitro diagnostic test kits, and 510K medical devices. His inspection experience includes leading inspections of active pharmaceutical ingredient manufacturers, aseptic filling and finishing facilities, and contract manufacturers. He has performed numerous pre-approval and pre-licensing inspections for biological and biotechnology products. In addition, he has evaluated industry responses both for technical and regulatory merit during FDA regulatory compliance actions, and has assessed these responses and offered alternative solutions to resolve technical issues and regulatory concerns.

John has developed and given training programs for the FDA and regulated industry on pharmaceutical water, processing and instrumentation, lyophilization, cleaning methods and validation, and facilities for cell and gene therapy. He contributed to formulation of FDA policy as a member of the committee writing the Guidance Document for the Facilities and Controls for Cellular and Gene Therapy Product Manufacturing Operations.

John has served as chair in the review of the Chemistry Manufacturing and Controls (CMC) sections of Biologics License Applications and Supplements for both novel and licensed biological products at CBER. He has trained CBER staff on the scientific and regulatory review and evaluation of these applications and supplements.

Prior to joining FDA, John was a research engineer in industrial biotech. He also used his business experience and MBA as a consultant in the areas of business planning, marketing, information technology and strategic planning, financial modeling and analysis, budgeting, business process engineering, project management, and management consulting.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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