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Corrective And Preventive Action In Regulated Industry - NEW ISO13485:2016 UPDATE INCLUDED

Tuesday September 26, 2017 | Toronto, Canada


The objective of this one-day course is to provide the tools needed to develop and implement a compliant and effective CAPA system, from clear understanding of regulatory requirements to accurate root cause determination to confirmation of CAPA effectiveness.



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Jeff Kasoff, RAC, CMQ/OE


Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS in 1996, his Manager of Quality and Organizational Excellence certification from ASQ in 2013, and his Lean Black Belt from IIE in 2014.


Tuesday September 26, 2017
8:30 AM – 09:00 AM
Registration and continental breakfast
09:00 AM - 10:30 AM
Understanding CAPA :
  • Review of Regulations
  • Definitions
  • Where/When is CAPA Required
10:30 AM - 10:45 AM
Mid-morning Refreshment Break
10:45 AM - 12:15 PM
Elements of a Corrective Action Program :
  • Essential SOPs and Other Documentation
  • Definition and detection of nonconformance
  • Performance of Investigation
  • Review of Investigation
  • Determination of Corrective/Preventive Action
  • Performance of Corrective Action
  • Implementation of Corrective Action
  • Best Methods for Effectiveness of Corrective Action
  • Common Misconceptions
12:15 PM - 01:15 PM
Networking Lunch
01:15 PM - 02:45 PM
Root Cause Investigation
Sources of, and Application of, CAPA
02:45 PM - 03:00 PM
Mid-Afternoon Refreshment Break
03:00 PM - 04:00 PM
How FDA Trains its Investigators to Review CAPA, and Recommended Compliance Methods
Fun and Games with CAPA: A Mini-Workshop
04:00 PM
Q&A – Conclusion
Who will benefit:

This one day course will provide valuable assistance to all regulated companies that want to stay ahead of the >40% of total citations issued by FDA during 2015 on CAPA deficiencies. The employees who will benefit include:

  • Regulatory management
  • QA management
  • R&D management
  • Quality system auditors
  • Supply chain management
  • Executive management
Registration Fee & Discounts
Early Bird: Till August 25, 2017 $388.00 + HST CAD
Regular Price: August 26, 2017 to September 26, 2017 $488.00 + HST CAD
Academia / Government (At all time) $288 +HST CAD

Group Registration Discount

Special group rates available for 3 or more registrants. Some restrictions apply. For more details please contact us: By email: enquiry@ipacanada.com or Call: 416-410-7402

Registration Fee Includes:

The fee is payable in advance and includes continental breakfast, lunch & refreshments, course material and certificate of attendance.

Cancellation Policy

Cancellations received in writing more than 3 weeks before the event will be subject to a service charge of $150.00 CAD. The full conference fees remain payable if cancellations are received less than 3 weeks prior to the event. Substitutions are welcome at any time. It may be necessary for reasons beyond the control of the organizer to alter the timing of the program or the identity of the speakers. In the unfortunate event that an event is cancelled IPA are not liable for any costs incurred by delegates in connection with their attendance.


Course Venue and Hotel Accommodation
AAPS
Course Venue: AAPS Pharmaceutical Training Center
200 Consumers Road, Suite 200, North York, Ontario, M2J 4R4 Canada
Telephone: 416-502-AAPS (2277)
Direction
Recommended nearby Hotel Accommodation
Delta Hotels by Marriott Toronto East
2035 Kennedy Road Toronto Ontario M1T 3G2 Canada
Hotel Front Desk: 1-416-299-1500
Guests are responsible for their own accommodations. Please call the hotel directly.

WHO WE ARE

IPA is the premier Canadian provider of training and skill development seminars, conferences, and expositions for professionals engaged in pharmaceutical, biotechnology, medical device, natural health products, cosmetics, and Allied industries.

GET IN TOUCH

IPA
Tel: (416) 410-7402
Email: enquiry@ipacanada.com

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