A Day with the Inspectors 2019
Upcoming

  • May 30, 2019
    8:00 am - 4:30 pm

Location

3550 Pharmacy Avenue, Toronto, Ontario, M1W 3Z3
C

Certification Areas

BACK BY POPULAR DEMAND:

PSG PROUDLY PRESENTS OUR 2nd ANNUAL EXCLUSIVE EVENT

& THIS TIME IT’S BIGGER THEN LAST YEAR!

2019 DAY WITH THE INSPECTORS!

Check out our Event Program here!

 

This single day event will help to give attendees a better understanding of Health Canada regulations, identify gap areas within their own organizations and become aware of the expectations from our Governing Body through training from an exclusive line up Health Canada Inspectors. The event will provide attendees with a rare and unique opportunity to learn directly from the Inspectors and will cover the following topics:

 

Overview & Updates from the Health Products & Licensing (HPIL) Division
Presented by: Kimby Barton- Director Health Products Inspection & Licensing (HPIL), Health Products Compliance Directorate (HPCD)
➢ The HPIL Overview and Updates presentation will provide updates on legislative and regulatory initiatives, as well as identify Policy and Guidance documents recently published, currently under consultation as well as those where work is ongoing. This will include updates on ongoing Pilots, progress on International collaboration and harmonization, opportunities for stakeholder and priorities for the upcoming year.

 

What to Expect During a GMP Inspection (Trends & Inspection Risks)
Presented by: Rosalee Scarito- Senior GMP Inspector, Central Region
➢ Providing a view to what inspectors look for during GMP inspections, both domestic and foreign, scheduled and unannounced, this talk will describe our risk-based approach to inspections to optimize time spent and ensure sites are focussing on what matters most. This will be highlighted through case studies, and a discussion of trends from recent inspections.

 

DELU Updates
Presented by: Marc-Andre Labelle- Manager of Drug Establishment Licensing Unit
➢ The DEL updates presentation will provide updates on legislative and regulatory changes, as well as changes in processes both recent and planned.

 

GMP Evidence for Foreign Building Risk Issues & Assessments
Presented by: Ann Kourtesis- A/Manager of GMP Unit HQ2
➢ This discussion will provide an overview of HPIL’s foreign building paper assessment process
with a focus on the requirements for a complete GMP evidence package. The presentation will
highlight common deficiencies noted during the screening process and will include a review of
the changes in the Health Canada guidance How to demonstrate foreign building compliance
with drug good manufacturing practices (GUI-0080) and improvements seen since the
implementation of the updated GUI-0080.

 

Health Canada Guidance Updates & Case Studies
Presented by: Anthony Lostracco- Supervisor of Drug GMP Inspection Unit, Central Region
➢ This discussion will provide an overview of HPIL’s foreign building paper assessment process
with a focus on the requirements for a complete GMP evidence package. The presentation will
highlight common deficiencies noted during the screening process, and will include a review of
the changes in the Health Canada guidance How to demonstrate foreign building compliance
with drug good manufacturing practices (GUI-0080) and improvements seen since the
implementation of the updated GUI-0080.

 

Interactive Q&A Panel Discussion
Presented by the Participating Health Canada Inspector Team
➢ Attendees are invited to ask any single question to the panel for a discussion session on various
concerning audience topics.

 

 

THIS EVENT WAS SOLD OUT LAST YEAR.

PURCHASE YOUR TICKETS EARLY TO AVOID DISAPPOINTMENT!

 

Sponsored by:

 

 



Student Ticket: $250.00 On Sale
Group 5+ Tickets: $725.00 On Sale
Basic Member Ticket: $795.00 On Sale
Pro/Pro Plus Ticket: $745.00 On Sale