Northern Reflections

Canadian Chapter of the Society of Quality Assurance
Northern Reflections
2011 Volume 1
Newsletter Date March 2011
Message from the President - It’s Up to You!
Inside this issue:
Meet your Board
2
CCSQA Poster
3
CCSQA Website
3
Regulatory News
4
Recent Warning Letters
5
CCSQA Meeting
6
CCSQA Meeting Pics
7
What's New at
Health Canada???
9
Other Tidbit News
10
Classifieds
11
Special points of interest:
•
Annual Meeting
Summary from the
CCSQA
•
CCSQA Website redesign
•
Photos of your CCSQA
colleagues and Board
•
What's New At Health
Canada
Dear CCSQA/FCSQA members.
I would like to take this opportunity to thank the Board
Members of 2010 for their continued involvement and contributions to our Society. Last
year one of the Chapter’s major achievements was the
launching of its new website.
This achievement would not
have been made possible without the dedicated efforts of
Marilla Owens and
Allison
Travis from the SQA, thank
you both on behalf of the
Board. I hope everyone has
had an opportunity to explore
its contents- any comments or
suggestions are always welcome, as only through your
feedback can we continue to
evolve our Society to be a resource for all its members and
meet everyone’s expectations.
This year, part of our mandate
will be to continue to improve
the website’s contents and
features. In fact, this year’s
Board Meeting topics have
been focused on continued
web application developments for our members. One
of these resources is the
launching of the discussion
forum where we encourage all
our members to partake in
sharing their industry
knowledge or posting queries
to engage in discussions
among other industry professionals.
Our monthly Board Meetings
will continue to be aimed at
meeting the needs of all the
variety of knowledge and
experience that exists within
the membership of our Society.
Our international perspective
as members of this Society is
even more crucial following
the establishment of the GLP
Monitoring Authority in Canada, and our colleagues from
across the country will look
upon the expertise of professionals part of our Society
for guidance. Clearly, the
most vital link in this chain
is its members, and that is
why we strongly encourage
everyone to contribute in
whatever way you can- be it
by raising a hot topic in the
discussion forum, writing a
newsletter article, presenting at our annual conference, referring your colleagues to become members,
or providing us with any
feedback on how we can
meet your needs.
It is only through the active
participation of all our
members that we will be
able to provide the most
useful, current and insightful information– it’s up to
you! I look forward to dedicating my efforts to meet
these challenges this coming
year with the rest of the
2011 Board Members.
Robert Di Lonardo
President
Page 2
Northern Reflections
Meet your SCSQA/CCSQA Board
Robert DiLonardo:
Vacant
President
Vice-President
Project Manager
Safety Manager,
Safety and Risk
Management, Pfizer Canada, Kirkland Quebec. 15 years of QA and
regulatory experience in GLP,
GCLP, GCP and Pharmacovigilence.
Charles River Laboratories
Preclinical Services Montreal.
Over 5 years experience in Quality
Assurance.
Irina Mosesova:
Secretary
Azadeh Abedian:
Treasurer
Senior Quality Assurance Inspector,
Charles River Laboratories Preclinical
Services Montreal.
Montreal, Quebec.
Four years experience in FDA and
OECD GLPs and in computer system
validations.
Joanne (Joe) Tyas:
19 years in Pre-Clinical and Pharma
industries including 12 years of QA
experience in GLP and GMP regulations.
Sami Bassil: Director
Director
Director Quality Assurance, ITR Laboratories Canada Inc., Baie d Urfé,
Quebec.
17 years of Quality Assurance experience specializing in GLP.
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Janine Johnson: Past
President
Senior Quality Assurance Inspector,
Charles River Laboratories Preclinical
Services Montreal.
3 years in Quality Assurance specializing in GLP regulations.
Tanja McAulay:
Director
Quality Assurance and Systems Manager, CIRION Biopharma Research,
Laval Quebec. 13 years of Quality
Assurance specializing in GLP, GCP
and GCLP.
Vacant
Director
Page 3
Northern Reflections
FCSQA/CCSQA Website Has been Redesigned for You!!!
The CCSQA board is happy to report the website is up and running and we welcome
you one and all to take a look at all the new website has to offer you.
The website has a fresh look and has been updated with all the latest contact info,
links, and hot topics that are of interest to all CCSQA and Canadian Quality professionals.
Upcoming changes for this website are that there will be a members only section for
specific CCSQA topics, regulatory links, and news that impact all the regulated community. This section will allow members to discuss issues of interest, post their resumes, connect with fellow CCSQA members, and more
There is
nothing so
strong or safe
in an emergency of life
as the simple
truth...
Charles
Dickens
This website has been developed with close collaboration of the SQA colleagues.
The general public will also have access to useful regulatory links, information about
the chapter, membership applications, upcoming events, and our past newsletters. In
addition, we will encourage companies to post their current job openings in quality
and regulatory affairs.
If you have any suggestions for the CCSQA website please contact us at websitecontent@ccsqa.com.
CHECK IT OUT AT WWW.CCSQA.ORG TODAY!!!!
CCSQA Poster Presentation at the SQA Annual Meeting!
The CCSQA’s mission is to actively represent current Canadian topics of interest,
and this year we are proud to report that Miss Joanne Tyas will be representing the
CCSQA at the annual meeting in Houston Texas. The annual meeting will
take place from March 27 to April. Joanne will be presenting a poster on
the GLP Monitoring Authority in Canada. This issue is relevant to all Ca!
nadian testing sites and facilities that perform, or support studies in comit
ss
i
pliance
with GLP (Good Laboratory Practices).
!
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Come and meet Joanne for a poster discussion on this hot topic.
r
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Also the CCSQA is proud to present a special event peripheral meeting and
breakfast on Wednesday March 30th from 7:00 am to 8:30 am. Breakfast
will be provided.
This is a perfect opportunity for you to network with your Canadian colleagues, or other colleagues from other countries to discuss topics relevant
to Canadian regulatory requirements.
2011 Volume 1
Page 4
Regulatory News
EPA
The EPA has made a public listing of all laboratories and companies that have
been inspected for GLP compliance by this agency. The entire listing may be
found by following this link:
http://www.epa.gov/compliance/monitoring/programs/fifra/glpinspections.html
According to the EPA website, this agency conducts inspections according to
the following requirements:
EPA conducts inspections as part of its GLP program:
•to monitor compliance with the regulations
•to assure that studies submitted to the Agency in support of a pesticide registration or under a testing consent agreement for an industrial chemical were
done with integrity, are of good quality and valid.
FDA
The FDA has issued the following draft guidance for the analysis and validation
of Immunogenicity. This provides a framework for the FDA expectations in
Immunogenicity testing and acceptance criteria where previously none were
available from the FDA. The guidance is entitled : “Guidance for Industry:
Assay Development for Immunogenicity Testing of Therapeutic Proteins”. One
major change in this guidance is that the FDA is recommending the Titre approach to reporting sample results as opposed to concentration values.
The guidance may be downloaded by following this link:
http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM192750.pdf
The difference between a successful
person and others
is not a lack of
strength, not a lack
of knowledge, but
rather a lack of
will.
Vince Lombardi
The US Food and Drug Administration is joining the Pharmaceutical Inspection
Convention (PIC) and the Pharmaceutical Inspection Cooperation Scheme (PIC
Scheme), known as PIC/S, in order to “enable the exchange of inspection reports
and other inspection information with regulatory authorities,” (former FDA
Commissioner Andrew C. von Eschenbach).
On 25 January 2011 the FDA published the final version to revise their old
Guideline on Process Validation from 1987.
http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf
Page 5
Northern Reflections
Recent Warning Letters of Interest
The FDA has recently issued the
following warning letter on August 24, 2010. This warning letter had the following topics of
interest and deficiencies:
Equipment was not adequately
maintained and documented.
Test Facility Management was
targeted as not offering the study
director and personnel adequate
resources and training on how to
prepare final reports.
Corrections to reports were not
done in the form of an amendment.
The final reports were signed
with draft contributing scientists
reports.
Test facility Management failed
to ensure that test article mixtures were tested for stability.
Test Facility Management failed
to assure that SOPs were available for all activities (specifically
for dose solution preparations).
The study director failed to follow GLPs. Specifically, control
samples were not used to accept
batches, batches were accepted
that should have been rejected,
and the method validated was
not suitable for use.
Quality Assurance did not maintain an adequate master schedule.
Quality Assurance did not ensure
that all deviations were reported.
The study director did not sign and
date the final report (some reports
were not signed for 3-5 years).
The complete warning letter may
be found by downloading the document at the following link. It is
always interesting reading and a
great learning tool, to see how the
FDA is enforcing the GLP regulations.
http://www.fda.gov/ICECI/
EnforcementActions/
WarningLetters/ucm222775.htm
This letter has caused quite a bit of
discussion in the industry regarding draft contributing reports.
The SQA has subsequently responded to the FDA with a comment letter specific to this issue.
The comments were signed by the
president of the SQA (James
McCormick) and the letter was
dated October 8, 2010. The complete response letter can be downloaded on the SQA website in the
members only section.
If you tell the
truth, then you
don't have to remember anything!!!
Mark Twain
2011 Volume 1
Page 6
CCSQA ANNUAL MEETING ROUNDUP
On 17 November 2010 the Canadian Chapter of Quality Assurance held their 8th Annual
Meeting at the Holiday Inn Hotel in Pointe Claire. This year’s
meeting was a smaller affair being a half day meeting; however, this did not prevent it being
a successful meeting with a variety of interesting topics covering a variety of the GXPs.
for the inspection through to
the inspection close out and to
the corrective and preventative
action process (CAPA) after the
inspection.
Janine encouraged audience
participation during her presentation and many of the attendees were willing to participate and share their own inspection experiences.
Our own Janine Johnson, President of the CCSQA, opened the
meeting and gave the first
presentation to the attendees.
Her presentation was titled
“You are Being Inspected….Now what?” Janine’s
presentation went over the various steps involved in a regulatory authority inspection from
preparing
The second speaker of the afternoon was Marianne Vanderwel
who gave a presentation titled
“Update on Human Subject
Protection in Canada and the
US”. Marianne explained that
there are currently various activities in Canada and the US
that have taken place or are
underway that impact human
subject protection on clinical
trials.
Paul’s presentation included
topics such as the differences of
GLP application among OECD
countries, recent regulatory
actions by the US FDA, analytical method guidance incurred sample reanalysis (ISR),
Good Clinical Laboratory Practice (GCLP) and technological
challenges and GLP application in the future. One poignant item raised by Paul during
his presentation was that even
though there may be certain
challenges with
the global implementation of
the GLPs and from technological advances, as QA professionals we should not lose site of
the reason why the GLPs exists.
The formal presentations were
completed around 5pm and the
meeting then moved on with
the Networking Reception
where hot canapés and refreshments were served.
Some of the activities described
by Marianne were concerned
with the ethical conduct of research involving humans, the
reporting of adverse events and
unanticipated problems during
clinical trials, and the registration and requirements for Institutional Review Board’s (IRBs).
Marianne’s presentation was
very informative and included
references to relevant documents. In addition her use of jocular material concerning acronyms gave the presentation a
light hearted note.
The third and final speaker of
the day was Paul Sidney whose
presentation was titled “Current
Issues and Challenges in Global
Application of GLP Regulations/
Principles”.
This gave the opportunity for
the attendees to get together on
a more informal basis.
The CCSQA Board would like to
thank the speakers and the
members who attended the
meeting for making the CCSQA
8th Annual meeting such a success and a special thanks to Janine for her hard work in making the preparations for the
meeting.
We hope to see you all at the
next meeting in 2011.
Page 7
Northern Reflections
CCSQA ANNUAL MEETING PHOTOS
Check out the photos of the last CCSQA annual meeting. A great time was had by all!
2011 Volume 1
More Photos of your CCSQA Colleages at the CCSQA Annual Meeting
Page 8
Page 9
Northern Reflections
What's New At Health Canada???
Proposition of new Tobacco Products Labelling Regulations
Health Canada has expressed a need to
change the cover of the
tobacco and little cigars
packages by proposing
replacement of the current labelling requirements with a new Tobacco Products Labelling
Regulations (Cigarettes
and Little Cigars). In
addition to requiring
the label to contain new
easy-to-understand information such as 4
Funding to Support New
Family Medicine Positions and Training Opportunities across Canada
According to the announcement released on
February
23,
2011 federal government will be allocating
funding of $39.5 million
to support more than
100 family medicine residents and provide medical services in selected
remote and rural communities accross Canada.
According to the
Health Canada website
the break-down of the
funding will take place
facturers and importers.
The analysts report
that estimated benefits
of this proposed Regulation would range between $4 and $12 billion over the same time
period. These numbers
were calculated based
on the reduction in
morbidity and mortality effects on smokers
who successfully quit,
as well as reduction in
exposure to secondhand smoke, reduction
of loss of life and damage from the cigaretteinduced fires, and gen-
eral improvement in
quality of life of former
smokers.
according to province of certain mixtures did
(see next page):
not have to be listed on
the label. The amendGovernment Strengthment to the Food and
ens Food Allergen LaDrug Regulations is
belling Regulations
more strict and will reOn February 14 2011, quire manufacturers to
Health Canada an- list the source of a food
nounced changes to allergen or gluten be
Canada’s labelling of shown on the most prefood Regulation. Specif- packaged products. In
ically, as of August 4 addition,
easy-to2012 all food labels will understand terminology
contain additional in- will be used to assist
formation in clear lan- consumers in choosing
guage with declaration the product that is safe
of all allergens, gluten for them.
sources, and sulphites.
tions outways the cost
with net positive of
$69.3 million over 10
year period, taken into
consideration the reduced costs to the
health care system
and improved quality
of life for individuals
with allergies and
their families.
toxic emission statements, 16 new health
warnings, and 8 health
information messages,
the proposal also includes a pan-Canadian
toll-free quit-line number and cessation web
site address.
It's been reported that
the cost of the proposed
regulations would range
between approximately
$74 and $83 million
over the 10-year period
of which between $50
and $53 million will be
absorbed by cigarette
and little cigar manu-
Cost-benefit statement
Given present Regula- reports that the benefit
tions some of the ingre- of implementation of
dients and components the new labeling regula-
The proposed Regulation could be found at
the following link:
http://
www.gazette.gc.ca/rppr/p1/2011/2011-02-19/
html/reg3-eng.html
Sources:http://www.hc
-sc.gc.ca/hc-ps/consult/
_2011/label-etiquet/
index-eng.php
http://
www.gazette.gc.ca/rppr/p1/2011/2011-02-19/
html/reg3-eng.html
Source: http://www.hc
-sc.gc.ca/fn-an/labeletiquet/allergen/
project_1220_rias_eeir
-eng.php
http://www.hcsc.gc.ca/ahc-asc/
media/nr-cp/
_2011/2011_23eng.php
2011 Volume 1
Page 10
Breakdown of Funding for New Medical Positions and Training in Canada
Ontario
$11 million
60 additional training positions in emergency medicine or enhanced skills
Nunavit
$4.9 million
8 additional family medicine recidencies
Manitoba
$6.9 million
15 additional family medicine residents and expanding its Northern Family Medicine Residency Program
British Columbia
$5.9 million
20 additional residencies assigned throughout the
Province
Newfoundland and
Labrador
$4.5 million
16 additional family medicine residents
New Brunswick
$2.8 million
6 additional residencies with enhanced training in
emergency and acute care
Saskatchewan
$3.4 million
6 additional residencies with enhanced training in
anaesthesia or surgery
Other Tidbit News
The SQA announced that they have initiated a
rapid response team to provide comments to the
FDA request for the upcoming revisions to the
GLP Good Laboratory Practices (GLPs), Docket No. FDA-2010-N-0548.
The Presidents of the federal research agencies
(CIHR, NSERC and SSHRC) announced in December 2010, the release of the 2nd edition of
the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, or “TCPS
2.”
The complete SQA GLP proposal for comments
can be downloaded from the SQA website For
more information on the Federal Register notice
and submission guidelines, please see
Further details can be found below:
Interagency Advisory Panel on Research Ethics
(PRE), 350 Albert Street, Ottawa, ON K1A
1H5 , Telephone: 613-996-0072 , E-mail: secretariat@pre.ethics.gc.ca
http://edocket.access.gpo.gov/2010/pdf/201031888.pdf We
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Classifieds
Advertising/Job Announcements
Advertisements are posted on our webpage http://www.ccsqa.org/. In addition, if your advertisement is posted on
the webpage at time we publish our newsletter, your advertisement will be included in the newsletter as well.
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This option allows you to pay per submission for a 30 dayperiod display on our website for $25.00 CAD.
II. Pay-period: 90 days
This option allows you to pay $60.00 CAD for 90 day-period
with the opportunity to have a replacement submission every
30 days (i.e., three (3) postings within that period).
III. Pay-period: 6 months
This option allows you to pay $100.00 CAD for 180 dayperiod with the opportunity to have a replacement submission
every 30 days (i.e., six (6) postings within that period).
IV. Pay-period: 1 year
This option allows you to pay $200.00 CAD for a 1 year subscription with the opportunity to have a replacement submission every 30 days (i.e., twelve (12) postings).
FORMAT REQUIREMENTS
Microsoft Word™ file format (file will be converted to PDF prior to posting)
Images must be of High Resolution (at least 300dpi)
Submissions may be modified due to file size limitations.
Submitters will be notified and asked to approve any modifications, prior to publication.
SUBMISSION REQUIREMENTS
Complete SUBMISSION REQUEST FORM (send email to info@ccsqa.org to receive form)
Notify CCSQA of your submission request by e-mail (include request form and submission)
Mail payment and the original submission request to the CCSQA at the address on the form
The CCSQA board reserves the right to refuse a submission, based on the relevance of the content to its
membership. Submitters will receive notification by e-mail and return of payment will be accompanied with
an explanation of rationale for refusal.
PAYMENT
The above rates are for non-members. Career opportunity submissions for CCSQA members are free of charge if
the job posting is relevant to our membership (i.e., QA, regulatory). Members will receive a 10% discount on all other types of submissions (i.e., marketing). All advertising rates are NET (i.e., tax included). There is no discount for
advertising agencies or non-members to the CCSQA. Payment must be received by check or money order, made
payable to the Canadian Chapter of the Society of Quality Assurance. A 25$ surcharge will be applied to returned
checks. Submission will not be uploaded until we receive full payment, the time clock starts on the date the submission is posted on the website.