This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents.

1. 2-day In-person Seminar:
Knowledge, a Way Forward…
The A to Z's of Writing and Enforcing Effective SOPs
Philadelphia, PA
May 12th & 13th, 2016
9:00 AM to 6:00 PM
David R Dills
Regulatory Affairs & Compliance Consultant,
(Without Stay) Price: $1,495.00
(Seminar for One Delegate)
(With Stay) Price: $1,895.00
(Seminar for One Delegate)
**Please note the registration will be closed 2 days
(48 Hours) prior to the date of the seminar.
Price
David R. Dills, Regulatory & Compliance Consultant
with more than 24 years of hands-on experience and a proven track
record within the FDA regulated industry, has an extensive regulatory
and compliance background with Class I/II/III and IVD devices,
pharmaceutical operations, and manages activities within the global
regulatory and compliance space. He manages quality, regulatory and
compliance projects with multiple competing priorities having a direct
impact on site operations and commercial opportunities and develops
strategies for governmental approval to introduce new products to
market, provides guidance on regulatory and compliance requirements
and prepares/reviews worldwide submissions/dossiers/technical files
and addresses global regulatory requirements.
Seminar Pricing Includes (With Stay)
Google Nexus 7 Tablet
2 Days Stay
Pick-up and Drop Facility (Nearest
Airport)
Break-Fast and Lunch
High Tea
Pack of 3 Webinars will be
provided which has been done in
the past on similar subject
Writing SOPs or procedural documents can be challenging at times.
However, writing SOPs is overall a straightforward process. However,
enforcing what you already created and implemented in the pipeline is
another story. The term SOP is very obvious. We have seen "clearly
written description of how specific tasks are to be done." Another
satisfactory definition would be "detailed written instructions that
achieve the uniformity of the performance of a specific function." Is the
firm doing what the regulations specify? Is the firm doing what their
procedures specify? If you are medical device or a pharmaceutical
manufacturer, these definitions come as no surprise because when it
comes to FDA regulations and guidance documents
Overview
Global
CompliancePanel

2. 2-day In-person Seminar:
The A to Z's of Writing and Enforcing Effective SOPs
Global
CompliancePanel
Agenda:
Day One Day Two
Lecture 1 : The SOP end user, required sections and best
practices for SOP development
Lecture 2 : Tips that help and work when you need to
create, clear, concise procedures
Lecture 3 : Improve your writing skills
Lecture 4 : Development and formatting recommendations:
Content and Structure
Lecture 5 : Reminders that you need to know when you
critique your own procedures
Lecture 6 : FDA and overall global expectations and
requirements for SOP development,
implementation and enforcement
Lecture 7 : Create SOPs for the target audience
Lecture 8 : Provide appropriate level of details and use
writing conventions
Lecture 9 : Have increased confidence in planning and
writing your SOPs
Lecture 10: Understand the industry standards for
procedure writing, including typical
components of documents, and using
document templates
Lecture 1 : Understand the full life cycle of SOPs
Lecture 2 : Understand how training is integral to
document approval
Lecture 3 : Control, archival and disposal
Lecture 4 : Identify ways to avoid or reduce risk of
regulatory compliance through better writing
of your procedures.
Lecture 5 : Use various tools such as flowcharting to
define a logical procedure
Lecture 6 : Write a concise, unambiguous SOP for its
intended purpose and stay on-point and on-
message
Lecture 7 : Ensure the document is written for the
correct audience
Lecture 8 : Link SOPs to good documentation practices
Lecture 9 : Define clear responsibilities, roles and goals
for personnel involved in SOP development

3. Global
CompliancePanel
www.globalcompliancepanel.com
Kindly get in touch with us for any help or
information.
Look forward to meeting you at the seminar
GlobalCompliancePanel
What You will get
Special price on future seminars by
GlobalCompliancePanel.
Networking with industry's top notch professionals
7
9
1 Learning Objectives
2 Participation certificates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
based trainings.
Special price on future consulting or expertise
services.
3
4
5
6
Seminar Kit – includes presentation handout,
ID card, brochure, trainings catalog, notepad
and pen.
8
Contact Information: Event Coordinator
NetZealous LLC, DBA GlobalCompliancePanel
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
Toll free: +1-800-447-9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
10%
20%
25%
30%
2 Attendees to get offer
3 to 6 Attendees to get offer
7 to 10 Attendees to get offer
10+ Attendees to get offer
Group Participation
Payment Option
1 Credit Card: Use the Link to make Payment by
Visa/Master/American Express card click on the
register now link
2 Check: Kindly make the check payable to
NetZealous DBA GlobalCompliancePanel and
mailed to 161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
PO: Please drop an email to
support@globalcompliancepanel.com or call the
our toll free +1-800-447-9407 for the invoice and
you may fax the PO to 302 288 6884
Wire Transfer: Please drop an email to
support@globalcompliancepanel.com or call our
toll free +1-800-447-9407 for the wire transfer
information
3
4
2-day In-person Seminar:
The A to Z's of Writing and Enforcing Effective SOPs