Global

CompliancePanel

Knowledge, a Way Forward

2-day In-person Seminar:

Writing and Enforcing Eective SOPs

Price
Minneapolis, MN
(Without Stay) Price:

February 25th & 26th, 2016

9:00 AM to 6:00 PM

$1,295.00

(Seminar for One Delegate)

(With Stay) Price:

$1,695.00

(Seminar for One Delegate)

Register now and save $200. (Early Bird)

David Dills
Regulatory Affairs & Compliance Consultant,
David R. Dills, Regulatory Affairs & Compliance

**Please note the registration will be closed 2 days

(48 Hours) prior to the date of the seminar.

Consultant currently provides regulatory, compliance

and quality consultative services for medical device and
pharmaceutical/combination manufacturers, and also has an
accomplished record with more than 24 years of experience with Class

Seminar Pricing Includes (With Stay)

I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the

areas of Regulatory Affairs, Compliance and Quality Systems. He has

Google Nexus 7 Tablet

been previously employed, with increasing responsibilities by medical

2 Days Stay

device manufacturers and consultancies, including a globally

recognized CRO.

Overview
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 specic tasks are to be done." Another
satisfactory denition would be "detailed written instructions that
achieve the uniformity of the performance of a specic function." Is the
rm doing what the regulations specify? Is the rm doing what their
procedures specify? If you are medical device or a pharmaceutical
manufacturer, these denitions come as no surprise because when it
comes to FDA regulations and guidance documents "establish" means
to dene, to document (in writing or electronically) and to implement.
The goal and emphasis with FDA is simple. Proof of "Establish" is the
foundation. Is the rm doing what the regulations specify? Is the rm
doing what their procedures specify? Are the procedures being followed
and enforced by company personnel? SOPs are needed in regulated
industries to give step-by-step instructions for performing a particular
job or task.

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

2-day In-person Seminar:

Global

CompliancePanel

Writing and Enforcing Effective SOPs

Who Will Benet:

This webinar will provide valuable assistance and guidance to pharmaceutical, medical device and biotechnology
manufacturers and other rms in the life sciences industry who require a refresher session on writing and
enforcing their own SOPs and internal procedures or for those new to this area who desire to gain a better
understanding of the SOP process. The employees who will benet include basically anyone and everyone at
your organization who are required to write and/or comply with SOPs, including all levels of management and
departmental representatives and those who desire a better understanding or a "refresh" overview of the SOP
process from start to nish, including:

Regulatory Affairs
Clinical Affairs
Quality Assurance/Quality Control
Compliance
Marketing & Sales
Manufacturing and Technical Services
Engineering
IT/MIS
Executive Management

Laboratory Operations
Customer Service
Clinical Research managers and personnel
Specialists/SMEs in all departments
QA/RA managers and personnel
Quality System auditors
Distributors/Authorized Representatives
Legal Counsel
Consultants

Agenda:
Day One

Day Two

Lecture 1: The SOP end user, required sections and

Lecture 1: Understand the full life cycle of SOPs

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 condence in planning
and writing your SOPs
Lecture10: Understand the industry standards for
procedure writing, including typical

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 owcharting to
dene 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: Dene clear responsibilities, roles and

components of documents, and using

goals for personnel involved in SOP

document templates

development

2-day In-person Seminar:

Global

CompliancePanel

Writing and Enforcing Effective SOPs

What You will get

Group Participation

10%

2 Attendees to get offer

20%

3 to 6 Attendees to get offer

25%
30%

Learning Objectives

Participation certicates

Interactive sessions with the US expert

Post event email assistance to your queries.

Special price on future purchase of web

7 to 10 Attendees to get offer

10+ Attendees to get offer

Payment Option

based trainings.

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register now link

Special price on future consulting or expertise

services.

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NetZealous DBA GlobalCompliancePanel and
mailed to 161 Mission Falls Lane, Suite 216,

GlobalCompliancePanel.

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Look forward to meeting you at the seminar

NetZealous LLC, DBA GlobalCompliancePanel

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Fax: 302 288 6884
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