20 writing and enforcing effective sops

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Global

CompliancePanel

Knowledge, a Way Forward…

2-day In-person Seminar:

Writing and Enforcing Effective SOPs Chicago, IL

Price

March 29th & 30th, 2018 Price:

9:00 AM to 6:00 PM

$1,295.00

(Seminar for One Delegate)

Register now and save $200. (Early Bird)

David R Dills Register for 5 attendees

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

Price: $3,885.00 $6,475.00

You Save: $2,590.0 (40%)*

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

Register for 10 attendees

Price: $7,122.00 You Save: $5,828.0 (45%)* $12,950.00

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.

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 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

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.


2-day In-person Seminar:

Global

CompliancePanel

Writing and Enforcing Effective SOPs

Agenda: Day One

Day Two

Lecture 1 : The SOP end user, required sections and best practices for SOP development

Lecture 1 : Understand the full life cycle of SOPs

Lecture 2 : Tips that help and work when you need to create, clear, concise procedures

Lecture 2 : Understand how training is integral to document approval Lecture 3 : Control, archival and disposal

Lecture 3 : Improve your writing skills Lecture 4 : Development and formatting recommendations: Content and Structure

Lecture 4 : Identify ways to avoid or reduce risk of regulatory compliance through better writing of your procedures.

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 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 onmessage

Lecture 8 : Provide appropriate level of details and use writing conventions

Lecture 7 : Ensure the document is written for the

Lecture 9 : Have increased confidence in planning and writing your SOPs

Lecture 8 : Link SOPs to good documentation practices

Lecture 10: Understand the industry standards for procedure writing, including typical components of documents, and using document templates

Lecture 9 : Define clear responsibilities, roles and goals

correct audience

for personnel involved in SOP 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%

1

Learning Objectives

2

Participation certiďŹ cates

3

Interactive sessions with the US expert

4

Post event email assistance to your queries.

5

Special price on future purchase of web

7 to 10 Attendees to get offer 10+ Attendees to get offer

Payment Option

based trainings.

1

Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link

6

Special price on future consulting or expertise services.

2

Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216,

7

GlobalCompliancePanel.

Fremont, CA 94539, USA

3

PO: Please drop an email to support@globalcompliancepanel.com or call the

4

Special price on future seminars by

8

Seminar Kit – includes presentation handout,

our toll free +1-800-447-9407 for the invoice and

ID card, brochure, trainings catalog, notepad

you may fax the PO to 302 288 6884

and pen.

Wire Transfer: Please drop an email to support@globalcompliancepanel.com or call our toll free +1-800-447-9407 for the wire transfer

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Networking with industry's top notch professionals

information

Contact Information: Event Coordinator 161 Mission Falls Lane, Suite 216,

Kindly get in touch with us for any help or information.

Fremont, CA 94539, USA

Look forward to meeting you at the seminar

NetZealous LLC, DBA GlobalCompliancePanel

Toll free: +1-800-447-9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com

www.globalcompliancepanel.com

GlobalCompliancePanel


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