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2-day In-person Seminar:
Knowledge, a Way Forward…
The A to Z's of Writing and Enforcing Effective SOPs
Los Angeles, CA
July 28th & 29th, 2016
9:00 AM to 6:00 PM
David R Dills
Regulatory Affairs & Compliance Consultant,
(Without Stay) Price: $1,295.00
(Seminar for One Delegate)
(With Stay) Price: $1,695.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
**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-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
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
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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
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toll free +1-800-447-9407 for the wire transfer
information
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4
2-day In-person Seminar:
The A to Z's of Writing and Enforcing Effective SOPs

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Writing enforcing-effective-so ps-los-angeles

  • 1. 2-day In-person Seminar: Knowledge, a Way Forward… The A to Z's of Writing and Enforcing Effective SOPs Los Angeles, CA July 28th & 29th, 2016 9:00 AM to 6:00 PM David R Dills Regulatory Affairs & Compliance Consultant, (Without Stay) Price: $1,295.00 (Seminar for One Delegate) (With Stay) Price: $1,695.00 (Seminar for One Delegate) Register now and save $200. (Early Bird) **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