2-day In-person Seminar on “The A to Z's of Writing and Enforcing Effective SOPs (Standard Operating Procedures)” at Baltimore, MD

Event Details

Time: November 21, 2013 at 9am to November 22, 2013 at 6pm
Location: Baltimore, USA
Street: Hilton Garden Inn Baltimore
City/Town: Baltimore
Website or Map: http://bit.ly/16FQwRc
Phone: 8004479407
Event Type: conference
Organized By: John Robinson
Latest Activity: Oct 10, 2013

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Event Description

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 manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, 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 firm doing what the regulations specify? Is the firm 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. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format.

Who Will Benefit:

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

Speaker Profile:

David R. Dills, Regulatory Affairs & Compliance 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 I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO.

DATE, VENUE & PRICE:

Location: Baltimore, MD | November 21st & 22nd, 2013 | 9 AM to 6 PM PDT
Venue: Hilton Garden Inn Baltimore

Address: 625 S President St, 21202 Baltimore

Price: $1295.00

Discount: Register now and save $200. (Early Bird)

Until September 25, Early Bird Price: $1,295.00

From September 26 to November 19, Regular Price: $1,495.00

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

Contact Information:
Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884

Email: support@globalcompliancepanel.com