Summary
Corrective & Preventive Action (CAPA) systems have been in existence since the dawn of time. When a negative event occurs, one of the first questions is how and why did it happen? Depending on the impact of the event, there is an analysis or investigation of the event to determine all aspects of the "Why" and the "How". Although quite informal, this is a rudimentary CAPA system.

Details
Discount : Get 15 % Discount as a early bird registrations. Use Promo code CGO15

Sometimes, no matter how well controlled, the input of the process fails to produce the expected output. A deviation or nonconformance has occurred. A deviation is defined as a departure from the expected input, in other words, a procedure was not followed, or a specification requirement was not met. A nonconformance, according to Part 820, means the non-fulfillment of a specified requirement. This requirement, like that of a deviation, indicates a procedure was not followed or a specification requirement was not met. When deviations/nonconformities occur, a system must be in place for evaluating the impact on quality, conducting an investigation to determine root cause, and following up to verify the root cause was properly identified .A Corrective and Preventative Action(CAPA) system must be in place to track these events until closeout of the event is completed.

Medical product problems require a stringent and formal CAPA system. The original GMP regulations for devices & drugs were embedded within the regulations. CAPA systems were first formalized for devices in the "Quality Systems Regulation" and for drugs in ICH Q-10, "Pharmaceutical Quality Systems"

The principles of handling deviations and nonconformities are the same for devices and drugs. For devices, the process is well outlined in the regulations. However, for drugs, the requirements are not so defined.

Why should you attend : The FDA establishment inspection focuses on nonconformities/deviations and CAPA systems because deviations and nonconformities point toward quality system failures. You and your firm must be prepared. However, the need for a CAPA system is much more than a compliance requirement. Combined with investigations, it is one of the most useful tools for analyzing data leading to quality improvements and efficiencies.

This webinar will explore the Event-Investigation-CAPA (EIC) lifecycle and how you can apply it to your operations. This EIC lifecycle will be explained using graphics to explain regulatory requirements and industry practice, These graphics will serve as a model for establishing an effective and practical CAPA system.

By attending this webinar, you will better understand CAPA systems, learn ways to better use or improve your existing system, and begin development and implementation of a new CAPA system.

Areas Covered in the Session ( Objectives & Overview )

Good Manufacturing Practices And Quality Systems.
What do the GMP's Say About Deviations & Nonconformities and CAPA Systems?
The Importance of Master Records
Classifying Deviations and Nonconformities
Analyzing the Event (Deviation or Nonconformity)
Roles & responsibilities
The Deviation-Nonconformity and CAPA Lifecycle
Event
Discovery
Immediate Actions.
Notification of Event.
Establishing the Investigative Team (What function should take the lead?)
Data Collection.
Establishing the Root Cause
Preparing the Report and Conclusion
Approval of the Report
Close-Out & CAPA Entry
Tracking & Follow-Up.
Determining the Effectiveness.
The Next Step
8. Documentation and Record Keeping

9. What Will the Computer Do for You?

10. Review

Who will benefit : Quality Control Laboratory Manager, Warehousing, Purchasing Managers and Procurement Managers, Laboratory Analyst, Cost Accounting, IT, Documentation Management

Instructor Profile : Howard enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He derives considerable satisfaction from diagnosing quality systems in order to make them more compliant, efficient, and productive. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA. His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.

For any assistance contact us at support@compliance2go.com or call us at 877.782.4696

Do you attend local networking events as part of your business marketing strategy? Have you ever thought you should expand your professional network using online social media?

By just using only one social media website, you could be limiting your business’s opportunity to grow exponentially.

There are many useful networking sites, including LinkedIn, Biznik, Plaxo, Facebook, and even niche communities.

In this e-class, Social Networking for Business Professionals, you will learn why and how to use each one. Plan and execute an effective strategy to make each social networking site part of your marketing mix and make them work for you.

This online class will help you break through the limits of one-stop-shopping online networking.

Webinar Takes Place on June 23, 2011 from 2-4pm ET

Price includes video replay availability for 3 months

This is an “e-class” and takes place completely online. After registration you will receive an email explaining how to get into the online classroom at the date and time specified.

Register: http://www.emarketingconnection.com/SN4BP

Do you attend local networking events as part of your business marketing strategy? Have you ever thought you should expand your professional network using online social media?

By just using only one social media website, you could be limiting your business’s opportunity to grow exponentially.

There are many useful networking sites, including LinkedIn, Biznik, Plaxo, Facebook, and even niche communities.

In this e-class, Social Networking for Business Professionals, you will learn why and how to use each one. Plan and execute an effective strategy to make each social networking site part of your marketing mix and make them work for you.

This online class will help you break through the limits of one-stop-shopping online networking.

Webinar Takes Place on June 23, 2011 from 2-4pm ET

Price includes video replay availability for 3 months

This is an “e-class” and takes place completely online. After registration you will receive an email explaining how to get into the online classroom at the date and time specified.

Register: http://www.emarketingconnection.com/SN4BP

Understand why social networking sites use by employees is a concern, the potential legal risks associated with use of social networking sites for recruiting process, and how your failure to handle a social networking problem can lead to other legal problems.

Description
Why Should You Attend:
Social networking has literally exploded over the past few years. Names such as MySpace, LinkedIn, Facebook, Twitter, and many others are becoming common household names. Many companies encourage their employees to use such sites to increase the employees’ networking community. Many companies are finding, however, that employees may say too much on social networking sites – like criticizing a supervisor, engaging in on-line bullying of a co-worker, disclosing a trade secret, etc.

Can you or should you discipline? Courts and regulatory agencies are just beginning to address these important issues. The National Labour Relations Board has agreed to consider whether an employer appropriately terminated an employee for criticizing her supervisor on Facebook. On the other hand, can you use such sites for your own purposes like checking out an applicant’s profile to see if there are any discrepancies in the resume the applicant submitted to your company? Attend this webinar to understand what are the legal issues that can come up if the social networking problem is not handled properly, what the regulatory agencies are saying about it. How to write a policy addressing this problem.

Areas Covered in the Seminar:

What is social networking and why is it an employment/labor law issue?
How your use of social networking in the recruiting process can lead to a discrimination lawsuit.
Why your employees’ use of social networking – both on and off duty is a human resource concern.
How your handling of a social networking problem can lead to a discrimination claim.
How your failure to handle a social networking problem can lead to other legal problems such as potential violations of HIPAA, an harassment claim, or even a violation of SEC regulations.
What the NLRB is saying about employees’ social networking.
How to write a policy addressing social networking concerns.
Who Will Benefit:

All companies – both private and governmental – will benefit from this webinar. Every company with employees will find at some point that it will have a problem that arises from an employee’s use of social networking sites.
HR Managers
Supervisors
Labor department
Employee Relations department
Management
Instructor Profile:
Susan Fahey Desmond, has been representing management in all areas of labor and employment law since her graduation from the University Of Tennessee School Of Law since 1985. She is listed in Best Lawyers in America for Labor and Employment Law and has been named by Chambers USA as one of America’s leading business lawyers in Labor and Employment Law. She is also listed in Mid-South Super Lawyers.

Susan Fahey Desmond is a shareholder in the Firm's Labor and Employment Practice Group and works from the firm’s Gulf Coast office. She is a graduate of the University of Mississippi (B.A., 1982) and the University Of Tennessee School Of Law (J.D., 1985). Ms. Desmond is a member of the Mississippi, Louisiana, Texas, Florida and Colorado Bar Associations. She is also a member of the Federal and American (member, Labor and Employment Law Section; past chair, Labor Committee; Executive Council Coordinator, Young Lawyers Section; member, Torts and Insurance Practice Section; member, Emerging Issues Committee) Bar Associations. Ms. Desmond has served as a director for both The Mississippi Bar Young Lawyers Division and the Jackson Young Lawyers Association.
She is a former secretary of the Mississippi Women's Lawyers Association. Ms. Desmond was named the 1997-98 Outstanding Young Lawyer in Mississippi and is listed in The Best Lawyers in America, MidSouth Super Lawyers, and Chambers USA: America's Leading Business Lawyers, Labor and Employment Law sections.

Why Should You Attend:

Social networking has literally exploded over the past few years. Names such as MySpace, LinkedIn, Facebook, Twitter, and many others are becoming common household names. Many companies encourage their employees to use such sites to increase the employees’ networking community. Many companies are finding, however, that employees may say too much on social networking sites – like criticizing a supervisor, engaging in on-line bullying of a co-worker, disclosing a trade secret, etc.

Can you or should you discipline? Courts and regulatory agencies are just beginning to address these important issues. The National Labour Relations Board has agreed to consider whether an employer appropriately terminated an employee for criticizing her supervisor on Facebook. On the other hand, can you use such sites for your own purposes like checking out an applicant’s profile to see if there are any discrepancies in the resume the applicant submitted to your company? Attend this webinar to understand what are the legal issues that can come up if the social networking problem is not handled properly, what the regulatory agencies are saying about it. How to write a policy addressing this problem.

NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.

Join Andrea Vahl and B. Hopkins on June 24th at 1:00PM Mountain Time (3:00PM Eastern) on this Webinar where they will discuss some of the more powerful Twitter strategies in getting your product and service in front of your target market on twitter.

Webinar attendees will learn:

* How to build an engaged Twitter following
* Twitter best practices
* Tracking your Twitter ROI
o (Knowing how to do this will keep you from wasting hours of useless tweeting)
* Creating buzz for your Twitter event.
* What do you Tweet about

As an added bonus, the first 50 registrants will receive:

* Social Networking Exposed! - Ebook on Social Media

LinkedIn for Job Search Basics Webinar July 16: An $80 Value for Only $35!

To introduce our Webinar series, we're offering a drastic discount on our LinkedIn for Job Search Basics Webinar.

Thursday, July 16 at 2 pm Central time, attend this one-hour Webinar and learn:

* How Employers Use LinkedIn
* Must Have Elements of Your Profile
* Making and Getting Recommendations
* Becoming Findable
* Building Your Personal Brand
* Using LinkedIn Groups
* Power Tools to Enhance LinkedIn

Use of Online Social Networking sites like LinkedIn was ranked by recent hires as the #1 job-getting strategy, beating in-person networking by a wide margin!

What attendees of previous Linked InSolutions Webinars have to say:

-"Thanks for the engaging webinar on LinkedIn! I learned a great deal and took a great deal away from the webinar."
- "The session was wonderful. I thank you for all the information. It was very helpful! "
- "I've seen a few other presentations about LinkedIn and I got the most out of yours. I had not heard the terms "LION" or "IDK" before. That info was interesting and helpful."

Sign up now:

https://www2.gotomeeting.com/register/539100291

And then pay here:

http://linkedinbasicsjuly16.eventbrite.com/

More information at http://www.linkedinsolutions.com!

See our flyer at http://www.linkedinsolutions.com/images/linkedin%20for%20job%20search%20...

If you’ve signed up for a couple of social networking sites but feel overwhelmed or you’ve been thinking about it, but haven’t taken the next step, this webinar will shorten your learning curve and have you networking in less than an hour. During the session, we will cover the process from creating your profile to building your social network. At the conclusion of the webinar, you will be successfully on your way to networking.

During this webinar session, you will learn:

-- How to get started on the big three: Twitter, LinkedIn and Facebook
-- The secrets to a successful online profile
-- Simple ways to build your social network
-- Social networking mistakes to avoid
-- Time-saving tips

Reserve your Webinar seat now: http://www.socialnetworkingandyou.com/social-networking-quick-start/

Sign up for the Webinar or classroom sessions before May 14 to save $10!

LinkedIn or Left Out?
Power Workshop on Using Social Networking to Get a Job
How to Maximize Your Use of Facebook, LinkedIn,
and Twitter to Stand Out in the Crowd

Heard the buzz about online social networks like LinkedIn, Twitter and Facebook?

Did you know many people are using them to get jobs? Yes, even Facebook!

Online Social Networking was ranked by recent hires as the #1 job-getting strategy, beating in-person networking by a wide margin!

Attend this Power Workshop and learn how you can use Web-based social networks to build professional relationships – even if you don’t know the first thing about them – and learn how to use these relationships to find your next job.

* Each Power Workshop session is limited to 25 attendees to enable personal attention

* Not in the Twin Cities? Attend the simultaneous Virtual Power Session over the Web - unlimited number can attend

Classroom rate: $125
Webinar rate: $65

We have two upcoming sessions at 2 pm and 5:30 pm on Thursday, May 28th. Sessions are held at:

The Commerce Building, 2nd Floor Conference Room
8200 Humboldt Avenue So.
Bloomington, MN 55431
Located near the junction of 494 and 35W

Go in the West entrance and take the elevator to the second floor

Sign up at www.linkedinsolutions.com!

Businesses now have the power to leverage the Internet - search engines, blogs, social media - to reach customers more effectively. This includes connecting with customers where they hang out online and engaging in conversations about the topics most important to them. Social CRM (Customer Relationship Management) is all about joining the ongoing conversations our customers and prospects are already having and not trying to control them. It's realizing that people like doing business with people they like and love doing business with people they trust.

This free webinar will cover:

* How to use social media to connect with customers online

* Creating content to attract more customers to your business

* Tools to help you manage and measure your social media efforts