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Leadership! - In the Non-Leadership Position - Webinar By GlobalCompliancePanel

About this event

Web site…
7 Dec 2011
Online Training, Wilmington | DE | Zip 19801, United States
Contact address
webinars web
online training
Suite 1200
United States

This webinar will provide valuable guidance to personnel in regulated companies who are in roles viewed as merely support to those in formal leadership positions.

Keys to develop credibility. Become a "go to" resource. Break out of the typical staff support mind set and reduce frustration. Play a more proactive role in product development, process implementation, project management planning, and corporate culture change. Enhance existing responsibilities in regulatory compliance, audit response, proof of cGMP "progress against plan", and other regulated activities requiring a planned documented rationale. Common tools for increased credibility will be discussed. Simple approaches using common Excel- or Word-type PC applications programs that can be used immediately are presented. Regular use of a few simple but powerful tools to virtually eliminate "fire fighting" and bring you new credibility. Contribute greatly to your company's reduction of scheduling uncertainty, incomplete projects when time is running out, increased product liability, while assisting in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.

Why should you attend: The U.S. FDA cGMPs and the European Medicines Agency (EMA) expect QA/RA leadership at regulated companies. Production, marketing, engineering, and senior management may not agree with or be accepting of a leadership role from QA/RA. How can these differing mindsets be reconciled? Should they? What part does "incorporating" yourself play? What tools can facilitate the assumption of such a leadership role in a typically non-leadership position. Such tools can also provide the perfect response mechanism for communication with the FDA, by either RA or senior management; and the EU MDD and their notified bodies are no different. Also addressed is how to gain senior management support for this assumed role. Growing high-profile field problems indicate that QA/RA "leadership" is needed, and what's currently passed for such "leadership" is either poor or non-existant. Be a change agent for proper quality planning and execution. The credibility-building techniques discussed in this webinar are not rocket-science, but require the implementation of formal methods with documentation, and defensible rationale. Use tools / templates to bring predictability to your company's QA/RA leadership process. Use them to defend your remediation efforts with the FDA. Use them to prove "progress against plan". Then "anchor" these efforts to mitigate entropy.

Areas Covered in the Session:
Why leadership?
The Change Agent
You "Inc."
Vision and Urgency
Perceived vs. Real Power: Demands, Antidotes and Facts
Assumption, Communication, and Leadership
Short-term "Wins"
Other Techniques, Tools and Templates
Anchoring and Entropy - Last Not First
Who Will Benefit:
Senior Management in Drugs, Devices, Biologics, Dietary Supplements

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884