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Main Leadership! - In the Non-Leadership Position

Leadership! - In the Non-Leadership Position Instructor : John E Lincoln

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Product Id :  600607

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

Training Options

Duration: 90 Minutes  

support@globalcompliancepanel.com

Wednesday, December 7, 2011 Overview: 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.

10:00 AM PST | 01:00 PM EST

b Live live online training only for one participant c d e f g Price: $245.00

c Corporate Live 2 to 5 participants from a single d e f g

Webinar Packs

location (For multiple locations contact Customer Care) Price: $495.00

c Corporate Live 6 to 10 participants from a single d e f g

Pack of THREE: Best Selling Webinars by GlobalCompliancePanel Price: $495.00

Care)

Pack of THREE: Best Selling DHFDMR-DHR Webinars by GlobalCompliancePanel

Price: $995.00

Price: $495.00

location (For multiple locations contact Customer

c Recorded Access recorded version only for one d e f g participant; unlimited viewing for 6 months ( Access

News

information will be emailed 24 hours after the Why should you attend: The U.S. FDA cGMPs and the completion of live webinar) European Medicines Agency (EMA) expect QA/RA leadership at Price: $295.00 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 Refund Policy 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 rocketscience, 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.

Reprocessing of Reusable Medical Devices Drug Recalls MedWatch: The FDA Safety Information and Adverse Event Reporting Program Recalls, Market Withdrawals, & Safety Alerts Food Defense & Emergency Response Food Ingredients & Packaging

Areas Covered in the Session: Why leadership? The Change Agent You "Inc." Vision and Urgency Credibility-building 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 QA RA R&D Engineering Production Operations Consultants

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs,

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product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA. Customer Reviews: No Reviews Yet. Be The First To Review This Webinar!

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Leadership! - In the Non-Leadership Position  

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