Leadership! – In the Non-Leadership Position – Webinar by GlobalCompliancePanel

Jun 23, 17 Leadership! – In the Non-Leadership Position – Webinar by GlobalCompliancePanel

Leadership! – In the Non-Leadership Position – Webinar by GlobalCompliancePanel

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

Keys to build up credibility. Turn into a “head to” resource. Use of the normal staff support attitude and decrease frustration. Play a far more proactive function in product development, procedure implementation, project administration planning, and corporate lifestyle change. Enhance existing duties in regulatory compliance, audit response, proof cGMP “progress against program”, and other regulated actions requiring a well planned documented rationale. Common equipment for elevated credibility will be talked about. Simple techniques using common Excel- or Word-type PC applications applications which you can use instantly are presented. Regular usage of a few basic but powerful equipment to virtually remove “fire fighting” and enable you to get new credibility. Contribute significantly to your company’s reduced amount of scheduling uncertainty, incomplete tasks when period is running out, elevated item liability, while assisting in company-wide cost reduction initiatives, with less potential for recalls, and a better bottom line.

Thinking about attend: The U.S. FDA cGMPs and the European Medications Agency (EMA) anticipate QA/RA leadership at regulated businesses. Production, advertising, engineering, and senior administration may not trust or end up being accepting of a leadership function from QA/RA. How do these differing mindsets end up being reconciled? As long as they? What component will “incorporating” yourself play? What equipment can help the assumption of such a leadership function in a typically non-leadership position. Such equipment can also supply the perfect response system for conversation with the FDA, by either RA or senior administration; and the EU MDD and their notified bodies are zero different. Also addressed is normally how exactly to gain senior administration support because of this assumed function. Growing high-profile field complications suggest that QA/RA “leadership” is necessary, and what’s currently approved for such “leadership” is normally either poor or non-existant. Be considered a transformation agent for proper quality setting up and execution. The credibility-building methods talked about in this webinar aren’t rocket-research, but require the execution of formal strategies with documentation, and defensible rationale. Use equipment / templates to provide predictability to your company’s QA/RA leadership process. Utilize them to guard your remediation initiatives with the FDA. Utilize them to prove “improvement against plan”. After that “anchor” these initiatives to mitigate entropy.

Areas Covered in the Program:

Who Will Benefit:

Wednesday, December 7, 201110:00 AM PST 01:00 PM ESTPrice List:Live : $245.00Corporate live : $995.00Recorded : $295.00


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

John E. Lincoln is certainly a medical gadget and regulatory affairs consultant. He has helped businesses to implement or change their GMP systems and techniques, product risk administration, U.S. FDA responses. Furthermore, he has effectively designed, written and operate all sorts of process, devices and software qualifications/validations, that have approved FDA audit or submission scrutiny, and defined in peer-reviewed technical content, and workshops, globally. John in addition has managed pilot creation, regulatory affairs, product advancement/style control, 510(k) submissions, risk administration per ISO 14971, and projects; with over 28 years of knowledge in the FDA-regulated medical items industry – dealing with start-ups to Fortune 100 businesses, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He’s a graduate of UCLA.