FDAnews Announces: Leading the Climb: Seven Essentials of GMP Workshop, Nov. 17-18, 2016, Arlington, VA

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As the regulatory environment changes and manufacturing best practices evolve, so does GMP. Stay current by attending this two-day workshop, Leading the Climb: Seven Essentials of GMP, November 17-18, 2016 in Arlington, VA.

Leading the Climb:
Seven Essentials of GMP
Nov. 17-18, 2016 – Arlington, VA
http://www.fdanews.com/leadingtheclimb

What Do Mountain Climbing and GMPs Have in Common?:
In both, it’s safer and easier if you have the necessary technical and leadership skills. Leading the Climb: Seven Essentials of GMP is an advanced two-day workshop led by an instructor with more than 25 years of pharmaceutical industry experience. Those who will benefit include employees with supervisory/management responsibilities and others working in quality, compliance, training and staff/technical positions. The training covers GMP expectations in the U.S., Canada, Europe and the World Health Organization (WHO).

An Interactive Seminar that Builds on Real-World Lessons:
The curriculum is designed to carefully reflect the latest revised FDA enforcement data and warning letters. It employs a unique LearningPlus video that builds on the analogy of mountain climbing by showing two experienced guides taking a new climber on an ice ascent in the Canadian Rockies. It guides participants through role modeling, systems thinking, coaching and feedback. Participants will use and keep a resource book containing a variety of regulatory reference documents, warning letters, and articles. In addition, a riveting case study illustrates the business, personal and financial impact of not meeting GMPs.

The 7 Essentials You Will Learn to Successfully Implement:

1)    Protect the product from contamination
2)    Prevent mixups
3)    Know why, how and what you are doing before you do it
4)    Document all activities
5)    Strive for consistency and control – qualification, validation and change management
6)    Have management that supports an independent group that makes final decisions on documents, product release and quality
7)    Learn from mistakes and solve problems while continuing to monitor and improve

As the regulatory environment changes and manufacturing best practices evolve, so does GMP. Stay current by attending this two-day workshop, Leading the Climb: Seven Essentials of GMP. Attendees will learn:

  • The personal, regulatory and business consequences of failing to meet GMP expectations in pharma and biopharma manufacturing
  • Technical and leadership skills
  • Key words and concepts related to good manufacturing practice
  • How regulations, guidelines and best practices contribute to current GMP expectations
  • The many ways quality system elements affect your role
  • How auditors and regulatory inspectors will evaluate
  • Ways to satisfy the seven GMP essentials during emergencies
  • What’s expected of personnel at all levels on the pharma and biopharma manufacturing chain

Information You Need from an Authority in the Field
Presenter James Vesper designs and develops instructional courses and workshops for the pharmaceutical and medical device industries. He is founder and president of LearningPlus, Inc., and has more than 30 years' experience in the pharmaceutical industry, including 11 years at Eli Lilly. His work there included serving as project leader of GMP education and instruction. He also presents papers and workshops at various international technical and professional meetings, including the International Society for Pharmaceutical Engineering, GMP TEA, PDA, Pharmaceutical Sciences Group and PharmTech. In 2001, he was awarded the PDA's Agalloco Award for Excellence in Training. He is also an advisor to the World Health Organization's Global Learning Opportunities/Vaccine Quality Group and has mentored, designed and developed learning programs in use worldwide.

Conference Details
Leading the Climb:
Seven Essentials of GMP
Nov. 17-18, 2016 – Arlington, VA
http://www.fdanews.com/leadingtheclimb

Tuition: $1,797
Significant team discounts are available.

Easy Ways to Register
Online: http://www.fdanews.com/leadingtheclimb
By phone: 888-838-5578 or 703-538-7600

About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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