FDAnews Announces Leading the Climb: Seven Essentials of GMP

Falls Church, VA, July 26, 2013 --(PR.com)-- 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 (Aug. 19 and 20) in Philadelphia, Leading the Climb: Seven Essentials of GMP. Register now to 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 you
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.

Register Now — Save $200
Register by July 26, and the price is only $1,597. After that, the price is $1,797. Register now and save.

Room and Team Discounts Available – Act Now: Hotel Space & Discounts Will Be Going Very Quickly
Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment. Call +1 (703) 538-7600 for details.

To reserve your room, call the hotel at the number below. Be sure to tell the hotel you’re with the Leading the Climb: Seven Essentials of GMP conference to get the reduced rate. Space is limited; hotels may run out of discounted rates before the reservation cutoff date, July 29. The discounted rate is also available two nights before and after the event based on availability. Hotels may require first night’s room deposit with tax. Room cancellations within 72 hours of the date of arrival or “no-shows” will be charged for the first night’s room with tax.

Conference Details
Leading the Climb: Seven Essentials of GMP
**Presented by LearningPlus and FDAnews**
Aug. 19-20, 2013 – Philadelphia, PA
www.fdanews.com/LeadingClimbPR2

Tuition:
Early Bird (available until July 26, 2013): $1,597
Regular Rate (after July 26, 2013): $1,797

4 Easy Ways to Register
www.fdanews.com/LeadingClimbPR2
By phone: 888-838-5578 or 703-538-7600
Fax: 703-538-7676
Mail to: FDAnews
300 N Washington St
Ste 200
Falls Church VA USA 22046-3431