About this course
21 CFR 111 regulations require the appropriate GMP training in a facility for personnel to be conducted on a regular basis. The options for meeting this regulatory requirement include having expert consultants on-site to conduct the training on a regular basis, send personnel to external courses for training and/or develop and conduct an internal training program to meet the regulatory requirements.
This course will provide you with the insight into developing training materials, schedules and provide insights into how to integrate a culture of “quality” into your organization. Tools and resources will be provided so that delegates can implement a “quality” training program in their facility.
A company’s most precious assets are its people. Training is essential for the maintenance of high standards of quality assurance and GMP. This undeniable fact is forcefully stated by all the regulatory agencies. In the Dietary Supplement GMPs (21 CFR Part 111):
21 CFR Part 111.14(a) “You must have qualified employees who manufacture, package, label, or hold dietary supplements.”111.14© “Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform the person’s assigned functions.”
Who Should Attend
The training is designed for QA/QC managers, R&D managers and personnel, product developers, analytical method developers and laboratory personnel, quality system auditors and staff, and regulatory personnel.
Course outline
What You Will Learn
- Insight into developing training materials, schedules and provide insights into how to integrate a culture of “quality” into your organization
- Position descriptions, recruiting and hiring
- Training and development concepts and practice/training evaluation
- Record keeping and updating training
Discussion and Working Groups
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods will provide delegates with plenty of time to obtain answers to their specific questions and concerns.
Venue
Galloway, NJ - Seaview
Seaview-A Dolce Resort
401 South New York Road
Galloway, New Jersey 08205
609.652.1800
www.dolceseaview.com
Property Key Facts
- Multi-million dollar renovation project completed March 2011
- 271 luxurious sleeping rooms, including 16 Suites
- 27,000 sq. ft. corporate and special event meeting space
- Two Championship18-Hole golf courses on property: Pines Course and Bay Course
- 22-acre driving range
- 14,000 sq ft. Elizabeth Arden Red Door Spa
- Indoor and outdoor pools
- Tennis and volleyball courts
- 24-hour onsite fitness center
- Two full service restaurants and room service
- Bayview Terrace; 27,500 sq. ft. gracefully landscaped outdoor patio
- Bayview Ballroom corridor; 2,500 sq. ft. satellite gallery for the renowned Noyes Museum of Art of the Richard Stockton College of New Jersey
- Host to the 2011 ShopRite LPGA Classic; May 30 – June 5
Guestroom Key Facts
- 271 Guest Rooms
o 128 King Rooms
o 120 Double Rooms
o 16 Suites
o 6 Executive Bedrooms
o 1 Hospitality Suite
Key Attractions
- Smithville Village (7 minutes)
- Atlantic City (10 minutes)
o Casinos
o The Walk Outlets and The Pier Shopping
o AC Historical Museum and AC Art Center
- Ocean City (25 minutes)
- Atlantic City Airport/FAA Tech Center 7.3 miles
For special room rates, please contact the hotel and mention NSF-DBA. Special discounts may be available for up to 14 days prior to the course.
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our expert for this course is:
What you've said
“NLI is always working to implement the most stringent quality systems and looking for opportunities to prove the superiority of its systems. DSQP certification with NSF-DBA has been another way for NLI to show a commitment to being a CMO of the highest quality. Investment in training ensures your company is in compliance and manufacturing safe products for the public”
Jera’le Smith, Director of Quality Assurance, Nutritional Laboratories International (NLI)
“I attended both NSF-DBA’s FDA inspection Readiness and Corrective Action Management modules and our company assiduously implemented the recommendations made. I am absolutely convinced that doing so was one of the primary reasons our company did not receive an FDA Form 483 following an FDA unannounced 4-day GMP inspection”
Kim Randall Pearson, General Counsel, Thorne Research, Inc.
An NSF International Company