FDA GMP - SupplySide West 2010

Official GMP Training Program at SupplySide

Presented by

The official GMP training workshops at SupplySide are designed to provide real-world, hands on training and tools to help anyone involved in dietary supplement GMP compliance. Far from a lecture or seminar, these interactive training courses delve into the actual processes and procedures you must understand and implement to ensure GMP compliance.

FDA has already conducted hundreds of GMP inspections, and the results of these initial inspections form the foundation of the content for these two unique training courses.

These courses are geared to those individuals involved in the dietary supplement industry,

Manufacturing
Labeling
Management
Auditing
Quality Control/Assurance
Suppliers and Distributors
Laboratory Operations
Regulatory Affairs

Course Details and Fees

Courses are available individually or combined. Register for both courses and receive a package discount. Register 4 or more people from the same company and receive an additional 10% discount.

Course One: Documentation Management for GMP Compliance

Tuesday, October 19, 8am-5pm

This full-day training course will cover the development and management of documentation integral to 21 CFR 111 including Standard Operating Procedures (SOPs), batch production records, master manufacturing records, and much more.

At FDA’s featured presentation at SupplySide West 2009, the agency emphasized the need for written records in all aspects of GMP compliance, at one pointing saying “if it isn’t written down, it didn’t happen.” In fact, written record keeping seems to be one of the most commonly cited deficiencies during FDA GMP inspections. There is a right way to handle the record keeping component of GMP compliance, and it applies to every section of the rule, including:

Personnel -- Physical plant and grounds -- Equipment and utensils -- Production and process control systems -- Quality control -- Components, packaging and labels -- MMRs (Master Manufacturing Records) -- BPRs (Batch Production Records) -- Laboratory operations -- Manufacturing operations -- Packaging and labeling -- Holding and distribution -- Returned dietary supplements -- Customer complaints -- Records and record keeping -- Adverse Events

Course participants will learn:

How to write an SOP and understand the importance of their implementation into a company’s processes.
The importance of the accuracy and maintenance of Batch Production Records (BPRs) and Master Manufacturing Records (MMRs).
Details on what should be included in an SOP for Laboratory Operations; Manufacturing Operations; Packaging & Labeling, Holding and Distribution, Returned Dietary Supplements, Customer Complaints and more.

Course Two: FDA GMP Inspection Readiness

Wednesday, October 20, 8am-Noon

FDA is actively conducting GMP compliance inspections of dietary supplement companies nationwide. Early reports from the agency suggest that there are key areas of misunderstanding and deficiencies. In fact, at SupplySide West 2009, the agency emphasized many areas of interest or concern, such as

Proper written record keeping.
Sufficient qualification and auditing of suppliers, both domestic and foreign
Supplier audits specific to each ingredient, not simply audits of the supplier
100% identity testing for dietary ingredients
Maintenance of records for all consumer complaints with GMP implications
And much more

This course will give you an understanding of the FDA inspection process, critical considerations and steps to accomplish before an inspection takes place, management of the process and issues that arise during an actual FDA inspection, and essential follow-up activities to ensure a positive ending to this inspection and good positioning of your company for future inspections.

Course participants will learn:

How to focus inspection preparation efforts to align with FDA expectations
Specific tasks to accomplish when preparing for FDA inspections
Tools and techniques to successfully manage FDA inspections
List of vital activities following an FDA inspection

Trainers:

Manny Jimenez

Manny Jimenez has been working for NSF International since 2004 covering consulting and auditing services in the area of dietary supplements. He has more than 34 years of experience with Hoffman-La Roche Inc. where he served as a research chemist in the medicinal chemistry department for ten years and as a production manager for processes dedicated to the production of bulk vitamins. In addition, Jimenez served as the compliance manager for the Custom Products Unit, which focused on the production of custom liquid and solid vitamin premixes for the dietary supplement and food industries. In addition to managing process operations, his efforts over the years focused on designing and managing quality systems in the dietary supplement area. He received his bachelor’s degree in chemistry from the State University of New York at Oneonta, and his master’s degree in chemistry from Rutgers University.

Bill Kracht

Bill Kracht has been working for NSF International in the dietary supplements program since 2005 training, consulting and auditing. Previously, he ran his own consulting, training and auditing business. Before that, he spent nearly thirty years in the chemical, pharmaceutical and related industries where he successfully had a 15-year stretch of FDA GMP and GLP inspections without a single nonconformance being written by the FDA. Kracht was one of the first RAB-certified lead auditors in the United States and is a frequent speaker/trainer at several national and international quality conferences. He is also three-time past chairman of the International Conference on ISO 9000 and Related Standards.

Course Pricing / Packages / Discounts

PRICING
Documentation Management For GMP Compliance	$1195
FDA GMP Inspection Readiness	$599
Full Training, Both Modules	$1495

A 10% discount is offered for companies registering 4 or more people. To receive this discount, call us at (800) 454-5760 or supplysideinfo@vpico.com.