SWSCC September 2017 Chapter Meeting - night
15175 Quorum Drive
Addison, Texas 75001
5:15PM On Site Registration
5:30 PM Technical Presentation
6:30 PM Cocktail Hour w/ Passed Hors D’oeuvres
7:00 PM Dinner & Presentation: “Success Circle Four Styles to Championship Communication”
Cleaning Validation for Cosmetic Manufacturing
Amy Bradford, Principal Consultant, Commissioning Agents, Inc.
The 1938 Food, Drug and Cosmetic Act provided the first authority for the FDA to regulate the cosmetic industry. Although the FDA did take some steps to regulate the cosmetic industry, it was mainly in adulteration and misbranding, and at the time, the agency established a “self-regulation” approach to cosmetic production. Since then, there has been great expansion and many changes to the cosmetic industry. With the introduction of new products, many of which are considered OTC’s, the line between the cosmetic and pharma industry has become blurred. As these changes have occurred, the FDA now regulates many products as both a cosmetic and a drug, and these may be manufactured in the same location as many non-drug formulations. These and other changes in the industry and consumer awareness have led the FDA to become more thorough and strict in their inspections, and to publish guidance documents for the industry in 1997, with revisions in 2008 and 2013.
One of the areas of stricter requirements has become validation of cleaning programs and procedures. Shortfalls in this area can be directly related to adulteration in the form of contamination or cross contamination between products. In this presentation, we will be discussing the regulations and guidance, both historical and present, for cleaning equipment and methods, cleaning validation requirements and strategies to meet requirements, the impact of legacy systems, and common issues and possible resolutions.
Passed Hors D’oeuvres: Beef Tenderloin Crostini & Smoked Salmon Crostini w/ fresh dill
Salad: Mixed Greens w/ Candied Pecans, Dried Cranberries & Champagne Vinaigrette
Entrée Choices: Grilled Norwegian Salmon, 8 oz. Filet Mignon, or Chicken Breast Piccata
Side Items: Garlic Mashed Potatoes & Green Bean Almandine
Dessert Choices: Berries Romanoff/Fresh Mint, Black & White Godiva Cheesecake, or Grand Marnier crème Brulees
Members - $50
Non-Members - $65
|Event Date||September 14, 2017 5:15 pm|
|Event End Date||September 14, 2017 8:00 pm|
|Registration Start Date||September 04, 2017|