This FDA warning letter closeout program will discuss how to successfully complete warning letter close out program which will help firm to obtain a closeout letter from FDA.

The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Also discussed will be logistical issues with managing the supply of an early stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Perspectives for different classes of products will be presented using case studies.

This training on FDA’s regulation of cosmetic labeling will detail the labeling requirements for manufacturers, packers and labelers of cosmetic products in the United States. It will also cover general labeling and ingredient-related limitations that federal laws and regulations place on cosmetic products.

A weekly meet-up with a distinctly social twist where people can expect to find their entrepreneurial compatriots.

Startup Weekend is a global grassroots movement of active and empowered entrepreneurs who are learning the basics of founding startups and launching successful ventures. It is the largest community of passionate entrepreneurs.

A low barrier bi-weekly meetup for any type of entrepreneur looking to connect. Hosted by Allan Tear and Melissa Withers.

Footscray Maker Lab

Startup Weekend is a global grassroots movement of active and empowered entrepreneurs who are learning the basics of founding startups and launching successful ventures. It is the largest community of passionate entrepreneurs.

In this class, you will learn strategies of networking which builds strong relationships, gets referrals and increases the sales of your company.

Join us for food, drinks and networking (hashtag: #youngtreps), with a mix of students who aspire to be entrepreneurs, and established small-business owners who can talk about their successes and challenges.

As part of the evening, we’ll host a live photo blog on the Globe’s website, and we’ll shoot video with attendees to post in the weeks following the event.