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 medical device risk analysis training will explain the relationship between ISO 14971 compliance and the EU MDD. It will discuss how you can update your risk management procedure to meet CE mark requirements for risk analysis.

This banking compliance training focuses on a bank’s internal transfer pricing methods and processes. It will clearly explain the methodological background of pricing and its components with examples and will also provide the necessary organizational steps to put this in practice.

This HR compliance training will be looking at specific considerations regarding the four major HR systems such as compensation, performance management, applicant tracking systems and onboarding systems. It will help you in purchasing and effectively implementing HR technologies at your workplace.

Tech Innovations: How Will Technology Change the Way we do Business in Central Texas. Join us for ABJ's Tech Innovations where we will highlight how technology will change the way we do business in Central Texas. This inaugural luncheon will feature an update on the landscape of technology in Austin including ATC's survey results and conversations between industry leaders and the technologists who serve them.

In the past, security professionals thought firewalls, Secure Sockets Layer (SSL), patching, and privacy policies were enough.

The session will provide specific tips and guidelines to make website code both low risk and less vulnerable.

People everywhere have come to view entrepreneurs as superheroes and rock stars.

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.

Ottawa Python Author’s Group (OPAG) is a group devoted to learning, using and providing resources for the programming language Python (click on the Python image on the top-left of this page for the Python Homepage). OPAG also serves as a general gathering place for Python programmers from the Ottawa region and beyond.

Specialties:Creative financing techniques, financial analysis, strategic planning, recapitalizations, debtor-in-possession financing, working with accredited investors.