Conference Program

4:30pm-5:30pm

Keynote Presentation:
A Global Perspective on Pharmaceutical Manufacturing

Edgardo Fabregas
Vice President Manufacturing
Global Pharmaceutical Supply Group & North America, Janssen Ortho LLC

5:45pm-6:30pm

I-01:
Present-Day Technology and Compliance for Pharmaceutical Water Systems

Lee Comb
National Sales Manager
Christ Water Technology Americas, LLC

This presentation describes advances in the preparation and distribution of USP purified water for pharmaceutical product. The focus is on the state-of-the-art water treatment systems used to produce USP Purified Water and design comments on the distribution of the purified water to use points.

Today, the use of single-pass reverse osmosis, followed by electrode-ionization have become the design standard for the production of USP Purified Water. However, the pretreatment designs have been challenged by issues such as high TOC content, the use of chloramines and a number of other problematic scenarios confront the water system design engineer very frequently. This presentation describes the best methods to deal with these challenging problems.

The post treatment and distribution create a number of options one needs to consider to create a 21st century design. Options such as ozone versus heat for microbiological control and proper velocities and user-point regulation are addressed in detail.

I-02:
Effective Technical Writing and Communication Skills

Stella M. Aneiro
Ph.D
Organizational Communication, Inc

This session provides participants with key guidelines and specifications required for clear and credible writing in organizations. The presentation focuses on The Best Practices in Technical Writing as the basis for effective writing and communication. This information impacts the audience by helping them generate factual and authoritative text. In addition, concepts of conciseness regarding word choice, sentence structure, paragraph development, along with aspects related to organization and design in documents are briefly examined to help writers develop succinct and clear documents. Recommended for researchers, quality managers, engineers, supervisors, laboratory analysts, documentation specialists, and all those responsible for writing and documenting in organizations.

6:45pm-7:45pm

Keynote Presentation:
Dr. Enrique Ruelas

Presidente del Consejo de Salubridad General

4:30pm-5:30pm

Keynote Presentation: TBA

5:45pm-6:30

I03:
Risk Management Applied to Control System

Jorge Rodriguez
President, PACIV

This session will provide the background, conceptual theory and, most importantly, a practical approach to the concept of Risk-Based Management in Commissioning & Qualification (C&Q) and Computer System Validation (CSV) with regard to computer control systems and how it applies to them. The presentation, besides providing FDA regulations and guidance such as Q9 Quality Risk Management from ICH as well as non-regulatory guidance (from the industry) such as ISPE C&Q Guideline and GAMP on the Risk-Based Approach Process, will also provide the necessary practical tools to be able to execute a documented risk-based approach of your computer control system validation effort and achieve the "right-sized validation" for the computer control system.

I-04:
21 CFR Part II, Electronic Records-Electronic Signatures

M. en C. Eduardo Tovar
Gerente de Control de Calidad
Industrias Quimicas Falcon

6:45pm-7:30pm

I-05: Application of Disposable Technology in BioPharmaceutical Manufacturing

Mónica Cardona
Marketing Manager-Western Hemisphere, Pall Corporation

Better process development strategies and scaleable technologies are increasingly important as biotechnology companies progress from discovery, to pilot and full-scale drug production. Integrated single use bioprocess systems incorporating filters, tubing, bags, mixing systems and aseptic connection devices can be scaled up faster than their stainless steel counterparts and offer process flexibility every step of the way. These systems offer a wide range of benefits including:

Eliminate cleaning and cleaning validation
Eliminate sterilization
Reduce use of caustic chemicals and WFI consumption
Efficient use of space-smaller over-all footprints
Reduction in cross contamination
Reduce down-time associated with stainless steel assembly/labor
Ability/flexibility to increase production capacity

Integrated single use bioprocess systems have found their place in every step of the drug production cycle. We will discuss an overall strategy to incorporate single use bioprocess systems in to a manufacturing facility. Pharmaceutical companies are looking more closely at their processes to see where quality improvements can be made, safety can be enhanced, and greater efficiency can be reaped. Disposable processing has emerged as a way to achieve these objectives in a cGMP environment. Biopharmaceutical companies are also discovering unique process optimization benefits in pre-filtration and chromatography as new disposable products are introduced for these applications. Process optimization, safety, efficiency and cost benefits will continue to multiply as the industry moves closer to an entirely disposable drug manufacturing paradigm.