Events
May 23, 2012 - May 24, 2012
Effective Document Management for the Pharmaceutical, Biotech and Medical Device Industries
If you didn’t write it down, it didn’t happen! This is the position of the FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from discovery through marketplace. It is also important for due diligence and regulatory inspections, and is necessary for the success of your products and services. While the regulations tell you what you must do, they don’t tell you how. Based on industry best practices, this course clarifies how to refine your existing system, create a new one, or prepare to transition from a manual system to electronic controls. This course also addresses what documents you need to control, what documentation you need to support your actual system and how to keep your documents current and compliant.
Los Angeles, CA
www.cfpie.com
June 4, 2012 - June 5, 2012
PDA/FDA Glass Quality Conference
In the recent past there have been several recalls and increasing concerns about pharmaceutical glass packaging. Pharmaceutical manufacturers, regulators, and glass suppliers all share a common goal of assuring the highest quality products (including packaging) for patients. The PDA/FDA Glass Quality Conference will discuss these issues; best practice to preventing and/or detecting at risk glass packaging; and review current expectations to ensure that recalls are avoided and container closure integrity is assured.
Bethesda, MD
www.pda.org/glass2012
June 4, 2012 - June 5, 2012
Practical Methods for Project Management
After completion of this course the attendee will have a strong understanding of the principles and practices of Project Management. This course delivers strategies on how to effectively manage project personnel, timelines, objectives and the expectation of superiors.
King of Prussia, PA
www.cfpie.com
June 11, 2012 - June 12, 2012
Validation of Computer Systems
This course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The course targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach. The core elements of a satisfactory computer validation program will be emphasized.
Los Angeles, CA
www.cfpie.com
June 11, 2012 - June 12, 2012
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
Complex processes yielding complex products such as biologics and biopharmaceuticals demand numerous, non-compendial, and sometimes complex, QC test methods to confirm manufacturing consistency and product quality. This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays. This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC in biologic and biopharmaceutical companies. The course will cover validation of QC analytical test methods (e.g., electrophoretic, HPLC, peptide mapping, etc.), cell-based potency bioassays, immunochemical binding impurity assays and adventitious agent assays.
Los Angeles, CA
www.cfpie.com
June 12, 2012 - June 13, 2012
FDA Inspections -What Regulators Expect and How to Prepare
This course is designed to provide participants with an understanding of the parameters of a typical inspection, and the common concerns of FDA inspectors. Additionally, participants will learn the approaches often taken by inspectors, and the tools for preparing, coping with, and managing inspections in pharmaceutical, biologics, and medical device facilities.
Los Angeles, CA
www.cfpie.com
June 13, 2012 - June 15, 2012
QA/QC Strategy for Biopharmaceuticals and Biologics
This QA/QC training course highlights the challenges and pressures facing QA/QC in today’s biologic and biopharmaceutical environment, and presents the strategic importance and value generated by QA/QC for their involvement in control of the manufacturing process, and testing and release of these products. QA/QC regulations and guidances from the U.S. FDA, EMEA and ICH are discussed in detail.
Los Angeles, CA
www.cfpie.com
June 18, 2012 - June 21, 2012
TechConnect World
TechConnect World brings together over 4,000 business and technical professionals including leading researchers, buyers, entrepreneurs, corporate business developers, investors, service providers, commercialization/tech transfer officers, industry analysts and members of the media. Matching buyers and sellers, creating strategic partnership, IP licensing, venture capital, corporate financing and customer acquisition opportunities, access to advanced research insight and best practices.
Santa Clara, CA
www.nsti.org
June 18, 2012 - June 19, 2012
2012 PDA Innovation and Best Practices on Sterile Technology Conference
Sterile Processes: Product Development
This Conference will bring together all levels of industry professionals to network and benefit from a program that will explore new and improve best practices on sterile technology. This 2 day conference will provide participants with a comprehensive review of contemporary practices for the conduct of terminal sterilization and aseptic processing with special emphasis on process simulation, risk assessment/mitigation, parametric release and post-aseptic fill lethal treatments.
Chicago, IL
www.pda.org/steriletechnology2012
June 20, 2012 - June 22, 2012
CMC Regulatory Compliance for Biopharmaceuticals and Biologics
This course also includes a discussion on preparing CMC sections for a market application dossier using the Common Technical Document (CTD) formatted Modules 2.3 and 3 for biopharmaceuticals and biologics. CMC compliance regulations and guidances from the U.S. FDA, EMEA and ICH are discussed.
Los Angeles, CA
www.cfpie.com