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- December 2011
- January 2012
- February 2012
- March 2012
- April 2012
- May 2012
- June 2012
- July 2012
- September 2012
- October 2012
December 2011
Stability Programs for Product Shelf Life – From Development to Approval
December 5-6, 2011
Berlin, Germany
This continually updated course covers current regulatory requirements and ICH guidelines for designing stability programs from the early stages of product development all the way to approval. Among the topics to be discussed will be:
- Purpose of stability studies and requirements for each type of study
- FDA and other health authority guidances and ICH stability guidelines
- Writing stability program SOPs
- Design of stability studies and stability protocol development
- Establishing successful stability data management systems
- Conducting and documenting OOT/OOS and deviation investigations
- Chemistry and testing considerations underlying the stability data
- Stability chamber selection, qualification and maintenance
- Stability sample management, cradle to grave
- Preparation for inspection of stability programs by regulatory agencies
- Case studies and lessons learned
Active Pharmaceutical Ingredients (API) and Drug Product Specifications
December 7-9, 2011
Berlin, Germany
This continually updated course covers the broad range of operations involved in the development of a New Chemical Entity (NCE) - from discovery to the filing of a New Drug Application. Emphasis will be placed on discussing stability issues, impurity profiles, polymorphism, bioequivalence, bioavailability and chemical route selection. Participants will also understand the specifications needed to meet current FDA regulatory requirements and ICH guidelines. Selected case studies will be presented to illustrate the concepts covered throughout the course.
Validation of Computer Systems
December 8-9, 2011
Los Angeles, CA
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.
Topics to be discussed include:
- The regulatory expectations for computer validation
- Relevant FDA warning letters
- The tasks and deliverables expected for computer validation
- Why validation processes vary so much
- Strategies for practical, yet defensible computer validation
- Sops required for system operation and maintenance
- 21 CFR part 11 and it’s implications for common regulations
- An active discussion of part 11 examples and audience questions
- The implications of GAMP 5 on computer validation and how to transition from GAMP 4
- Auditing GXP computer systems and suppliers
January 2012
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
January 9-11, 2012
King of Prussia, PA
Best Practices for An Effective Cleaning Validation Program
January 23-24, 2012
King of Prussia, PA
Process Validation for Drugs and Biologics
January 25-26, 2012
King of Prussia, PA
January 22-25, 2012
Baltimore Marriott Waterfront - Baltimore, MD
IFPAC is the essential meeting place for the latest developments in Process Analytical Technology...PAT and Quality by Design...QbD within the Pharmaceutical and Biotechnology Industries. IFPAC is known for being a collaborative forum to exchange ideas and network through panel discussions, evening sessions, poster sessions, and the exhibition. For over 25 years IFPAC has brought together practitioners from industry, academia and government to discuss new trends in technology, standards, and controls.
IFPAC-2012 will feature comprehensive Pharmaceutical/Biotechnology tracks including the topics: Real-Time Release, Continuous Manufacturing, Risk Management, Sampling, Industrial Bio-Processing, BioReactors, PAT Applied for Biologics Manufacturing, Life Cycle Management of Analyzer and Method Reliability, Imaging, Particle Characterization, Screening and Surveillance, and various analytical techniques including: NIR, Raman, MS and LIF... plus involvement by the International Consortium for Innovation and Quality in Pharmaceutical Development. For more information contact: IFPAC Conference Management (847) 543-6800 or info@ifpacnet.org www.ifpacpat.org.
CBI’s 3rd Annual Life Sciences Executive Forum on Strategic Sourcing and Procurement
January 25-26, 2012
Philadelphia, PA
Drive Value. Maximize Savings. Ensure Compliance. Bring value to the organization while meeting critical market objectives and internal goals for savings. CBI’s 3rd Strategic Sourcing and Procurement is the must-attend event for senior-level Strategic Sourcing, Procurement, Supplier Relationship Management and Outsourcing professionals. This meeting discusses ways to raise the bar savings awareness without degrading the value proposition.
February 2012
The Drug Development Process - from Discovery to Commercialization
February 1-3, 2012
King of Prussia, PA
Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries
February 2-3, 2012
King of Prussia, PA
ARC 16th Annual Forum: Driving Innovation, Sustainability, and Performance
February 6-19, 2012
Renaissance Orlando - Orlando, FL
Industrialization in emerging regions and revitalization of aging infrastructure are fueling a new wave of capital investment around the world. IT and other technologies are enabling organizations to become smarter, more collaborative, and more integrated with their customers and supply chains. We are in the midst of an era with huge opportunities - and huge challenges - for industrial companies. Excellence in every aspect of business is vital for growth and survival.
Excellence cannot be achieved in isolation, however. It requires perfect execution, agility, and collaboration across key functional areas like IT, engineering, operations, and maintenance. Innovation must also be a priority. New business models, products, processes, and production techniques can enhance the value proposition for every business in every industry.
ARC's World Industry Forum focuses on all of these challenges and can help you develop winning strategies. It provides the ideal environment for industry executives to collaborate, share ideas, and find new ways to attack their most pressing problems. The event includes sessions on the major issues facing our industry, with multiple tracks that enable executives to explore these topics from different perspectives. Owner/operators, solution providers, and technical experts will all benefit from this experience while simultaneously contributing to the community's body of knowledge.
For more information visit our Web site.
February 14-17, 2012
Morial Convention Center - New Orleans, LA
Informex is the leading meeting place for buyers and sellers of high-value chemistry. The 28 year old event is a marketplace for networking and doing business in the fine, custom and specialty chemical manufacturing industry. The international mix of more than 4,000 chemistry professionals and 500 exhibitors for the 4 day, all encompassing, event makes Informex a must-attend every year.
Conferences
After the successful launch of conference content in 2011 Informex will once again add value to your visit by bringing you thought-leading business focused sessions alongside the show.
Poster Pavilion
Following the sell-out debut of the Chemistry Innovations Poster Pavilion in 2011 Informex will again promote a platform for exhibitors and attendees to feature their new innovations.
Profiles in Sustainability For the third year running Informex will host a green chemistry award. The prestigious Profiles in Sustainability award will again be awarded to companies who demonstrate unique and viable green products and processes.
Networking
The Informex signature networking events will be as plentiful and prominent as ever for the return to the Big Easy.
Join the top business professionals in the chemical industry by attending Informex 2012 in New Orleans. Pre-register now for Informex now by visiting our website www.informex.com.
FDA Inspections -What Regulators Expect and How to Prepare
February 15-16, 2012
King of Prussia, PA
Biopharmaceutical Development & Production Week: Process & Product Validation
February 27-28, 2012
Hilton San Diego Bayfront, San Diego, CA
Moving Towards a LifeCycle and Risk-based Approach for Continuous Validation. Part of IBC’s Biopharmaceutical Development & Production Week.
This conference provides insights into the interpretation and implementation of FDA's Process Validation Guidance and QbD approaches, while examining the roles and impact of knowledge management and quality risk management on continuous verification.
Complete event details and online registration can be found at: www.IBCLifeSciences.com/Process. Mention priority code BDP12PMEL to save 20% off the standard rates. New registrations only.
Biopharmaceutical Development & Production Week: Outsourcing Manufacturing of Biopharmaceuticals
February 27-28, 2012
Hilton San Diego Bayfront, San Diego, CA
Risk Mitigating and Productivity Improvement through Successful Partnering & Co-Development with CMOs. Part of IBC’s Biopharmaceutical Development & Production Week.
This conference provides you insights into developing your risk-mitigation strategies and operational excellence that oversees supply chain security and raw material reliability, thereby delivering a successful agent-sponsor relationship and ensuring consistent high quality products from your CMO partners.
Complete event details and online registration can be found at: www.IBCLifeSciences.com/Outsourcing . Mention priority code BDP12PMEL to save 20% off the standard rates. New registrations only.
Biopharmaceutical Development & Production Week: Technology Transfer for Biopharmaceuticals
February 27-28, 2012
Hilton San Diego Bayfront, San Diego, CA
Maximizing Facility Throughput, Accelerating Timelines and Ensuring Partnership Success in Technology Transfer. Part of IBC’s Biopharmaceutical Development & Production Week
This conference gives you an inside look at trouble-shooting transfer challenges while developing strategies to minimize risk, enhance productivity, and ensure efficient and smooth technology transfers.
Complete event details and online registration can be found at: www.IBCLifeSciences.com/Transfer . Mention priority code BDP12PMEL to save 20% off the standard rates. New registrations only.
February 27-28, 2012
Hilton San Diego Bayfront, San Diego, CA
Strategies to Identify, Test, Control and Mitigate Risk of Raw Material Variability in Upstream/Downstream Development and Clinical/Commercial Manufacturing
New to the market, this conference offers strategies to identify raw material variability as a potential problem before it happens, solutions for controlling and mitigating the risk of raw material variability in process development and manufacturing and techniques for working with raw material suppliers to ensure raw materials meet quality/safety standards.
Complete event details and online registration can be found at: www.IBCLifeSciences.com/RawMaterials . Mention priority code BDP12PMEL to save 20% off the standard rates. New registrations only.
Biopharmaceutical Development & Production Week: Viral Safety for Biologicals
February 27-28, 2012
Hilton San Diego Bayfront, San Diego, CA
Strategies, Technologies and Regulatory Perspectives for Detection, Prevention and Remediation in Upstream, Downstream and Manufacturing Operations
With up-to-date strategies for detection and prevention efforts for laboratories and facilities, various new methods for virus spike preparation and the implementation of platform processes/ modular viral clearance, as well as updates from several regulators representing the FDA and the European regulatory bodies, this event will attract forward thinking people from across the industry.
Complete event details and online registration can be found at: www.IBCLifeSciences.com/ViralSafety . Mention priority code BDP12PMEL to save 20% off the standard rates. New registrations only.
Biopharmaceutical Development & Production Week: Antibody Development & Production
February 27-28, 2012
Hilton San Diego Bayfront, San Diego, CA
Combining Technical and Scientific Innovations with Industry Collaboration to Overcome Bioprocessing Challenges
This conference offers you the highest quality and most in-depth coverage of the latest technical and scientific advances in bioprocessing to help companies (of all sizes) improve the speed, quality and cost of developing and producing antibodies. Exclusive case studies delivering the latest data together with strategic discussion forums allow the industry's leading scientists, engineers and executives to collectively collaborate and provide solutions to their most pressing challenges.
Complete event details and online registration can be found at: www.IBCLifeSciences.com/Antibodyprod . Mention priority code BDP12PMEL to save 20% off the standard rates. New registrations only.
February 27-28, 2012
Hilton San Diego Bayfront, San Diego, CA
Approaches to Overcome the Unique Technical and Scientific Challenges of Developing Novel Molecules
This conference covers the entire spectrum of topics related to improving the efficiency of developing and producing next generation and novel molecules. The conference presentations bring together the industry experts representing companies of all sizes to share successful approaches that can help you overcome the unique technical and scientific challenges in upstream and downstream processing.
Complete event details and online registration can be found at:www.IBCLifeSciences.com/Recombinant . Mention priority code BDP12PMEL to save 20% off the standard rates. New registrations only.
February 27-28, 2012
Hilton San Diego Bayfront, San Diego, CA
Implementing Novel Analytical Approaches and Technologies from Early to Late Stage Development to Enable Project Progression
This conference offers you the unique opportunity to hear how your peers are successfully developing and integrating novel analytical approaches and technologies to optimize quality at every stage of process and product development. Attendees will learn how companies are developing and implementing the analytics of the future and their impact on bioprocessing.
Complete event details and online registration can be found at: www.IBCLifeSciences.com/Analytical . Mention priority code BDP12PMEL to save 20% off the standard rates. New registrations only.
February 27-28, 2012
Hilton San Diego Bayfront, San Diego, CA
Turning Potential into Realistic Opportunities and Commercial Viability
Here is THE conference that will help address these scientific and technical questions you have always wanted to know. Hear who’s developing what, and how they are doing it, plus what’s coming out of their pipelines. Get the answers to what differentiates a biobetter from an existing drug or another biobetter; and what defines the similarity in biosimilars.
Complete event details and online registration can be found at: www.IBCLifeSciences.com/Biobetters . Mention priority code BDP12PMEL to save 20% off the standard rates. New registrations only.
IVT’s 2nd Annual Validation and cGMP Compliance Week Singapore
February 28-29, 2012
Singapore
IVT’s Validation and cGMP Compliance Week Singapore is a two-day event and exhibition bringing together quality, validation and regulatory representatives who present their experiences in validation and GMP compliance within three cutting edge tracks — Validation, Quality Systems and Aseptic Processing. This case-study driven event includes workshops on implementation strategies for these specific areas of compliance. Register now at www.cbinet.com/valweeksingapore and save $400 with priority code VWSPM4.
March 2012
Sterilization Procedures Technology, Equipment & Validation
March 7-8, 2012
King of Prussia, PA
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
March 26-27, 2012
Los Angeles, CA
Pharmaceutical Production Batch Record Review
March 26-27, 2012
Los Angeles, CA
IVT’s 3rd Annual Validation Week EU
March 28 - 30, 2012
Dublin, Ireland
IVT has been in the forefront of promoting good validation practice for the last three decades. Today, new global regulations, technology advances and industry case studies have molded how to develop, implement and deploy validation procedures company-wide. Validation Week EU is a three-day event covering validation from A to Z, including; process, computer, equipment, method, facility, cleaning and much more. Register now at www.cbinet.com/valweekeu and save €300 with priority code VWEUPM.
April 2012
April 16 - 18, 2012
Phoenix, AZ (JW Marriott Desert Ridge Resort)
The PDA Annual Meeting is the one meeting each year dedicated to advancing the careers of pharmaceutical and biopharmaceutical professionals by focusing program content on science and technology innovation as well as optimized performance. As the manufacturing of quality products is a keystone of our industry, the 2012 PDA Annual Meeting's theme is Manufacturing Innovation: Achieving Excellence in Sterile and Emerging Biopharmaceutical Technology.
IVT’s 13th Annual Computer and Software Validation
April 16 - 18, 2012
San Diego, CA
Computer and software validation practice is evolving quickly with the emergence of virtual networks, cloud computing, SaaS and social media. The urgency of securing data integrity and complying with global regulations has never been greater. This industry landmark event, in its 13th year, aligns current global regulations and best practices delivered by industry experts. Register now at www.cbinet.com/csv and save $400 with priority code CSVPM4.
PDA Single Use Systems Workshop
April 18 - 19, 2012
Phoenix, Arizona (JW Marriott Desert Ridge Resort)
The PDA Taskforce for Single-Use Systems is completing a Technical Report on the implementation of Single-Use Systems and would like to invite you to attend the PDA Single Use Systems Workshop following the 2012 PDA Annual Meeting. The workshop will showcase and encourages the philosophies championed in the Technical Report and offer a different approach, presenting science and risk-based concepts which are flexible and can be applied in many different situations and organizations.
April 24 - 25, 2012
Hotel Palace Berlin
Using pragmatic approaches to QbD implementation in a GMP environment.
At the event you will hear unique examples and practical solutions to implementation vis-a-vis current and future regulatory expectations and gain best practice guidance through insightful speaker presentations and have the option to attend streamed sessions on either QbD for the pharma industry or themes specifically dedicated to implementing QbD for biopharmaceuticals. Speaker companies include: Abbott, Baxter Healthcare Corporation, Merck Serono S.A, F. Hoffman-La-Roche Ltd, Synthon Pharmaceuticals, Lonza.
Book today at www.pharmaqbdforum.com/SB2 or call +44 (0) 207 202 7727.
May 2012
May 1-3, 2012
Javits Center - New York, NY
INTERPHEX is the leading annual pharmaceutical and biopharmaceutical trade show. Key decision makers find the networking opportunities, products, services and information they need to ensure quality and maximize efficiency, agility, and flexibility that solve manufacturing and supply chain problems. INTERPHEX is where intelligence and passion intersect with the full spectrum of industry products and services to create new insights and innovation. Find out more at www.interphex.com.
May 8-9, 2012
Boston Marriott Long Wharf, Boston, MA
IMACS, the International Meeting on Automated Compliance Systems, is for professionals in life science industries who are interested in paperless execution and documentation of compliance-based processes to improve operational efficiency and reduce cGMP compliance risks. If your company is considering, evaluating, implementing, or using lab execution systems, electronic lab notebooks, LIMS, and chromatography data systems for analytical development and quality control testing, this event is for you!
For more information on IMACS 2012 as the agenda evolves, visit www.imacs2012.eventbrite.com or email the organizers at info@imacs-world.com. If phone contact is preferred, call (508) 497-0128.
PTXi | International Powder & Bulk Solids
May 8-10, 2012
Donald E. Stephens Convention Center - Rosemont, IL
ProcessTechExpo.com PTXi | International Powder & Bulk Solids is the industry event for process manufacturing with the largest and most comprehensive North American exhibition and conference dedicated to the U.S. and international process industries. Access the latest technologies, expertise and ideas to help you increase production efficiencies and ensure product consistency. Register today--Visit us at PowderShow.com for complete show details.
June 2012
June 6 - 7, 2012
Donald E. Stephens Convention Center - Rosemont, IL
Sensors Expo & Conference is the only industry event in North America exclusively focused on sensors and sensor-integrated systems, providing over 25 years of technical innovation and thought leadership! The conference program is dedicated to exploring the most up-to-date innovations in sensor technology, including MEMS, Energy Harvesting, Wireless Sensor Data & Networks, Measurement & Detection, and more. Sensors Expo & Conference identifies cutting-edge trends, explores them in an information-packed conference program and reflects those trends throughout the exhibit floor with new product announcements, key technology-focused areas, such as Energy Harvesting, MEMS and Wireless, and a showcase of hundreds of products and services. Visit www.sensorsexpo.com for the latest information. Special offer for Subscribers: register using code A324H for special savings today!
July 2012
OPM Outsourcing Pharmaceutical Manufacturing
July 24 - 25, 2012
Loews Philadelphia Hotel, Philadelphia, PA
This conference and premium networking event is a true opportunity to connect and learn key sourcing strategies from some of the most experienced bio/pharma sourcing executives and service providers in the business. In addition, the program highlights proven outsourcing strategies from outside the pharma/bio industry, allowing companies to take away tangible and unique benefits benchmarking against other successful industries. Register today at: http://www.cbinet.com/outsourcing.
September 2012
2012 PDA/FDA Joint Regulatory Conference
September 10-12, 2012
Baltimore, MD
The 2012 PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues. Each year, FDA speakers provide updates on the current state of efforts impacting the development of global regulatory strategies; while industry professionals from some of today’s leading pharmaceutical companies present case studies on how they employ global strategies in their daily processes.
October 2012
PDA’s 7th Annual Global Conference on Pharmaceutical Microbiology
October 22-24, 2012
Bethesda, MD (Bethesda North Marriott Hotel)
PDA's 7th Annual Global Conference on Pharmaceutical Microbiology will bring together all levels of industry professionals to network and benefit from a program that reveals the essential science of microbiology and seeks to solve the problems that our industry faces on a daily basis. The comprehensive program agenda will include presentations from regulatory and industry representatives from around the world who will share recent case studies, current and future trends in the field of pharmaceutical microbiology.
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