Navigation Links
FDA and Conformia Deliver Joint Presentation to Annual Regulatory and Compliance Symposium at Harvard
Date:8/30/2007

pharmaceutical manufacturing

-- Consequences pharmaceutical companies face in the present environment

-- The current state of the regulatory quality review process

-- The mutual goal for industry, society and regulators to reliably

produce high-quality products without extensive regulatory oversight

-- Benefits of the new QbD paradigm for both the FDA and the industry

About the CRADA Study

The CRADA study began in April 2006 as a preliminary study of nine companies and is due to expand to 25 companies. Focusing on understanding the current practices of pharmaceutical development and commercialization, the study is designed to align with the FDA's Current Good Manufacturing Practice (cGMP) initiative for the 21st century and the Critical Path initiative, of which QbD is a key component. The study is unique because it enables companies to openly share their concerns with the FDA without fear of ramifications.

The presentation is available on the Conformia website -- http://www.conformia.com

About Conformia

Conformia is the market leader and innovator in product/process lifecycle management (PPLM) software solutions for regulated process industries including life sciences and beverage alcohol. These solutions enable pharmaceutical companies to save significant time and money through major improvements in product/process development operations by creating central master active pharmaceutical ingredients and formulation databases across the lifecycle. Conformia's web-based enterprise software helps improve product quality, provides a platform for regulatory flexibility, decreases time to market, increases product / process operational effectiveness and streamlines tech transfer. Conformia is offered as an SAP-endorsed business solution for pharmaceutical development operations and beverage alcohol operations. Together SAP and Conformia are building a bridg
'/>"/>

SOURCE Conformia
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. pFB-ERV: Retroviral Delivery of the Ecdysone Receptor Proteins
2. High-Titer Retroviral Vectors for Gene Delivery
3. Unique Enhanced DNA Polymerase Delivers High Fidelity and Great PCR Performance
4. Effectene Transfection Reagent provides efficient gene delivery to primary neuronal cell cultures
5. A New Way to Assess siRNA Delivery Efficiency
6. Delivering siRNA Using Adenoviral Vectors
7. Efficient Delivery of siRNAs to Human Primary Cells: Electroporation vs. Chemical Transfection
8. Delivering siRNAs to Difficult Cell Types
9. Enhanced siRNA Delivery and Long-term Gene Silencing
10. Deliver siRNAs Into Primary Cells
11. High Throughput siRNA Delivery In Vitro: From Cell Lines to Primary Cells
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2015)... SYDNEY , April 17, 2015  US-Australian drug ... signed a Memorandum of Understanding with the Feinstein ... New York to collaborate with ... cancers. The collaboration brings together the ... and clinical expertise of the Feinstein Institute in ...
(Date:4/16/2015)... Bythewood, South Carolina (PRWEB) April 17, 2015 ... solutions and steam system services, released their newly ... 2015. The customer facing website effectively promotes ... proposition. , All the information that a ... training, steam system services, company capabilities, industries serviced, ...
(Date:4/16/2015)... Capillus, LLC announces plans to expand ... Europe and Asia. The Miami-based medical device manufacturer ... Business Development Director of Svenson Group Europe, as ... professional achievements include increasing the number of Svenson ... the Portuguese marketplace with centers in Lisbon and ...
(Date:4/16/2015)... 2015 According to the 2014 ... outside source was ranked first among the leading ... to lifting, pushing, pulling, holding, carrying, or throwing ... The David Round Company takes statistics like this ... hard to develop and design equipment that prevents ...
Breaking Biology Technology:Novogen and Feinstein Institute Join Forces to Find Effective Treatments for Brain Cancer 2Novogen and Feinstein Institute Join Forces to Find Effective Treatments for Brain Cancer 3Novogen and Feinstein Institute Join Forces to Find Effective Treatments for Brain Cancer 4Novogen and Feinstein Institute Join Forces to Find Effective Treatments for Brain Cancer 5Novogen and Feinstein Institute Join Forces to Find Effective Treatments for Brain Cancer 6Spirax Sarco website has a new look 2Capillus, LLC Extends Laser Hair Therapy Products to Europe and Asia 2The David Round Company Helps Companies Meet OSHA Standards by Combining Safety, Ergonomics, and Productivity 2
... ... delivers Market Leading Economies to Reduce Synthesis Costs and Increase Yields , ... Oceanside, CA (PRWEB) April 26, ... and the market leader in solid support for oligonucleotide synthesis, will be launching its ...
... computers are static. In our brains, information processing ... international research team from Japan and Michigan Technological ... evolution in an organic molecular layer that can ... a brain-like "evolutionary circuit" has been realized. ...
... SHANGHAI , April 23 /PRNewswire-Asia/ -- ... that it filed its annual report on Form 20-F for,the ... and Exchange Commission.,The annual report can be accessed on WuXi ... WuXi,PharmaTech will provide a hard copy of its annual report ...
Cached Biology Technology:Kinovate Life Sciences, Inc. and Nitto Denko Corporation Announce Launch of NittoPhaseHL – High Loaded Solid Support for Oligonucleotide Synthesis 2Kinovate Life Sciences, Inc. and Nitto Denko Corporation Announce Launch of NittoPhaseHL – High Loaded Solid Support for Oligonucleotide Synthesis 3Kinovate Life Sciences, Inc. and Nitto Denko Corporation Announce Launch of NittoPhaseHL – High Loaded Solid Support for Oligonucleotide Synthesis 4WuXi PharmaTech Files 2009 Annual Report on Form 20-F 2
(Date:4/13/2015)... CHICAGO , April 13, 2015  higi, a ... with ways to more fully engage with their communities ... its industry-leading, privacy protected and secure API.  ... API enables the most accessible, affordable, and convenient vehicle ... The API will ...
(Date:4/2/2015)... , April 2, 2015 ... tests DERMALOG by far outperforms the strongest competitors, ... maintaining high accuracy, the system is capable of ... the speed proves up to be ten times ... than its runner-up performance.      (Photo: ...
(Date:4/1/2015)... Medisafe ™, the leading global medication management platform with ... Android smartphones and tablets, announces today that ... allow patients to track and correlate their adherence directly ... be able to visualize in real-time how taking medication ... glucose levels and blood pressure. "Patients need ...
Breaking Biology News(10 mins):higi Launches Seamless Access to HIPAA-Compliant Health Outcomes and Activity Data 2higi Launches Seamless Access to HIPAA-Compliant Health Outcomes and Activity Data 3DERMALOG AFIS Emerges as Performance Winner in NIST Benchmark Test 2DERMALOG AFIS Emerges as Performance Winner in NIST Benchmark Test 3Medisafe Announces Launch of Biometric Integration, Enabling Patients to Stay Adherent to Their Meds and See Tangible Health Results 2
... group of chemical compounds used by a species of ... promising antimalarial properties for humans. The compounds are part ... to battle enemies and that may provide a ... novel analytical process, researchers at the Georgia Institute of ...
... successfully being used in clinical trials to treat patients with ... die, it also forces them to release pro-inflammatory chemokines and ... attack the disease. New research published by BioMed Central,s open ... infected cancer cells secrete proteins which, even when isolated, result ...
... Variations in skin color provide one of the best ... body and should be used to teach evolution in schools, ... level of interest in skin color and for teachers, that ... Nina Jablonski, professor and head, Department of Anthropology, Penn State. ...
Cached Biology News:Antifungal compound found on tropical seaweed has promising antimalarial properties 2Antifungal compound found on tropical seaweed has promising antimalarial properties 3Antifungal compound found on tropical seaweed has promising antimalarial properties 4Skin color: Handy tool for teaching evolution 2Skin color: Handy tool for teaching evolution 3
... The high-performance triple quadrupole 1200L sets ... today's cost-conscious environment - incorporating the ... for all liquid chromatography analytical needs. ... interface and the Transmission Quadrupole Analyzer ...
Human GFR alpha-4 Affinity Purified Polyclonal Ab...
Human Siglec-9 Biotinylated Affinity Purified Pab...
Human MFRP MAb (Clone 291218)...
Biology Products: