Confluent Translations is excited to exhibit at the conference being held February 5-7, 2013. This is Cambridge Healthtech Institute's Fourth Annual Summit for Clinical Ops Executives, taking place in Miami, Florida.
GlobalCompliancePanel, a leading regulatory and compliance training gateway, will host a two-day, in-person seminar on the topic, "Good Laboratory Practice Regulations -Introduction and Strategies for Implementation" on March 21 and 22 at Mumbai, India.
When preparing statistics for Quality Control and Process Validation, professionals are required to compare various sets of data. In this series on this topic, the expert, Dr. Steven Kuwahara has already covered the area of converting the process for comparing two sets of data.
Data from testing and measuring usually follow mathematical distributions other than normal distribution, or what is called the Bell-Shaped curve. Among these, the Poisson Distribution, which describes low frequency events, occupies a prime place.
According to a new technical market research report, THERAPIES AND BIOMARKERS FOR INFLAMMATORY BOWEL DISEASE (PHM125A), from BCC Research (www.bccresearch.com), the market for inflammatory bowel disease therapeutics was valued at $4.8 billion in 2011 and should reach nearly $5.1 billion in 2012.
There are several methods to trend data to highlight both the preventative and corrective nature of the system. Plotting data over time is a good visual method to identify trends. Statistical Process Control (SPC) techniques such as control charts give an objective method to identify trends.
Retention of records pertaining to drugs is a major issue in the drug industry. There is a lot of debate, discussion and even confusion on the period of time for which records need to be kept.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a webinar on the topic; "Good Documentation Practice for GxP Environments"on January 15.John R. Godshalk, Senior Consultant at Biologics Consulting Group will be the Speaker at this session.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a webinar on the topic, "Complaint Handling and Management: From Receipt to Trending", on January 15.
AdvantaPure(R) now offers a fabric and wire reinforced hose made from platinum-cured silicone for high purity applications such as biopharmaceutical, pharmaceutical, and food. The hose, called APSW, is crush and kink resistant and handles both pressure and full vacuum. APSW meets standards from organizations such as USP, FDA, European Pharmacopoeia, ISO, 3-A, and NSF.
This webinar will examine the FDA's recently instituted annual "Strategic Priorities" initiative, with emphasis on 2013. Such a review will focus on the broad range of issues a company's senior management and QA-RA need to consider in their annual Management Review of their existing quality management system.
The Berlin-based clinical contract research organization (CRO) ICRC-Weyer GmbH is adapting a process of integrating medical review procedures into Pharmacovigilance risk management, a method that will lead to better Pharmacovigilance practices.
Regulatory agency audits are designed to evaluate your company's regulatory risk profile. In order to comply with GMP regulations, companies are required to self regulate their operations through regularly scheduled internal audits. Regulations also require the company's senior management be involved with these audits.
"GMP Expectations for Products Used in Early Phase IND Studies" is the topic of a 90-minute, RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on December 18. This webinar, at which Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will be the speaker.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize aRAPS pre-approved webinaron November 15.This course earns up to 1.5 RAC credits towards a participant's RAC recertification upon full completion. Jeff Schwegman, Ph.D., founder and chief executive officer of AB BioTechnologies,will be the Speaker at this session.
ICRC-Weyer GmbH, a clinical contract research organization (CRO) based in Berlin, Germany, has released its review of the year 2012, stating it has been a successful and exciting 12 months for everybody involved in the business. The company looks forward to more constructive partnerships and growth for the year ahead.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organizea RAPS pre-approved webinaron the topic, "Changes to Good Pharmacovigilance Practices in the EU"onDecember 13.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Cost-Effective Computer System Validation: Step-by-Step" on December 13. This 75-minute webinar earns up to 1.25 RAC credits towards a participant's RAC recertification upon full completion.
"Establish and Maintain an Effective Supplier Qualification Program" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organizeon December 13.David R. Dills, Regulatory and Compliance Consultant, will be the Speaker at this session.
"Responding to FDA 483's" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on December 11.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organizea RAPS pre-approved webinar on the topic, "510(K): Format and Contents", on December 11.Dr. David Lim, a certified RAC and Certified Quality Auditor (CQA), will be the speaker at this webinar, which earns up to 1.00 RAC credits a participant's RAC recertification upon full completion.
A RAPS pre-approved webinar on the topic, "Human Behavior in Cleanrooms and Controlled Environments" is being organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider on December 11. This webinar earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion.
"Root Cause Analysis and Documentation Requirements for CAPA" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on December 6. This webinar earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion.
David Nettleton, FDA Compliance Specialist, will be the speaker at aRAPS pre-approved webinaron the topic "Excel Spreadsheets -Step-By-Step Instructions for Compliance" that is being organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider,on December 5.
A RAPS pre-approved webinar on the topic, "Change Control - Key to Successful cGMP Compliance" is being organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, on December 5. This webinar earns up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.
"Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner" is the topic of a 60-minute, RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on December 4. This webinar, which earns up to 1.00 RAC credits towards a participant's RAC recertification.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organizea RAPS pre-approved webinar o the topic,"FDA Inspections - Do's and Don'ts" onSeptember 25. Jeff Kasoff, RAC, Director of Regulatory Affairs at Life-Tech, Inc., will be the speaker at this 60-minute webinar.
A RAPS pre-approved webinar on the topic, "21 CFR Part 11: Auditing for Part 11 Compliance" is being organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, on December 4. This webinar earns up to 2.00 RAC credits towards a participant's RAC recertification upon full completion.
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