Corporate Banner
Satellite Banner
Biomolecular Screening
Scientific Community
 
Become a Member | Sign in
Home>Events>This Event
  Events - April 2014


Writing effective SOPs and Good Documentation Practice

10 Apr 2014 - 11 Apr 2014 - BioCity Edinburgh, UK



Bookmark and Share


Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. Standard Operating Procedures (SOP’s) provide the main forum for the documentation of a Company’s systems and operations. SOP’s are therefore the most popular documents audited by Regulatory Agencies during GMP inspections and all too often they result in observations. This course provides helpful information by presenting topics associated with the writing, formatting, execution and management of SOP’s that contribute to consistent and efficient operations. It also discusses good documentation practices required by companies to ensure GMP compliance and relates the role which SOP’s play in achieving the required level of compliance and quality. This course is designed to assist with writing effective SOPs which contribute to the overall compliance of a company. What regulatory inspectors look for in SOPs, Good Documentation Practices, Global Harmonization of SOPs and maintenance of the SOP system though change control are also discussed. * Regulatory inspectors expectations for SOPs * The role of SOP’s with respect to GMP operations, global harmonization, documentation and document control. * Good Documentation Practices * Reviewing current SOP’s to determine gaps and overlaps to strengthen the existing documentation system. * Maintenance of SOPs * Designing an SOP template to optimize efficiency of organization and formatting of SOP’s * The team approach to SOP writing, defining responsibilities and knowing the audience. * The importance of capturing the actual flow of an operation within the document * Writing tips on how to keep the document concise, unambiguous and accurate. * Training of SOP documents * Managing revisions and deviations through a document Change Control System

Further information
Scientific News
Mass Spec Technology Drives Innovation Across the Biopharma Workflow
With greater resolving power, analytical speed, and accuracy, new mass spectrometry technology and techniques are infiltrating the biopharmaceuticals workflow.
One Step Closer to Precision Medicine for Chronic Lung Disease Sufferers
A study led by University of North Carolina at Chapel Hill, and National Jewish Health, has provided evidence of links between SNPs and known COPD blood protein biomarkers.
CES Score May Predict Response to Cancer Treatment
Researchers identify new type of biomarker that helps predict prognosis and response to several types of cancer treatment.
Treating Sepsis with Marine Mitochondria
Mitochondrial alternative oxidase from a marine animal combats bacterial sepsis.
New Therapeutic Target for Crohn’s Disease
A promising new target for drugs that treat IBD has been identified along with a possible biomarker for IBD severity.
Researchers Find Fungus-Fighting Compound
A compound has been identifed that blocks growth of a fungus responsible for lung infections and allergic reactions.
Analysing 10,000 Cells Simultaneously
New techniquethat traps 10,000 cells on a single chip has potential for cancer screening for individuals.
Peer Reviewed Study Demonstrates Mass Spec Technique
The peer reviewed study demonstrates MS workflow, TMTCalibrator workflow, which dramatically enhances detection of key early stage Alzheimer’s biomarkers.
Small Molecules Lead to a Big Change in Reaction Outcomes
Scientists have changed the behaviour of a group of molecules involved in carbon-oxygen bond synthesis.
Enhancing Antibiotics to Defeat Resistant Bacteria
Scientists enhance ability of antibiotics to defeat resistant types of bacteria using molecules called PPMOs
Scroll Up
Scroll Down
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!