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
Promising Drug Candidate to Treat Chronic Itch
In a new study, scientists from the Florida campus of The Scripps Research Institute (TSRI) describe a class of compounds with the potential to stop chronic itch without the adverse side effects normally associated with medicating the condition.
Are Changes to Current Colorectal Cancer Screening Guidelines Required?
Editorial suggests more research is needed to pinpoint age to end aggressive screening.
Assessing Cancer Patient Survival and Drug Sensitivity
RNA editing events another way to investigate biomarkers and therapy targets.
New Molecular Marker for Killer Cells
Cell marker enables prognosis about the course of infections.
Potential Target for Treatment of Autism
Grant of $2.4 million will support further research.
Sniffing Out Cancer
Scientists have been exploring new ways to “smell” signs of cancer by analyzing what’s in patients’ breath.
Inroads Against Leukaemia
Potential for halting disease in molecule isolated from sea sponges.
Molecular ‘Kiss Of Death’ Flags Pathogens For Destruction
Researchers have discovered that our bodies mark pathogen-containing vacuoles for destruction by using a molecule called ubiquitin, commonly known as the "kiss of death."
A New Single-Molecule Tool to Observe Enzymes at Work
A team of scientists at the University of Washington and the biotechnology company Illumina have created an innovative tool to directly detect the delicate, single-molecule interactions between DNA and enzymatic proteins.
Milestone Single-Biomolecule Imaging Technique May Advance Drug Design
The first nanometer resolved image of individual tobacco mosaic virions shows the potential of low-energy electron holography for imaging biomolecules at a single particle level; a milestone in structural biology and a potential new tool for drug design.
Scroll Up
Scroll Down

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
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos