Corporate Banner
Satellite Banner
Biologics & Bioprocessing
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
Breakthrough Flu Vaccine Inhibited by Pre-existing Antibodies
Universal truths – how existing antibodies are sabotaging the most promising new human flu vaccines.
Zika Vaccine Candidates Show Promise
Two experimental vaccines have shown promise against a major viral strain responsible for the Brazilian Zika outbreak.
NIH Begins Yellow Fever Vaccine Trial
NIH has initiated an early-stage clinical trial of a vaccine to protect against yellow fever.
Antibody Drug Shows Promise in HIV Treatment
Researchers are a step closer to an alternative HIV treatment that has the potential for lasting effects and less frequent dosing.
Flu Vaccine May Reduce Risk of Death For Type 2 Diabetes Patients
Researchers at Imperial College London have suggested that the vaccine may have substantial benefits for patients with long-term conditions.
Flu Vaccine May Reduce Death Risk of Type 2 Diabetes
New research suggests that a new flu vaccine may reduce probability of type 2 diabetes patients being hospitalised with stroke and heart failure.
Disrupting Tumour-Promotion in Humans
Researchers have modified an existing protein to represses a specific cancer-promoting ‘message’ within cells.
Protein Nanocages Could Improve Drug Design and Delivery
HHMI scientists have designed and built 10 large protein icosahedra that are similar to viral capsids that carry viral DNA.
Vaccine Strategy Targets Multiple Influenza Viruses
Scientists have identified vaccine-induced antibodies that can neutralize strains of influenza virus that infect humans.
Antibody-Based Drug for Multiple Sclerosis
New antibody-based drug paves the way for new strategies for controlling and treating multiple sclerosis.
Scroll Up
Scroll Down
Skyscraper Banner

SELECTBIO Market Reports
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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!