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
Molecular Mechanism For Generating Specific Antibody Responses Discovered
Study could spur more ways to treat autoimmune disease, develop accurate vaccines.
Understanding Female HIV Transmission
Glowing virus maps points of entry through entire female reproductive tract for first time.
Soy Shows Promise as Natural Anti-Microbial Agent
Soy isoflavones and peptides may inhibit the growth of microbial pathogens that cause food-borne illnesses, according to a new study from University of Guelph researchers.
Designing Better Drugs
A rational drug engineering approach could breathe new life into drug development.
AstraZeneca to Sequence 2 Million Genomes in Search for New Drugs
Company launches integrated genomics approach which aims to transform drug discovery and development.
Factors Influencing Influenza Vaccine Effectiveness Uncovered
The long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited, new research suggests.
Study Finds Factors That May Influence Influenza Vaccine Effectiveness
Researchers at NIH have suggested that the long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited.
New Model to Enhance Zika Virus Research
The model will allow researchers to better understand how the virus causes disease and aid in the development of antiviral compounds and vaccines.
Improving Flu Vaccine Effectiveness
NIH study finds factors that may influence influenza vaccine effectiveness.
BMS’s Opdivo Clinical Trial Shows Promise
Safety profile of the combination regimen from CheckMate -069 was consistent with previously reported studies and adverse events were managed using established safety algorithms.
Scroll Up
Scroll Down
SELECTBIO

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
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!