Writing SOPs - Workshop
Lecturer: Ms. Karen Ginsbury
Location: On Site
Course Language: English
 
Category:  GMP ,
Quality
Course Name: Writing SOPs - Workshop
Duration: Day Course
Hours: 9:00am - 5:00pm
Credit Points: 0
Course ID : A11169

One of the most common audit findings is "lack of SOP to describe the activities relating to……" or "the SOP for ______ does not address the responsibilities of ______"
This workshop will help you ensure compliance with cGMP / QSR / GLP / GCP regulations by writing procedures that address all aspects of the procedure to be performed.

Objective of the workshop:
To review the purpose of SOPs and to provide participants with tools to write their own SOPs that are clear, concise and not open to interpretation.  The course will include group exercises and participants will take home an SOP that they have prepared
Benefits to the Participants
  • Understanding of the need for writing SOPs to cover all significant activities within the company
  • Understanding of the way a procedure should be written
  • Learning how to discard irrelevant details and focus on the important aspects of the procedure, emphasizing them while describing them in precise but concise terms
Issues to be covered
  • Background to regulation: what happens when instructions are unclear
  • Warning letters and 483 findings concerning inadequate SOPs (examples from GMP, QSR, GLP and GCP
  • What should an SOP include:o Main headings and formato Purpose of each SOP:
    • how to define ito Responsibilities:
      • who is responsible for what and how to define shared responsibilitieso
    • The actual procedureo Restrictions: what should not be done and what to do if (special cases)
    • Corrective action: what to do when it goes wrongo Documentation: what records should be generated as a result of writing this procedure

Reviewing and editing SOPs for accuracy and content
Exercise Participants will work in break out groups to develop an SOP on a particular topic.  The procedure will be discussed with the class and reviewed and edited so that it can be taken home for use in your company.

Please note that this workshop will not address:
Preparation of analytical test methods or preparation of validation protocols

This 3-days course includes a 1-day “Writing SOPs” Workshop
Separate Registration is available for the 1-day “Writing SOPs” Workshop
About the Speaker
Karen Ginsbury, B.Pharm, M.Sc, MRPharmS, has over twenty years of experience in the pharmaceutical industry.  With a Bachelor of Pharmacy degree from the University of London (“The Square”) and a Master of Science in Microbiology from Birkbeck College, University of London, Karen started off with a well-rounded foundation in the basic skills appropriate to the pharmaceutical industry.  She has worked in industry for most of her career, initially in Research and Development at Smith and Nephew in England and then for seven years at Teva Pharmaceutical Industries, today the world’s largest generic manufacturer.  After leaving Teva, Karen set up her own consultancy company, PCI Pharmaceutical Consulting Israel Ltd which has been providing services to the pharmaceutical industry worldwide for the past 14 years.  PCI regularly works with pharmaceutical, biotech and API manufacturers to assist them in resolving compliance issues with regulatory authorities, in setting up, maintaining and upgrading or improving their quality systems, performing audits at vendors, contract manufacturers, laboratories as well as helping clients successfully prepare for FDA, Health Canada, EU and local regulatory inspections.
Karen was responsible for setting up the compliance department at Teva and published a book on compliance auditing, still available in the USA, that was purchased by most of the multi-national pharmaceutical companies as well as by the US FDA.
Karen regularly lectures around the world on quality topics and is renowned for her lively and engaging style of presentation.  She was winner of the Institute of Validation Technology’s “Presentation of the Year Award” in 2006 and their “Webseminar of the Year Award” in 2007.
Karen is also an active volunteer in the Parenteral Drug Association (PDA) and is currently co-editing their Technical Report on GMPs for Investigational Products.