Developing a contamination control strategy to meet EU GMP Annex 1 requirements

Duration: 60 Minutes
Contamination control is an important part of both sterile and non-sterile pharmaceutical manufacturing, regulators, as signaled by the revised EU GMP Annex 1 and from FDA inspections are increasingly expected the contamination control to be devised and presented as a formal program. This means a detailed, facility-specific contamination control strategy. This webinar sets out the key elements of the strategy. To be effective, this needs to be an approach that can assess seemingly isolated contamination events holistically and which is capable of putting appropriate corrective and preventive actions (CAPAs) in place. This approach signals a new paradigm in terms of contamination control, shifting the risk review process to one that assesses the impact of a contamination event in a far wider context.
Developing a contamination control strategy
Instructor: Tim Sandle
Product ID: 503283
Objectives of the Presentation
  • How to design a contamination control strategy
  • The format of a contamination control strategy
  • The review period for a contamination control strategy
  • How to ensure that the contamination control strategy is holistic in nature
  • How to incorporate risk management into the strategy
  • How to capture advances in manufacturing technology
  • What the revised EU GMP Annex 1 additionally requires
Why Should you Attend
Each pharmaceutical manufacturing facility should have a holistic contamination control strategy in place. However, it is not clear what this strategy should contain and what is required by regulators. This webinar provides an overview of the key points expected in a contamination control strategy, as well as the form such a strategy should take and how often the strategy needs to be reviewed.

Areas Covered
  • Understanding the design of both the plant and process
  • Detail of equipment and facilities
  • Raw Materials Control
  • Microbial control
  • Environmental monitoring
  • In-process controls
  • Product containers and closures
  • Vendor approval
  • Outsourced services
  • Process risk assessment
  • Process validation
  • Cleaning and disinfection
  • Monitoring systems
  • Contamination prevention measures
  • Continuous improvement
Who will Benefit
  • Microbiologists
  • Microbiology managers
  • Quality Control
  • Quality Assurance
  • Compliance
$299
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $379.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $429.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle's current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.
View More