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ADVANCED CONTAMINATION CONTROL

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September 25

San Francisco, United States

Tools, techniques, and SOPs for Disinfectants and Biodecontamination

 

COURSE DESCRIPTION:

Regulators have had a more holistic approach to contamination control strategies related to the lack of SOPs for a clear contamination control strategy. In this course, you’ll focus specifically on how to incorporate sporicidal disinfection into your program and learn about the role that isolators play in your contamination control strategy. Then, using a hands-on approach, instructors will guide you through the most effective cleaning and disinfectant application techniques.

 

Top 10 Reasons to Attend:

  1. Interact with instructors to ensure effective cleaning and disinfection techniques are being used at your company
  2. Analyze your mopping system and how it should meet respective purity requirements, and not adversely affect the production process
  3. Evaluate best practices for surface disinfection
  4. Build a well-defined residue removal program that can be implemented at your organization
  5. Identify current changes to the standards relating to the transfer disinfection process
  6. Review advantages and disadvantages of isolator configurations
  7. Analyze personnel conduct and how cleanroom risk can be minimized by the severe limitation of human interaction
  8. Share knowledge with industry peers and review real world case studies
  9. Review recent 483 observations and Warning Letters that address spore control
  10. Break down the facts regarding gaseous decontamination

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • Regulatory Affairs
  • Compliance
  • Manufacturing
  • Laboratory

 

***Attend this event along with Contamination Control and save $200.00!  Select the dual event ticket type for $1790.00 to register for both seminars and save!***

Agenda

  • l.
    Overcome the Challenge of Bacterial Endospores
    Understand the risks posed by bacterial spores and fungal spores
  • ll.
    Incorporate a Strategic Approach to Isolator Technology
    Review myths and legends of isolator and gaseous decontamination.
  • lll.
    Hands-On ½ Day
    The objective of this session is to provide participants with a hands on experience for learning optimal cleaning and disinfection techniques. Participants have the opportunity to submit specific questions and cleaning problems in advance of the hands-on session so that the instructors can provide tailored instruction.

Faculty

  • Matt Cokely, Global Technical Consultant, Ecolab Life Sciences

    Matt has 15+ years experience within the pharmaceutical industry working as a pharmaceutical microbiologist. He has experience working in graded cleanrooms and in the manufacture of a wide and diverse range of pharmaceutical formats including solid oral dosage units, oral liquids, powders and sterile injectable products. Matt is an invited speaker on international contamination control and regulatory compliance topics, and is a co-opt committee member of the Parenteral and Healthcare Sciences Society (PHSS). He is an IRCA-certified Pharmaceutical Quality Management Systems (PQMS) GMP Provisional Auditor (certification number 6038029) and is completing a CPD log to advance to ‘auditor’ level.
  • Luke Durr, Validation Manager, Bioquell Inc.

    Luke Durr holds a degree in Biomedical Engineering with a concentration in biomaterials from Rensselaer Polytechnic Institute (RPI). In his role as Validation Manager with Bioquell Inc., Luke has worked with countless pharmaceutical and healthcare clientele to improve their contamination control programs. Luke works closely with various regulatory agencies including the FDA, EPA and NSF serving as an expert in hydrogen peroxide vapor decontamination technologies.
  • Madison Hoal, Global Technical Consultant, Ecolab Life Sciences

    Madison is a pharmaceutical microbiologist who has experience in the manufacture of a range of pharmaceutical formats including non-sterile liquids, topicals, and sterile injectables. Madison’s experience includes working with a team to design and qualify a clinical drug product manufacturing facility. She has experience developing an environmental monitoring program for an ISO classified aseptic manufacturing facility and established an on-site microbiology laboratory. She has also been responsible for site-wide aseptic operations training and gowning qualification programs. Madison has led numerous investigations into environmental monitoring non-conformities utilizing risk management to identify and mitigate contamination risks. She has implemented important changes to facility design, procedures, and personnel training to optimize the process and minimize contamination risks.
  • Ed C. Tidswell, PhD, BSc Merck

    Dr. Tidswell is Executive Director within the Sterile and Microbiology QA organization of Merck. This role has ownership over microbiology issues across sterile and non-sterile sites within the Global Manufacturing Division. His prior appointments include global R&D, and quality leadership roles supporting and innovating across large volume parenteral, small volume parenteral (small molecules, biologics, vaccines), medical device and bulk active pharmaceutical ingredient manufacturing and testing platforms for the likes of Baxter Healthcare, Eli Lilly and Evans Vaccines. Dr Tidswell continues to actively publish and is a leading authority on pharmaceutical microbiology, risk, aseptic and sterile manufacture. From 2013 he has served on the PDA’s Science Advisory Board and is currently a member of the PDA Journal’s Editorial Board. In June 2010 Dr. Tidswell joined and continues to serve on the USP expert committee on Microbiology & Sterility Assurance.

Sponsors

  • Ecolab is the global leader in water, hygiene and energy technologies and services. Every day, we help make the world cleaner, safer and healthier – protecting people and vital resources.
    Website: https://www.ecolab.com/

Partners

    More Information To Follow Soon

Venue

Details

Date:
September 25
Event Category:

Venue

Kimpton Sir Francis Drake Hotel
450 Powell Street
San Francisco, 94102 United States
+ Google Map
Phone:
800-795-7129
Website:
https://www.sirfrancisdrake.com/

Pricing & Registration

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