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CONTAMINATION CONTROL

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September 24

San Francisco, United States

Developing a Risk-Based Program

 

COURSE DESCRIPTION:

Contamination control is critically important in drug manufacturing. Implementation of a robust contamination control strategy is a key regulatory requirement for operating in a cGMP environment. This contamination control event will provide you with a blueprint for developing and implementing a risk-based contamination control strategy. Attendees will learn about best practice cleaning and disinfection strategies and regulatory compliance.

 

Top 10 Reasons to Attend:

  1. Establish the steps to develop a contamination control strategy for your organization
  2. Understand the current regulatory landscape and how it impacts your business
  3. Identify the impact Annex 1 has on your sterile environment
  4. Design the main steps involved in the validation of a disinfection process
  5. Understand what a residue is and how to effectively design a program to remove it
  6. Engage and interact with industry experts on their cleaning and disinfectant program models
  7. Study all the most recent changes to Annex 1
  8. Launch a risk assessment for the identification of contamination risks present in your facility
  9. Analyze various types of efficacy testing and their potential impact on your program
  10. Reduce validation timelines and costs by analyzing a harmonized approach to disinfectant efficacy

 

Personnel in the Following Environments Should Attend:

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

 

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

Agenda

  • l.
    Contamination Control Strategy Using a Risk-Based Approach
    This presentation describes key considerations for designing a cleaning/disinfection regime. It provides rationale for using a risk-based approach according to the grade of area (e.g. product selection, application method, consideration of EM data etc.).
  • ll.
    The New GMP Annex 1 - Likely Impact on Cleaning and Disinfection
    This presentation explores the proposed changes introduced in the new Eudralex GMP Annex 1 (manufacture of sterile medicinal products). It addresses rationale for the changes and recommendations to ensure compliance. Areas of focus include rotation, in-house preparation, hold times, cleaning, residues and validation.
  • lll.
    Using a Harmonized Approach to Disinfectant Efficacy
    The purpose of this presentation is to detail essential considerations in development of a disinfection validation plan that stands up to regulatory scrutiny.
  • lV.
    An Improved Approach to Cleanroom Disinfection, Minimizing the Impact and Reducing Downtime
    Managing residues in a cleanroom environment is critical to regulatory compliance and maintaining a well-controlled production environment.
  • V.
    Workshops for Effective Cleaning and Disinfection (Speaker Panel)
    Participants apply knowledge to design an effective disinfection regime.
  • 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

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Details

Date:
September 24
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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