Cleaning Validation Summit 2024 - uventia

Cleaning Validation Summit 2024

Cleaning-Validation-Summit
Event Details

CONFERENCE OVERVIEW

Drug products and active pharmaceutical ingredients (APIs) may be contaminated by other drug products or APIs, raw materials, intermediates, cleaning aids, microorganisms, particles and other materials. Contamination causes costly raw materials to be scrapped, triggers regulatory actions and, most importantly, endangers the safety of patients.

In order to avoid contamination of the product, robust cleaning procedures must be performed. Our online meeting facilitates peers’ reflection and discussion on approaches to establishing and revising CV programs to meet regulatory requirements, verifying CV protocols and preventing ineffective or incorrect approaches to cleaning validation programs, risk based cleaning validation, selecting the right equipment/cleaning procedure combinations, testing for API residues and calculating residue limits, considerations on combining cleaning and sanitization, finding and developing practical analytical methods and sampling procedures.

Be a part of our webinar sessions to build practical and compliant cleaning validation program and ensure that the quality of your next product is not affected by contamination.

WE WILL BE FOCUSING ON

  • QRM in Cleaning Validation
  • Cleaning Validation in shared facilities
  • Product bracketing and equipment grouping during Cleaning Validation
  • CIP Cleaning process optimization and sustainability
  • Maintaining the Cleaning Validation program
  • Regulatory and GMP aspects for Cleaning Validation
  • Developing suitable analytical methods
  • Sampling methods and sampling recoveries
  • Establishing acceptance limits
  • Selection of Cleaning agents
  • Visual inspection for Cleaning Validation
  • Microbiological aspects of Cleaning Validation

WHO IS IT FOR?

CxO, VP, Directors, Heads, Managers of

  • Cleaning Validation/ Containment
  • Bioprocessing/ Bioproduction
  • Aseptic Processing/ Sterility Assurance
  • Manufacturing Science & Technology/ Good Manufacturing Practice (GMP)
  • Cleaning Products/ Detergents
  • Risk Management/ Quality Assurance/ Quality Control
  • Analytical Development/ Analytical Methods
  • Regulatory Affairs/ CMC
Agenda-CV

[Agenda] Cleaning Validation Summit 2024

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.

Speaking Companies

Speaker Board
Jenna Carlson
President & Quality Consultant
Mindful Quality
Brian Bosso
Technical Service Manager
STERIS Corporation
Brook Meadows
Senior Technical Service Associate
STERIS Corporation
William A. Hawkins
Managing Toxicologist
SafeBridge, Europe
Tara Dennis
Occupational Hygiene Manager
SafeBridge, Europe
Mariann Neverovitch
Sr. Manager Logistics Operations
Bristol-Myers Squibb
Fred Ohsiek
Principal Cleaning Process Consultant
VTI Life Sciences

Summit Agenda

◆  Preliminary risk assessment.

◆  Equipment design.

◆  Grouping of products and equipment, worst-case combinations.

◆  Matrix approach to streamline cleaning validation.

◆  Cross-contamination control and HBELs setting.

◆  Cleanability studies, cleaning validation and verification.

◆  Safety thresholds for biologics, cytotoxic and genotoxic compounds.

◆  Qualification of manufacturing equipment.

◆  Bracketing and grouping regulatory expectations.

◆  Common mistakes and misconceptions when bracketing and grouping.

◆  Science and risk-based approaches when grouping.

◆  Equipment grouping case study.

◆  CIP cleaning recipe.

◆  Elements of an optimized cleaning process.

◆  How to efficiently optimize a CIP cleaning process.

◆  Hidden benefits of optimizing legacy cleaning process.

◆  Explore cleaning development sampling strategy.

◆  Efficient restart after a shut-down and cleaning after maintenance.

◆  When re-validation makes sense.

◆  Explore process for creating an efficient and robust science risk-based CPV program.

◆  Routine monitoring case study.

◆  Protocol reporting and validation compliance.

◆  Regulatory emerging trends for industry.

◆  EMA and FDA guidelines.

◆  PIC/S, ICH guidelines.

◆  Current Health Agency observations & warning letters related to cleaning.

◆  Specific vs non-specific methods.

◆  Analytical methods to detect active ingredients, byproducts and degradation products, cleaning agent residues, bioburden and endotoxins.

◆  Validation of analytical methods.

◆  Contact vs non-contact surface areas.

◆  Sampling plan and acceptance limits.

◆  Risk-based surface sampling.

◆  Surface sampling recovery studies.

◆  Swabbing, rinse water and coupon sampling methods.

◆  Acceptance criteria based on toxicity data (NOAEL, ADE/PDE, TTC).

◆  MACO levels for worst-case product.

◆  Challenges of establishing residual limits.

◆  Identifying the hazards with contamination data.

◆  Cleaning agents based on cleanability studies, cleaning method, supplier qualification.

◆  Rinsability of cleaning agents.

◆  The safety of cleaning agent.

◆  Limit calculations for cleaning agent residues.

◆  Benefits and limitations of visual inspection (VI).

◆  Establishing visual residue limits (VRL).

◆  Qualification of personnel and visual inspection training.

◆  Visual inspection, surface sampling and rinse sampling.

◆  Risk assessment and management as justification of VI.

◆  Equipment Cleaning is a critical GMP element of the Manufacturing Process. It ensures quality and safety of future batch. Cleaning Validation/verification is a measurement of the effectiveness of the cleaning process.

◆  In this presentation we will go over advantages and challenges of specific and non-specific analytical methods based on risk assessment of the residual product.

◆ Case studies, training and qualification programs will also be discussed.

◆  Direct and indirect risks from microorganisms.

◆  Evaluating microbiological risks.

◆  Establishing microbiological sampling plan.

◆  Microbiological testing and acceptance criteria.

Event Details