Cleaning Validation for Drugs and Biologics Agenda

Untitled Document

10:00 a.m. – 10:10 a.m.

Introduction and Explanation of How a Virtual Conference Works

10:10 a.m. – 10:55 a.m.

Cleaning Validation: Current Regulations and Major Challenges
This presentation will discuss current regulations and proposed guidance that are in the making for cleaning validation and environmental monitoring. The first major step in creating a strategy designed to validate cleaning processes is evaluating process requirements and capabilities. This session will provide attendees with a rapid update and overview of the current regulatory horizon as well as address the first steps in creating a cleaning validation strategy.

Attendees will:

  • Review the regulatory requirements: cGMPs — 21 CFR Part 211, ICH Qs
  • Assess of trends in cleaning related 483’s and warning letters
  • Relate cleaning validation to the FDA’s new guidance on process validation

Rich Yeaton, President, East Coast Validation Services, LLC

10:55 a.m. – 11:40 a.m.

Setting Cleaning Validation Acceptance Criteria: A Risk Based Approach
When a validation run fails and a root cause analysis is performed it can often show that acceptance criteria are too rigid and are not scientifically based. By that time it is too late to start over and often resources must restart at the development phase. Subsequent processing steps must be taken into account when setting the acceptable criteria. This session will discuss how to set residue limits to develop cleaning acceptance criteria and teach attendees how to integrate sampling recovery factors.

Attendees will:

  • Calculate acceptable cleaning validation limits that meet regulatory requirements
  • Set appropriate limits for API, detergents, and cleaning agents
  • Integrate cleaning chemistry, parameters and engineering

Tony Polomene, Senior Cleaning Validation Specialist, Wyeth Biotech

11:40 a.m. – 12:00 p.m.

Break

12:00 p.m. – 12:45 p.m.

Utilizing A Quality by Design (QbD) Strategy for Cleaning Validation
Proper tracking is essential to the success of the cleaning method development and should include various techniques to ensure all peaks are tracked correctly. QbD provides a framework for implementing a systematic approach to process design, development and monitoring. This session will address the impacts of process parameters on product quality, and continually tracking, trending, and monitoring to assure consistent quality throughout the entire cleaning process.

                                               
Attendees will:

  • Streamline cleaning validation methods with a strong QbD strategy
  • Identify critical operating restrictions to set the most successful operating ranges
  • Apply the principles of QbD to cleaning validation using a real life case study

Greg Randall, Senior Principal Engineer, Baxter BioScience

12:45 p.m. – 1:30 p.m.

Cleaning Methods for Equipment Evaluation and Validation
In a recent warning letter, sent to Sumitomo Chemical, addressed a major problem with their equipment design of a tank that cannot be drained and has been in use since 1990. This enforcement action highlights the importance of equipment to be designed in a way that can be cleaned and validated. This session will describe the necessary design implications and requirements and implement a cleaning plan that will satisfy FDA inspectors during an inspection.   

Attendees will:

  • Integrate equipment design considerations that allow equipment to be cleaned
  • Consider engineering process while developing a validatable cleaning process
  • Evaluate sanitation processes of manufacturing equipment- Measuring and inspecting the cleanliness of equipment

Rebecca Brewer, Director, Validation & GMP Compliance, Dober Pharmaceutical Division

1:30 p.m. – 2:30 p.m.

Lunch Break

2:30 p.m. – 3:15 p.m. 

Contamination Control: Facility Design and Environmental Monitoring
Nowhere in drug manufacturing does the risk of contamination carry such a high price as in sterile operations. Failures in contamination control often lead to exhausting resources and cause many complications. The consequences are likely to be severe and can include production loss, regulatory enforcement actions and loss of consumer confidence. This session will addresses facility cleaning and design and how they impact environmental control.

Attendees will:

  • Define and establish cleaning facility acceptance criteria
  • Integrate cleaning facility methods within an environmental monitoring program
  • Create a program that catches potential facility contamination hot spots

Rich Yeaton, President, East Coast Validation Services, LLC
with the assistance of
Jesse Coiro, Consultant, UniClean Cleanroom Services

3:15 p.m. – 4:00 p.m.

Inspectional Readiness: Preparing Compliant Cleaning Validation Documents
Cleaning validation provides evidence that cleaning processes are effective and demonstrate consistent capability of removing potential contaminants that meet predetermined levels of cleanliness. The FDA requires that firms provide accurate documentation as proof that cleaning processes are effective and training requirements have been met. This session will detail required documentation including the cleaning validation master plan, final reports, analytical data and cleaning process SOPs.   

Attendees will:

  • Create a cleaning validation master plan: using proper content and organization including training documentation
  • Prepare required documentation for cleaning processes, sampling locations and cleaning agents
  • Effective deviation resolution for program closure and final report completion
  • Theoretical Case study: Executed protocol, analytical data and summary report

Kathy Eley, Principal, KAE Validation Services, LLC

4:00 p.m. – 4:15 p.m.

Chairperson’s Closing Comments and Adjournment


 
How does this virtual conference work?

The Cleaning Validation for Drugs and Biologics Strategies for Managing Your Biggest Compliance Challenge Virtual Conference takes all the best elements of the best live conference you’ve attended and avoids all the negatives. It delivers valuable clinical trial development intelligence using the internet for visual components and your speakerphone for the accompanying audio.

All you do is go to the specified website on the day of the event and dial the specified toll-free telephone number, both provided in your registration confirmation. That’s all there is to attending.

Then, relax at your desk or in your conference room, enjoying summit sessions featuring PowerPoint slide presentations, helpful handouts and Q&A opportunities where specific attendee questions will find direct answers from leading supply chain professionals.

What are the top benefits of a virtual conference?

Highly effective communication: This event uses internet and audioconferencing to create a seamless interface and deliver vital compliance and management advice using technology found in every workplace.

Great value: Select as many of your colleagues to attend as you wish and educate everyone for one low price, with no travel, lodging or per diem expenses.

Stress-free: No hotel or airport nightmares because you never have to leave your building. You’ll feel like you’re off-site at a top-flight conference, until you realize how easy it is to get things done during breaks.

Efficient: You can assign your staff to different sessions.  Staffers can go to the sessions that most pertain to their responsibilities.

Content-rich: This virtual conference addresses your most challenging, complex and frustrating supplier quality problems.

Interactive: No one-way street, you’ll have plenty of opportunities to ask questions and get involved.

Up to the minute: This program will be up to the minute with the latest changes initiated by the FDA and international regulatory bodies incorporated into the event.

Comprehensive: You’ll hear from six industry experts all in the course of one day.