Regulatory Requirements and Principles for Cleaning Validation: 2-Day In-person Seminar training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Regulatory Requirements and Principles for Cleaning Validation: 2-Day In-person Seminar  

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Senior quality managers, Quality professionals, Production supervisors, Validation engineers, Process owners, Quality engineers, Quality auditors

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Seminar Summary:

This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. (see full course description)

 

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Training Course Syllabus:


Regulatory Requirements and Principles for Cleaning Validation: 2-Day In-person Seminar

Course Description:

This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.

The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a "Cleaning Validation Master Plan" and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.

Topic Background:

Cleaning validation programs for pharmaceutical firms are a regulatory expectation. The FDA, Health Canada, WHO and other regulatory agencies have published their expectations for a good cleaning validation program. There are also numerous textbooks, articles, and other helpful resources such as PDA’s Technical Report #29 (Revised 2012) “Points to Consider for Cleaning Validation”. The risk-based regulatory initiatives of the FDA focus new attention on the risks of cross-contamination. Some firms have highly potent molecules in their product mix. Advanced analytical methods are emerging with promises to detect molecules to the ppb levels. Understanding and implementing new technologies and principles pause challenges to a cleaning validation specialist to establish, manage and maintain a scientifically sound cleaning validation program.

This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.

Learning Objectives:

By the end of this course attendees will:

Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product
Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections
Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies

Course Outline:

DAY ONE (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

9.00 am – 10.00 am: FDA Requirements and Industry Standard Practices

Regulatory requirements, Guidelines, & Expectations

Industry standards of cleaning

10.00 am – 10.45 am: How to Develop/Review your Cleaning Procedures and the Adequate Selection of Cleaning Agents and Parameters

CIP, COP, Manual Cleaning procedures – advantages and disadvantages

Selection of Cleaning Agents for your equipment/product and adequate Parameters to provide best results

10.45 am – 11.00 am: Break

11.00 am – 12.00 pm: How to Develop a Cleaning Validation Policy/Program

Why do you need a policy/program?

Key elements of a policy/program

12.00 pm – 1.00 pm: Lunch

1.00 pm – 2.00 pm: How to Implement a Robust Cleaning Validation Plan

The information gathering process Review of cleaning processes/procedures Analytical Method development and validation

Use of the risk assessment concept to identify worst case products & equipment

How to select challenge conditions and determine acceptance criteria and preparation of a product/equipment matrix

2.00 pm – 2.45 pm: How to Implement a Robust Cleaning Validation Plan

Health based and adulteration based limits calculations

Use of visual criteria for determining if equipment is clean

Concepts of clean hold time (CHT) and dirty hold time (DHT)

Choice of sampling type (swab versus rinse), sampling protocols, use of digital photographs, & sampling rationale

Documentation requirements – protocols, deviations and final reports

2.45 pm – 3.00 pm: Break

3.00 pm - 3.30 pm: Laboratory Issues in Cleaning

Suitable sensitivity and specificity issues

Recovery studies

Training of samplers and sampling technique

3.30 pm – 4.15 pm: Microbiological aspects of a cleaning validation program for manufacturing equipment:

Cleaning after use versus sanitization before use

Typical sanitization procedures

Testing requirements

4.15 pm – 4.30 pm: Questions/Answers/Comments

DAY TWO (8:30 AM – 4:30 PM)

8.30 am – 9.30 am: Keys to Cleaning

Validation Maintenance – Remaining Compliant

Change Control:

Changes in Cleaning/Sanitization Agents, Cleaning Procedures, Manufacturing Equipment or Procedures and changes in Product Formulas

9.30 am – 11.00 am: Keys to Cleaning Validation Maintenance – Remaining Compliant

Proper evaluation and approval pre and post change implementation

Documented evaluation and follow up.

11.00 am – 11.15 am: Break

11.15 am – 12.00 pm: Keys to Cleaning Validation Maintenance – Remaining

Monitoring after equipment cleaning – Visual Inspection and Frequent Sampling/Testing

Monitoring after area cleaning/sanitization procedures

12.00 pm – 1.00 pm: Lunch

1.00 pm – 2.00 pm: Issues for Specific Sub-Industries and Related Manufacturing Facilities

Active Pharmaceutical Ingredient (API) Manufacturers

Biotechnology Facilities

Dietary Supplement Manufacturers

2.00 pm – 2.45 pm: Current FDA concerns about validation of cleaning processes

Cleaning validation deficiencies observed by the regulatory inspectors, as reported in Establishment Inspection Reports (EIRs), FDA 483 observations and Warning Letters

2.45 pm – 3.00 pm: Break

3.00 pm – 4.15 pm: The future of cleaning processes and cleaning validation

Containment Concept, EMEA, and ISPE Use of Disposable Equipment

New innovative equipment design facilitating easier cleaning

New cleaning technology (e.g. sprayball design)

4.15 pm – 4.30 pm: Questions/Answers/Comments

Seminar Summary:

This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. (see full course description)

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