Seminar on Requirements for Establishing an Effective Cleaning Validation Program training seminars presented by Global Compliance Panel register now on FindaSeminar.com

findaseminar logo balls FindaSeminar.com
event search registration and marketing services since 2002
Advanced Search
 
 

** NOTE: All April seminars are live Virtual or Online click to view events.

Seminar on Requirements for Establishing an Effective Cleaning Validation Program  

 Email information about this seminar Seminar on Requirements for Establishing an Effective Cleaning Validation Program by Global Compliance Panel to yourself your manager or associates Email this event... View and register for other training seminars like Seminar on Requirements for Establishing an Effective Cleaning Validation Program by Global Compliance Panel on FindaSeminar.com Find similar training.. Find and register for other training seminars by Global Compliance Panel on FindaSeminar.com Other seminars from Global Compliance Panel

By:

Global Compliance Panel   

For:

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

Cost:   

see Registration info for seminar cost, group discount etc.

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)

 

 Seminar / Training class dates & locations

 

No seminar dates for this event are currently scheduled.  Please use the seminars search box above or choose one of the following additional training search options to find similar training.

Cleaning+Validation+Master+Plans+procedures+approach+programs training seminars workshops conferences online training

Providers course catalog

Find seminars by state

Find seminars by city

Request on site training

Use Advanced Search

NEW  Don't miss training you want to attend

Receive a personal Training Alert when training you want to attend comes to your area. Create a personal Training Alert now  it's Free and only takes a minute!


 

 

 

share this page 

print the agenda print agenda for the Seminar on Requirements for Establishing an Effective Cleaning Validation Program seminar

 

 

Training Course Syllabus:


Requirements for Establishing an Effective Cleaning Validation Program

Course "Requirements for Establishing an Effective Cleaning Validation Program" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant´s RAC recertification upon full completion.

Overview:

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.

Why should you attend?

Attendance at 2 day seminar will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.

Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful.

Areas Covered in the Session:

• 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


Agenda:

Day 1 Schedule:

Lecture 1:
• FDA Requirements and Industry Standard Practices
Lecture 2:
• How to Develop/Review your Cleaning Procedures and the Adequate Selection of Cleaning Agents and Parameters
Lecture 3:
• How to Develop a Cleaning Validation Policy/Program
Lecture 4:
• How to Implement a Robust Cleaning Validation Plan

Day 2 Schedule:


Lecture 1:
• Laboratory Issues in Cleaning
Lecture 2:
• Microbiological aspects of a cleaning validation program for manufacturing equipment
Lecture 3:
• Keys to Cleaning Validation Maintenance - Remaining Compliant
Lecture 4:
• Current FDA concerns about validation of cleaning processes

Speaker:

Joy McElroy

Principle Consultant at Maynard Consulting Company
Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.
Now with 12 years’ experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.
Joy specializes in Equipment Qualification, Cleaning Validation, Sterilization, Environmental Monitoring, and GMP Compliance Auditing.

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)

print this agenda print agenda for the Seminar on Requirements for Establishing an Effective Cleaning Validation Program training seminar

 view dates and locations for this seminar

 

 

 

Custom Search