Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach

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Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach

Price List:

For 1 Delegate pass Price:

$ 1,295.00

Register now and save (Early Bird)

$200. Price

Register Now

**Please note the registr ation will be

closed 2 days (48 Hours) prior to the

date of the seminar.

Jonathan M. Lewis

9:00 AM to 6:00 PM

St. Petersburg, FL

December 3rd & 4th, 2015

Course "Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach"

has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full

completion.

Jonathan M. Lewis

Principal, Advanced Biomedical Consulting (ABC), LLC

Jonathan M. Lewis Founding Partner, Reliant FDA Experts®...a Division of Advanced Biomedical Consulting, LLC,

has over twenty-three years' experience in the areas of quality control/quality assurance (QA/QC), regulatory

affairs, manufacturing, validation, project management, and executive management in both industry and

consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical,

cosmetic, nutritional supplement, food, and animal food industries.Prior to founding Reliant FDA Experts®, Mr.

Lewis worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of

responsibility from an entry-level Validation Engineer to an Associate Director of Consulting.

Overview:

Companies face many common issues and confusion when creating or revamping their validation programs.

Some of these common issues are:

Company has expertise in its process validation program but can never quite get is arms around the facility and equipment changes

that require never ending equipment qualification (IQ, OQ, PQ),

Customer or 483 audit findings require the company to deviate from its own validation program to meet the needs of the FDA or the

customer

For systems that employ software and hardware, how does the company manage the validation activities (i.e. through the software

validation effort or through the equipment qualification program?

Well, the answers to these and many, many more typical questions are now available in this simple to understand, yet detailed

training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.

www.globalcompliancepanel.com

https://www.globalcompliancepanel.com/control/globalseminars/~product_id=900295SEMINAR?equipment-facility-process-qualification-validation






Day 1 Schedule Continue...


Agenda:

Understanding the Basics Of Validation

Regulatory References

Validation Terminology

The Components of a Sustainable Validation Program

Design Qualification

FATs and SATs

Commissioning

The Validation Master Plan

The Validation Project Plan

Standard Operating Procedures (SOPs)

Protocols

Reports

Additional Software Validation Documents

Other Programs that Feed the Validation Program

Change Control

Complaint Handling

CAPAs

Deviation Management

Maintenance

Sales

Equipment, Utility, and Facility Qualification

The SOP

Protocol Template

Minimal Testing and Verifications for IOQ

Minimal Testing and Verifications for PQ

Facility Qualification

Execution of Protocols

Report Generation

Process Validation

The SOP

Protocol Template

Minimal Testing and Verifications for IOQ


Report Generation

Software Validation

The SOP

Protocol Template

Additional Software Validation Document Templates

Minimal Testing and Verifications


Report Generation

Time and Costs Associated with Validation

Estimating Time Associated with Each "Deliverable”

Hidden Costs of Validation

Estimating Costs of Using Validation Consultants

How to Recoup Costs Associated with Validation for

Contract Manufacturers

Responding to Audit Findings Associated with

Validation

Day 2 Schedule

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Welcome and Day 1 Reinforcement

Practical Application # 1 -Equipment Qualification

Practical Application # 2 -483 Response

Closing Comments

Individual/Open Q&A Session

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Contact Information: Event Coordinator

NetZealous LLC, DBA TrainHR

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

Toll free: +1-800-447-9407

Fax: 302 288 6884

Email: [email protected]

Kindly get in touch with us for any help or information.

Look forward to meeting you at the seminar

GlobalCompliancePanel



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Group Participation What You will get

Special price on future seminars by

GlobalCompliancePanel.

Networking with industry's top notch professionals

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1 Learning Objectives

2 Participation certificates

Interactive sessions with the US expert

Post event email assistance to your queries.

Special price on future purchase of web

based trainings.

Special price on future consulting or expertise

services.

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Seminar Kit – includes presentation handout,

ID card, brochure, trainings catalog, notepad

and pen.

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Payment Option

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mailed to 161 Mission Falls Lane, Suite 216,

Fremont, CA 94539, USA

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