gmp seminar schedules-2013

INSTRUCTOR LEAD SEMINARS.

COURSE #0001: PRINCIPLES OF QUALITY BY DESIGN(QbD) FOR GENERIC DRUG MANUFACTURERS

Quality should be designed into the product and process that manufactures the product

INTRODUCTION

http:\\www.cgmpuniversity.com

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Starting in January 2013, the U.S. Food and Drug

Administration (FDA) expect generic drug

manufacturers to implement Quality by Design

(QbD) into their Abbreviated New Drug

Applications (ANDA).

Soon all Pharmaceutical manufacturers will be

required to implement QbD. Unfortunately,

professionals in most companies struggle with the

QbD concept.

This seminar teaches attendees how to apply QbD

principles in product design and manufacturing

WHO WILL BENEFIT


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The class is designed for the following personnel:

Quality Engineers

Manufacturing Engineers

Process Engineers

Regulatory personnel

Product development Engineers

Managers of companies that

manufacture generic drugs

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WHAT YOU WILL LEARN:

Attendees will learn the following:

The FDA’s current thinking about pharmaceutical product design and approval

Integration of ICHQ6, ICHQ8,ICHQ9,and ICHQ10 into QbD

ICHQ11 requirements for QbD

The risk based pharmaceutical and microbiologic product and process design

Use of scientifically based, and statistically sound decisions in product and process development

Use of scientific and statistical tools to design products and processes

Methods for risk assessment

The concept of design space


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Location and date:

Date and location


WHERE? WHEN?

1.Sheraton Hotel, San Francisco

International Airport,CA

November 26th-27th 2012

2.Doublee Tree Hotel,

Philladelphia,PA

March 25th-26th 2013

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The Cost for this two day hands on seminar is $1575

Space is limited: Register on the seminar tab on our website at :

http//www.cgmpuniversity.com


COURSE #0002 : PRINCIPLES OF SUPPLIER QUALITY MANAGEMENT

Supplier Quality management involves supplier evaluation, supplier selection, supplier Qualification ,supplier management and supplier relations.

INTRODUCTION


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Supplier Quality Management poses a serious

threat to Quality management in FDA regulated

industries because most processes in

manufacturing are outsourced

This class teaches attendees principles governing

Supplier Quality Management including material

Qualification, supplier Qualification, and supplier

management

The class also covers supplier Quality

Agreements, Supplier corrective Action, supplier

Audits and the ASL.

The class is designed for the following personnel:

Quality Engineers

Supplier Quality Engineers

Supply chain personnel

Quality managers

Product development Engineers

WHO WILL BENEFIT 10


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WHAT YOU WILL LEARN


Supplier Qualification process

Supplier Quality management life cycle

Roles and responsibilities of Quality and supply chain in supplier Quality management

Elements of the supplier Quality agreement

How to perform a supplier audit

Supplier performance matrix and the ASL

Relationship between the SCAR system and CAPA.


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TARGET INDUSTRIES

The class is designed for professional in the following industries:

Medical device

Pharmaceutical industries

Biologics

Cellular therapy

Dietary supplements


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Location and date:

Date and location


WHERE? WHEN?


Airport, California

April 08th-09th 2013

2.Double Tree,Philadelphia May 20th-21st 2013

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Space is limited: Register on the seminar tab on our website at :http//www.cgmpuniversity.com


Change control is a risk management tool that protects the organization against waste, variation in product and processes, regulatory exposure and product liability

INTRODUCTION


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Change control is a very complicated process.

Failure to control the effects of a proposed change

can lead to product liability, product recalls and

waste

The class is design to approaches change control

from a system and product life cycle from design

to retirement

The key principles of risk assessment and impact

assessment are covered in detail

Tools for impact assessment and risk assessment

are taught

WHO WILL BENEFIT


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1.Change control managers

2.Regulatory affairs personnel

3.Product design personnel

4.Purchasing/supply chain personnel

5.Change control administrators

6.Quality Engineers

7.Manufacturing Engineers

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WHAT YOU WILL LEARN


The change control life cycle

Change classification: minor, moderate, and major

Regulatory requirements change control

How to perform impact assessment

How to perform Quality risk Management(QRM)

How to perform risk assessment

Risk assessment tools


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INDUSTRIES TARGET

The class is designed for professionals in the following industries:

Pharmaceutical manufacturing

Medical device

Cellular therapy

Blood banking

Dietary supplements


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Location and date:

Date and location


WHERE? WHEN?


International Airport.

July 22 nd-23rd 2013

2. Double Tree,

Philladelphia,PA

September 23rd-24th 2013

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Space is limited: Register on the seminar tab on our website at :http//www.cgmpuniversity.com


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For more information about registration FOR OUR WORLD RENOWNED seminars and webinars contact us:

1. Email: [email protected] 2.Toll: 1800-396-3991 3.Office: (408)-459-GMP


mailto:[email protected]

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AVASA HOTEL HYDERABAD INDIA

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NEW DELHI HILTON INDIA

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SAN FRANCISCO,USA

gmp seminar schedules-2013

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