CGMP University - GMP Training and Proactive Quality Management - Compliance Resolution

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
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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
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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
WHAT YOU WILL LEARN: Attendees will learn the following: The FDAs 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
Date and location

Location and date:
WHERE? WHEN? 1.Sheraton Hotel, San Francisco November 26th-27th 2012 International Airport,CA 2.Doublee Tree Hotel, Philladelphia,PA March 25th-26th 2013
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.
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WHO WILL BENEFIT

The class is designed for the following personnel: Quality Engineers Supplier Quality Engineers Supply chain personnel Quality managers Product development Engineers
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WHAT YOU WILL LEARN Attendees will learn the following:
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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Date and location

Location and date:
WHERE? WHEN? 1.Sheraton Hotel, San Francisco April 08th-09th 2013 Airport, California 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 Attendees will learn the following:
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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Date and location

Location and date:
WHERE? WHEN? 1.Sheraton Hotel, San Francisco July 22 nd-23rd 2013 International Airport. 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: Support@cgmpuniversity.com 2.Toll: 1800-396-3991 3.Office: (408)-459-GMP
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AVASA HOTEL HYDERABAD INDIA
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NEW DELHI HILTON INDIA
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SAN FRANCISCO,USA

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INSTRUCTOR LEAD SEMINARS.

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

WHO WILL BENEFIT

Use of scientific and statistical tools to design products and processes

Date and location

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

WHO WILL BENEFIT

WHAT YOU WILL LEARN Attendees will learn the following:

Medical device Pharmaceutical industries Biologics Cellular therapy Dietary supplements

Date and location

The Cost for this two day hands on seminar is $1795

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

WHO WILL BENEFIT

1.Change control managers

WHAT YOU WILL LEARN Attendees will learn the following:

The class is designed for professionals in the following industries:

Date and location

The Cost for this two day hands on seminar is $1975

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

1. Email: Support@cgmpuniversity.com 2.Toll: 1800-396-3991 3.Office: (408)-459-GMP

AVASA HOTEL HYDERABAD INDIA

NEW DELHI HILTON INDIA

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