Gmp seminar schedules-2013

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
3
 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
http:www.cgmpuniversity.com

WHO WILL BENEFIT
4

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


5

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

6 Date and location
Location and date:
WHERE? WHEN?

1.Sheraton Hotel, San Francisco November 26th-27th 2012
International Airport,CA
2.Doublee Tree Hotel, March 25th-26th 2013
Philladelphia,PA


7

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
9
 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.

10 WHO WILL BENEFIT
The class is designed for the following personnel:
 Quality Engineers

 Supplier Quality Engineers

 Supply chain personnel

 Quality managers

 Product development Engineers


11

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.

12

TARGET INDUSTRIES
The class is designed for professional in the following
industries:

 Medical device
 Pharmaceutical industries
 Biologics
 Cellular therapy
 Dietary supplements


13 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


14

on seminar is $1795

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
16
 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
17

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

18

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

19

INDUSTRIES TARGET
The class is designed for professionals in the
following industries:

 Pharmaceutical manufacturing
 Medical device
 Cellular therapy
 Blood banking
 Dietary supplements


20 Date and location
Location and date:
WHERE? WHEN?

1.Sheraton Hotel, San Francisco July 22 nd-23rd 2013
International Airport.
2. Double Tree, September 23rd-24th 2013
Philladelphia,PA


21

on seminar is $1975

seminar tab on our website at
:http//www.cgmpuniversity.com


22

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


23

AVASA HOTEL HYDERABAD INDIA

24

NEW DELHI HILTON INDIA

Gmp seminar schedules-2013

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