The Quality assurance manual for the pharmaceutical and medical device industries part 2



Validation for medical device and diagnostic manufacturers

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004770230 / 1998-03-05
Date of Publication:
November 1, 1997
Date of Creation:
1997
Title:
Validation for medical device and diagnostic manufacturers / Carol V. DeSain & Charmaine V. Sutton.
Edition:
2nd ed.
Basis of Claim:
New Matter: revisions & additions.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1998.
Description:
314 p.
Copyright Claimant:
Interpharm Press, Inc.
Names:
Carol V. DeSain 1949-
Charmaine Vercimak Sutton 1959-
Interpharm Press, Inc.

Copyrights records by Interpharm Press, Inc.

The QC laboratory chemist

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004791281 / 1998-06-03
Date of Publication:
May 29, 1998
Date of Creation:
1998
Title:
The QC laboratory chemist : plain and simple / Clifford L. Nilsen.
Description:
275 p. + 1998 catalog suppl.
Variant title:
The QC laboratory chemist : plain and simple
Copyright Claimant:
Interpharm Press, Inc.
Names:
Clifford L. Nilsen
Interpharm Press, Inc. (79 documents)
example document: Metered dose inhaler technology

The survive and thrive guide to computer validation

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004808561 / 1998-06-17
Date of Publication:
June 11, 1998
Date of Creation:
1998
Title:
The survive and thrive guide to computer validation / Teri Stokes.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1998.
Description:
307 p.
Copyright Claimant:
Interpharm Press, Inc.
Names:
Teri Stokes 1943-
Interpharm Press, Inc.

GMP/ISO/En quality audit manual for healthcare manufacturers and their suppliers

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004845630 / 1998-08-20
Date of Publication:
August 3, 1998
Date of Creation:
1998
Title:
GMP/ISO/En quality audit manual for healthcare manufacturers and their suppliers / Leonard Steinborn.
Edition:
5th ed.
Description:
Software package.
Copyright Claimant:
Interpharm Press, Inc.
Names:
Leonard Steinborn 1946-
Interpharm Press, Inc.

Pharmaceutical water

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004864583 / 1998-10-05
Date of Publication:
September 28, 1998
Date of Creation:
1998
Title:
Pharmaceutical water : system design, operation, and validation / William V. Collentro.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1999.
Description:
682 p.
Variant title:
Pharmaceutical water : system design, operation, and validation
Copyright Claimant:
Interpharm Press, Inc.
Names:
William V. Collentro 1944-
Interpharm Press, Inc.

Pharmaceutical unit operations

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004866455 / 1998-10-05
Date of Publication:
September 12, 1998
Date of Creation:
1998
Title:
Pharmaceutical unit operations : coating / Kenneth E. Avis, Atul J. Shukla, Rong-Kun Chang, editors.
Series:
Drug manufacturing technology series ; vol. 3
Imprint:
Buffalo Grove, IL : Interpharm Press, c1999.
Description:
348 p.
Variant title:
Pharmaceutical unit operations : coating
Other Title:
Drug manufacturing technology series ; vol. 3
Copyright Claimant:
Interpharm Press, Inc.
Names:
Atul J. Shukla
Rong-Kun Chang
Kenneth E. Avis 1918-
Interpharm Press, Inc.

Validation and qualification in analytical laboratories

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004886603 / 1998-11-09
Date of Publication:
October 20, 1998
Date of Creation:
1998
Title:
Validation and qualification in analytical laboratories / Ludwig Huber.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1999.
Description:
318 p.
Copyright Claimant:
Interpharm Press, Inc.
Names:
Ludwig Huber 1948-
Interpharm Press, Inc.

Good technical management practices

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004889735 / 1998-11-09
Date of Publication:
October 12, 1998
Date of Creation:
1998
Title:
Good technical management practices : a complete menu / James Edward Tingstad.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1999.
Description:
344 p.
Copyright Claimant:
Interpharm Press, Inc.
Names:
James Edward Tingstad 1917-
Interpharm Press, Inc.

International medical device clinical investigations

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005285821 / 2000-10-16
Date of Publication:
April 19, 1999
Date of Creation:
1999
Title:
International medical device clinical investigations : a practical approach / edited by Herman Pieterse, Marja G. deJong, Peter Duijst.
Edition:
2nd ed.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1999.
Description:
567 p.
Copyright Claimant:
Interpharm Press, Inc.
Names:
Herman Pieterse
Marja G. deJong
Peter Duijst
Interpharm Press, Inc.

Water-insoluble drug formulation

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005285891 / 2000-10-16
Date of Publication:
September 15, 2000
Date of Creation:
2000
Title:
Water-insoluble drug formulation / Rong Liu, editor.
Imprint:
Denver : Interpharm Press, c2000.
Description:
651 p.
Copyright Claimant:
Interpharm Press, Inc.
Authorship on Application:
editor: Guy Wingate, 1956-
Names:
Rong Liu
Guy Wingate 1956-
Interpharm Press, Inc.

Validating corporate computer systems

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005285907 / 2000-10-16
Date of Publication:
May 31, 2000
Date of Creation:
2000
Title:
Validating corporate computer systems : good IT practice for pharmaceutical manufacturers / editor, Guy Wingate.
Imprint:
Englewood, CO : Interpharm Press, c2000.
Description:
526 p.
Copyright Claimant:
Interpharm Press, Inc.
Names:
Guy Wingate 1965-
Interpharm Press, Inc. (79 documents)
example document: GLP essentials

How to sell validatable equipment to pharmaceutical manufacturers

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005286141 / 2000-10-16
Date of Publication:
September 30, 1999
Date of Creation:
1999
Title:
How to sell validatable equipment to pharmaceutical manufacturers / Erik Kopp.
Imprint:
Denver : Interpharm Press, c2000.
Description:
349 p.
Copyright Claimant:
Interpharm Press, Inc.
Names:
Erik Kopp
Interpharm Press, Inc.

Practical guide to clinical data management

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005287950 / 2000-10-16
Date of Publication:
April 19, 1999
Date of Creation:
1999
Title:
Practical guide to clinical data management / Susanne Prokscha.
Imprint:
Denver : Interpharm Press, c1999.
Description:
274 p.
Copyright Claimant:
Interpharm Press, Inc.
Names:
Susanne Prokscha
Interpharm Press, Inc. (79 documents)
example document: FDA regulation of medical devices

International clinical trials

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005288451 / 2000-10-13
Date of Publication:
June 18, 1999
Date of Creation:
1999
Title:
International clinical trials : a guidebook and compendium of national drug laws : vol. 1-2 / edited by Dominique P. Brunier and Gerhard Nahler.
Imprint:
Denver : Interpharm Press, c1999.
Variant title:
International clinical trials : a guidebook and compendium of national drug laws : vol. 1-2
Copyright Claimant:
Interpharm Press, Inc.
Names:
Dominique P. Brunier
Gerhard Nahler
Interpharm Press, Inc. (79 documents)
example document: Good manufacturing practice

How to develop and manage qualification protocols for FDA compliance

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005296321 / 2000-10-13
Date of Publication:
August 12, 1999
Date of Creation:
1999
Title:
How to develop and manage qualification protocols for FDA compliance / Phil Cloud.
Imprint:
Denver : Interpharm Press, c1999.
Description:
375 p.
Copyright Claimant:
Interpharm Press, Inc.
Names:
Phil Cloud 1938-
Interpharm Press, Inc. (79 documents)
example document: Sterilization of drugs and devices

Pharmaceutical manufacturing change control

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005296485 / 2000-10-13
Date of Publication:
March 26, 1999
Date of Creation:
1999
Title:
Pharmaceutical manufacturing change control / edited by Simon G. Turner.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1999.
Description:
180 p.
Copyright Claimant:
Interpharm Press, Inc.
Names:
Simon G. Turner
Interpharm Press, Inc.

Drug development programme management

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005299948 / 2000-11-13
Date of Publication:
October 9, 2000
Date of Creation:
2000
Title:
Drug development programme management / Barbara Ann Lead.
Imprint:
Denver : Interpharm Press, c2001.
Description:
223 p.
Copyright Claimant:
Interpharm Press, Inc.
Names:
Barbara Ann Lead 1951-
Interpharm Press, Inc.

GLP applications for test substance control, formulation, and analysis

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005454065 / 2001-10-10
Date of Publication:
November 15, 1997
Date of Creation:
1997
Title:
GLP applications for test substance control, formulation, and analysis / Richard Halliday, Bud Carthy, Albert Cowell, Lisa Gascoigne.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1997.
Description:
39 p.
Copyright Claimant:
Interpharm Press, Inc., now k.a. IHS Health Group
Names:
Bud Carthy
Albert Cowell
Lisa Gascoigne
Richard Halliday 1943-
Interpharm Press, Inc.
IHS Health Group

Copyrights records by IHS Health Group

Practical guide to GMPs for device and diagnostic manufacturers

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005454071 / 2001-10-10
Date of Publication:
January 15, 1997
Date of Creation:
1997
Title:
Practical guide to GMPs for device and diagnostic manufacturers : 21 CFR 820, effective June 1997, EN 46001, ISO 9001 / Steven S. Kuwahara.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1997.
Description:
192 p.
Variant title:
Practical guide to GMPs for device and diagnostic manufacturers : 21 CFR 820, effective June 1997, EN 46001, ISO 9001
Copyright Claimant:
Interpharm Press, Inc., n.k.a. IHS Health Group
Names:
Steven S. Kuwahara 1940-
Interpharm Press, Inc.
IHS Health Group (8 documents)
example document: European markets for arrhythmia management products

How to develop and manage qualification protocols for FDA compliance

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005454082 / 2001-10-10
Date of Publication:
January 15, 1998
Date of Creation:
1998
Title:
How to develop and manage qualification protocols for FDA compliance / Phil Cloud.
Imprint:
Denver : Interpharm Press, c1999.
Description:
375 p.
Copyright Claimant:
Interpharm Press, Inc. n.k.a. IHS Health Group
Names:
Phil Cloud 1938-
Interpharm Press, Inc.
IHS Health Group (8 documents)
example document: European markets for arrhythmia management products

The Quality assurance manual for the pharmaceutical and medical device industries

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TXu000165507 / 1984-07-10
Date of Creation:
1983
Title:
The Quality assurance manual for the pharmaceutical and medical device industries / Leonard Steinborn.
Edition:
1st ed.
Description:
1 v.
Copyright Claimant:
Interpharm Press, Inc.
Names:
Leonard Steinborn
Interpharm Press, Inc.

Data acquisition and measurement techniques

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TXu000864995 / 1998-07-24
Date of Creation:
1998
Title:
Data acquisition and measurement techniques.
Description:
393 p.
Copyright Claimant:
Interpharm Press, Inc.
Authorship on Application:
Angel Munoz-Ruiz, 1964-, Herman Vromans, 1958-
Names:
Angel Munoz-Ruiz 1964-
Herman Vromans 1958-
Angel Munoz Ruiz
Interpharm Press, Inc.

Electronic communication technologies

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TXu000869330 / 1998-08-12
Date of Creation:
1998
Title:
Electronic communication technologies : techniques and technologies for the 21st century : a practical guide for healthcare manufacturers / edited by Mervyn Mitchard, 1935-.
Description:
596 p.
Variant title:
Electronic communication technologies : techniques and technologies for the 21st century
Copyright Claimant:
Interpharm Press, Inc.
Names:
Mervyn Mitchard 1935-
Interpharm Press, Inc.
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