Skip to content

Booksellers & Trade Customers: Sign up for online bulk buying at trade.atlanticbooks.com for wholesale discounts

Booksellers: Create Account on our B2B Portal for wholesale discounts

Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents, Concise Reference, Second Edit by Kirstin a. Counts

Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents, Concise Reference, Second Edit

by Kirstin a. Counts
Save 9% Save 9%
₹4,717.00
₹5,194.00
₹5,194.00
₹5,194.00
(-9%)
₹4,717.00
₹4,717.00

Imported Edition - Ships in 18-21 Days

Free Shipping in India on orders above Rs. 500

Request Bulk Quantity Quote
+91
Book cover type: Paperback
  • ISBN13: 9781937258177
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Pharmalogika Books
  • Publisher Imprint: Pharmalogika Books
  • Publication Date:
  • Pages: 688
  • Original Price: USD 52.99
  • Language: English
  • Edition: N/A
  • Item Weight: 903 grams
  • BISAC Subject(s): General

FDA Regulations and Associated Guidance Documents: - Code of Federal Regulation Title 21 Overview - Part 11 Electronic Records; Electronic Signatures (21CFR 11) and Guidance for Industry - Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community (21CFR 26) - Part 200 Drugs: General (21CFR 200) - Part 207 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and The National Drug Code (21CFR 207) - Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General (21CFR 210) - Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals (21CFR 211) - Part 600 Biological Products: General (21CFR 600) - Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices (21CFR 807) - Part 820 Quality System Regulation (21CFR 820) - Part 11, Electronic Records; Electronic Signatures - Scope and Application - Guidance for Industry and FD A Staff: Current Good Manufacturing Practice Requirements for Combination Products - Guidance for Industry: CGMP for Phase 1 Investigational Drugs - Process Validation: General Principles and Practices - PAT - A Frame work for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance - Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations - Contract Manufacturing Arrangements for Drugs: Quality Agreements - Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP - Formal Dispute Resolution: Sponsor Appeals Above the Division Level Reference Tools: - Glossaries combined in one location - GMP Keyword Index for 21CFR211 - Combined Index for all documents

Mindy Allport-Settle has served as a key executive, board member, and consultant for some of the best companies in the pharmaceutical and FDA-regulated industry. Since joining PharmaLogika as CEO in 2008 and over her career, she has provided informed guidance in regulatory compliance, corporate structuring, restructuring and turnarounds, new drug submissions, research & development and product commercialization strategies, operational, project and contract management, and new business development. Her experience and dedication have resulted in international recognition as the developer of the only FDA-recognized and benchmarked quality systems training and development business methodology designed for regulated industries. Her education includes a Bachelor's degree from the University of North Carolina, an MBA in Global Management from the University of Phoenix, and completion of the corporate governance course series in audit committees, compensation committees, and board effectiveness at Harvard Business School.

Trusted for over 49 years

Family Owned Company

Secure Payment

All Major Credit Cards/Debit Cards/UPI & More Accepted

New & Authentic Products

India's Largest Distributor

Need Support?

Whatsapp Us

Related Category

reference > general

Bestselling

View All
Atomic Habits (Lead Title) by Clear, James

Atomic Habits (Lead Title)

Clear, James

₹585
₹899
₹899
₹899
(-35%)
₹585
₹585

• Author(s): Clear | James • Publisher: Penguin • Publisher Imprint: Penguin Random House • Subject: General Books

Diary of a Wimpy Kid: Partypooper (Book 20) by Jeff Kinney

Diary of a Wimpy Kid: Partypooper (Book 20)

Jeff Kinney

₹455
₹699
₹699
₹699
(-35%)
₹455
₹455

• Author(s): Jeff Kinney • Publisher: Penguin Random House Children's UK • Publisher Imprint: Penguin Random House Children's UK • BISAC: Comics & Graphic Novels - Humorous

Ikigai by Hector Garcia

Ikigai

Hector Garcia

₹390
₹599
₹599
₹599
(-35%)
₹390
₹390

• Author(s): Hector Garcia • Publisher: Penguin • Publisher Imprint: Penguin Random House • Subject: General Books

The Courage To Be Disliked How To Free Yourself Change Your Life And Achieve Real Happiness Courage To Series by Ichiro Kishimi

The Courage To Be Disliked How To Free Yourself Change Your Life And Achieve Real Happiness Courage To Series

Ichiro Kishimi

₹358
₹550
₹550
₹550
(-35%)
₹358
₹358

• Author(s): Ichiro Kishimi • Publisher: GROVE ATLANTIC • Publisher Imprint: Allen & Unwin • BISAC: Personal Growth - SuccessIchiro Kishimi lives in Kyoto. He writes, lectures and teaches in psychiatric clinics as a certified counsellor and c...

View full details
12 Years: My Messed-up Love Story by Chetan Bhagat

12 Years: My Messed-up Love Story

Chetan Bhagat

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Chetan Bhagat • Publisher: HarperCollins Publishers India • Publisher Imprint: HarperCollins Publishers India • BISAC: GeneralFrom India's top-selling writer Chetan Bhagat comes a powerful new love story that will make you laugh, cry...

View full details
The Mountain Is You: Transforming Self-Sabotage Into Self-Mastery

The Mountain Is You: Transforming Self-Sabotage Into Self-Mastery

Brianna Wiest

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Brianna Wiest • Publisher: Manjul Publishing • Publisher Imprint: Amaryllis • BISAC: Body Mind And SpiritThis is a book about self-sabotage. Why we do it, when we do it, and how to stop doing it—for good. Coexisting but conflicting n...

View full details
The Art of Spending Money: Simple Choices for a Richer Life by Morgan Housel

The Art of Spending Money: Simple Choices for a Richer Life

Morgan Housel

₹290
₹499
₹499
₹499
(-42%)
₹290
₹290

• Author(s): Morgan Housel • Publisher: Pan Macmillan • Publisher Imprint: Pan Macmillan • BISAC: Finance - Wealth ManagementA third book from the International bestselling author of The Psychology of Money and Same as Ever, lessons on harnessing...

View full details
Mother Mary Comes To Me by Arundhati Roy

Mother Mary Comes To Me

Arundhati Roy

₹585
₹899
₹899
₹899
(-35%)
₹585
₹585

• Author(s): Arundhati Roy• Publisher: PRH INDIA LOCAL PRINT• Publisher Imprint: Penguin Hamish Hamilton• BISAC: Literary FiguresArundhati Roy’s first work of memoir, this is a soaring account, both intimate and inspiring, of how the author became...

View full details
Truth without Apology: A Guide for Those Who Can Stand It by Acharya Prashant

Truth without Apology: A Guide for Those Who Can Stand It

Acharya Prashant

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Acharya Prashant • Publisher: HarperCollins Publishers India • Publisher Imprint: HarperCollins Publishers India • BISAC: GeneralIn a world where vagueness is mistaken for depth and obscurity passes for wisdom, Truth without Apology ...

View full details
Grandma's Bag of Stories by Sudha Murthy

Grandma's Bag of Stories

Sudha Murthy

₹179
₹275
₹275
₹275
(-35%)
₹179
₹179

• Author(s): Sudha Murthy • Publisher: India Puffin • Publisher Imprint: India Puffin • BISAC: Short StoriesWho can resist a good story, especially when it's being told by Grandma? From her bag emerges tales of kings and cheats, monkeys and mic...

View full details
Days at the Morisaki Bookshop by Satoshi Yagisawa

Days at the Morisaki Bookshop

Satoshi Yagisawa

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Satoshi Yagisawa • Publisher: Bonnier Books Ltd • Publisher Imprint: Bonnier Books Ltd

Deep Work: Rules For Focused Success In A Distracted World by Newport, Cal

Deep Work: Rules For Focused Success In A Distracted World

Newport, Cal

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Newport, Cal • Publisher: Little, Brown Book Group • Publisher Imprint: Piatkus

Can We Be Strangers Again?: A National Bestseller by Shrijeet Shandilya

Can We Be Strangers Again?: A National Bestseller

Shrijeet Shandilya

₹195
₹299
₹299
₹299
(-35%)
₹195
₹195

• Author(s): Shrijeet Shandilya • Publisher: Ebury Press • Publisher Imprint: Ebury Press • BISAC: Romance - GeneralIn the electric haze of college life, three friends are bound by laughter, late-night talks and unspoken promises. But when two of...

View full details
The Secret of Secrets: (Robert Langdon Book 6) by Dan Brown

The Secret of Secrets: (Robert Langdon Book 6)

Dan Brown

₹975
₹1,499
₹1,499
₹1,499
(-35%)
₹975
₹975

• Author(s): Dan Brown • Publisher: Transworld Publishers Ltd • Publisher Imprint: Transworld Publishers Ltd • BISAC: Thrillers - EspionageDan Brown is the bestselling author of Digital Fortress, Deception Point, Angels and Demons, The Da Vinci C...

View full details
Magic of the Lost Temple by Sudha Murty

Magic of the Lost Temple

Sudha Murty

₹179
₹275
₹275
₹275
(-35%)
₹179
₹179

• Author(s): Sudha Murty • Publisher: India Puffin • Publisher Imprint: India Puffin • BISAC: Action & Adventure - General

Rich Dad Poor Dad: What the Rich Teach Their Kids about Money That the Poor and Middle Class Do Not!

Rich Dad Poor Dad: What the Rich Teach Their Kids about Money That the Poor and Middle Class Do Not!

₹390
₹599
₹599
₹599
(-35%)
₹390
₹390

• Publisher: Penguin • Publisher Imprint: Penguin Random House • Subject: General Books • BISAC: Personal Finance - GeneralApril of 2022 marks a 25-year milestone for the personal finance classic Rich Dad Poor Dad that still ranks as the #1 Pers...

View full details
World’S Greatest Books For Personal Growth & Wealth (Set Of 4 Books) : Perfect Motivational by Dale Carnegie, Napoleon Hill

World’S Greatest Books For Personal Growth & Wealth (Set Of 4 Books) : Perfect Motivational

Dale Carnegie, Napoleon Hill

₹390
₹599
₹599
₹599
(-35%)
₹390
₹390

• Author(s): Dale Carnegie | Napoleon Hill • Publisher: Fingerprint • Publisher Imprint: Fingerprint • Subject: General Books

The Housemaid: An Addictive Psychological Thriller With Mind-Bending Twists by Freida Mcfadden

The Housemaid: An Addictive Psychological Thriller With Mind-Bending Twists

Freida Mcfadden

₹358
₹550
₹550
₹550
(-35%)
₹358
₹358

• Author(s): Freida Mcfadden • Publisher: Penguin Select Print • Publisher Imprint: Penguin Select Publishing"Multi-Million Copy Bestselling Series •Now Being Made Into a Major Motion Picture Starring Sydney Sweeney and Amanda Seyfried #1 New Yor...

View full details
101 Tales: The Great Panchatantra Collection by Wonder House Books

101 Tales: The Great Panchatantra Collection

Wonder House Books

₹390
₹599
₹599
₹599
(-35%)
₹390
₹390

• Author(s): Wonder House Books • Publisher: Wonder House Books • Publisher Imprint: Wonder House Books • BISAC: Comics & Graphic Novels - Fairy Tales, Folklore, Legends & MTimeless Wisdom, Talking Animals & Life Lessons for Young Min...

View full details
Man's Search For Meaning by Viktor E. Frankl

Man's Search For Meaning

Viktor E. Frankl

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Viktor E. Frankl • Publisher: Random House • Publisher Imprint: Random Hou • Subject: Medical, Nursing and Health Sciences

Bacchon KI Doctor's Desi Parenting Book: A Doctor-Mom's Guide to Milk, Myths, Motherhood and More by Madhavi Bharadwaj

Bacchon KI Doctor's Desi Parenting Book: A Doctor-Mom's Guide to Milk, Myths, Motherhood and More

Madhavi Bharadwaj

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Madhavi Bharadwaj • Publisher: PRH India • Publisher Imprint: Penguin Ebury Press • BISAC: Parenting - MotherhoodWelcome to the wild, messy, wonderful world of parenting--where the nights are long, the diapers are explosive, and unso...

View full details
The Outsider by Vir Das

The Outsider

Vir Das

₹455
₹699
₹699
₹699
(-35%)
₹455
₹455

• Author(s): Vir Das • Publisher: HarperCollins Publishers India • Publisher Imprint: HarperCollins Publishers India • BISAC: Entertainment & Performing ArtsComedian and actor Vir Das is beloved (by some, tolerated by others, blocked by a few...

View full details
The Very Hungry Caterpillar by Eric Carle

The Very Hungry Caterpillar

Eric Carle

₹293
₹450
₹450
₹450
(-35%)
₹293
₹293

• Author(s): Eric Carle • Publisher: Penguin Books, Limited (UK) • Publisher Imprint: Penguin Books, Limited (UK) • BISAC: Animals - Butterflies, Moths & CaterpillarsEric Carle's The Very Hungry Caterpillar is a perennial favourite with child...

View full details
Too Good to Be True : A smart, funny will-they-won’t-they romance by mostlysane by Prajakta Koli

Too Good to Be True : A smart, funny will-they-won’t-they romance by mostlysane

Prajakta Koli

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Prajakta Koli • Publisher: Harper Fiction India • Publisher Imprint: Harper Fiction India • BISAC: Romance - ContemporaryWinner of the Amazon India Popular Choice Debut Book 2025 Award. From one of India's most-loved creators comes s...

View full details
Home
Genres
Account
Chat