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Advancing Pharmaceutical Quality Guide: Change Management System
Chelemedos, Lori, Denny, Andrew, DiGiulio, Denise, Frederick, Tami, Huber, Tim, Jeffreys, Harry, Peszek, Jennifer, Spillman, Clayton Lee, Valentino, Jo Anne
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Advancing Pharmaceutical Quality Guide: Corrective Action and Preventive Action (CAPA) System
Chelemedos, Lori, Denny, Andrew, Ford, Kira, Frederick, Tami, Gujarathi, Ketan, Spangler, Blaine
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Advancing Pharmaceutical Quality Guide: Management Responsibilities and Management Review
Cromwell, Tisha, Frederick, Tami, Goldfinger, Marci, Greer, Steven, Grischeau, Michael, Matje, Robert, McClain, Lorraine, Valentino, Jo Anne, Walcott, Veda K., Winship, Bryan
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Baseline Guide Volume 1: Active Pharmaceutical Ingredients
Angelucci, Louis, Armstrong, Melody, Auyeung, Benny, Brennan, Thomas, DeNisco, Ross, Fortune, Dennis, Fritschel, Betsy, Koch, Karl, Koller, Norman C., Kuzian, Carole, Le Meur, Pierre, Linder, John, Mason, Phil, McNab, Gregor, Meisch, Art, Melton, Trish, PhD, Moore Jr., Donald R., Newberger, Stanley, Nichols, John, Roberts, Andrew, Shelley, Simon, Sipe, Eric, Stoker, Andrew, Ward, Anthony, Whalley, Edmund, Wood, James P., Wong, Patrick
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Baseline Guide Volume 2: Oral Solid Dosage Forms (Third Edition)
Chu, Jack C., PE/MBA, DiProspero, Dave, Matje, Robert E., CPIP, Becker, Douglas C., Docherty, Pamela Bruen, Carroll, Bernard J., PE, Colucci, Sam, PE, CEM, LEED AP BD+C, Cox, James, Cragnolini, Thomas, DeBellis, Mike P., Denk, Richard, Dugdale, Gary, BEng (Hons) CEng MIET, Egan, Brian J., Egee, Paul S., Flückiger, Andreas, Goldschmidt, Norman A., Goswami, David, Gross, Dennis M., MS, PhD, Hansen, Michael, Heisterkamp, Alex, Hillel, Uri, Jacobs, Terry A., AIA, Lashendock, Mark, Mallo, Tim A., PhD, Marshall, Peter, CEng, MI-ChemE, Martinez, Jaime E., Nakayama, Shugo, O'Brien, Paul, O'Brien, Vince, Patterson, John T., Penko, Aimee, Rockwell, Bruce, Rückert, Markus, Ruiz, George A., BEChe, Shnayder, Leonid, PE, Singhai, Sunil Chan
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Baseline Guide Volume 3: Sterile Product Manufacturing Facilities (Third Edition)
Cebular, Vincent J., Collins, Jason S., AIA, Goldschmidt, Norman A., Huber, Thomas M., Leichter, Gordon, PhD, Myers, Christa B., Poisson, Patrick J., Roy, Robert L., PE, VonEsch, Matthew P.
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Baseline Guide Volume 4: Water and Steam Systems (Third Edition)
Augustine, Robert, Baird, Andrew, Bevilacqua, PhD, Anthony, Cohen, Nissan, Coleman, Robert C., Evans, Jamie, Fischer, Diana, Freeman, W. Roderick, Gonzalez, Michelle, Hagopian, Brian, CPIP, Kehati, Ariel, Manfredi, Joseph, McClellan, Brian, Peterson, Chris, Pochini, Brian, CPIP, Sackstein, Shlomo, Shanahan, Ian, Soli, T.C., PhD, Sumner, Philip E., Thoendel, Roland, Walker, John, Whitehead, Paul, PhD, Widov, Anders, Wisniewski, Steve, Zoccolante, Gary
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Baseline Guide Volume 5: Commissioning and Qualification (Second Edition)
Ames, Chris, Baker, Tiffany, Block, Joerg, PhD, Brunelle, Ronald, Cameron, Graham, Christensen, Peter Werner, Eleskandarani, Hazem, PE, Haycocks, Nicholas, Kim, Lori, Lawrence, Glenn, Myers, Bob, Pieri, Xavier, Redmond, Alice, Rezac, Mark E., PE, Ruiz Quiones, Ramon, Simpson, Ghenet, van der Steen, Frank, Whipple, Michelle, Wisniewski, Steven
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Baseline Guide Volume 6: Biopharmaceutical Manufacturing Facilities (Second Edition)
Bowen, Robert J.E., Brunen, Manfred, PhD, Goldschmidt, Norman A., Miller, Steven, R., Pelletier, Marc P., PhD, Probst, Dr. Scott T., St. Onge, Kevin, von Stwolinski, Mark, Zwolenski-Lambert, Wendy
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Baseline Guide Volume 7: Risk-Based Manufacture of Pharma Products (Second Edition)
Naumann, Bruce D., PhD, DABT, Wilkins, Stephanie A., Dolgin, David D., Forsyth, Richard, Goldschmidt, Norman A., Shamez, Rizwan, PhD
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Comprehensive Guide to Clinical Materials
Carney, Charles F., DeAngelis, Nicholas J., PhD, DeVito, Kristen, Devreux, Vincent, Gore, Joan, Grevatt, Doug, Hadley, Jill, Meyer, Kristin, Mooney, Craig, Noblitt, Timothy, Nydell, Jennifer, Overstreet, Steven, Spataro, Maureen E., Stiffler, Debbie, Sweeney, Mike, Tate, Lynn, Wheeler, William, PhD, Zaret, Efram H., PhD
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D/A/CH Affiliate Handbook: Production of Water for Injection without Distillation (English Translation)
Bischof, Thomas, Clever, Michael, Eckart, Carolina, Frey, Jessica, Fuchs, Leonard, Herbelssheimer, Thomas, Hörmann, Philipp, Krain, Joachim, Kreutzenbeck, Peter, Kuntzmann, Eric, Lausecker, Alexander, Letzner, Hans-Hermann, Minzenmay, Andreas, Neumann,Stephan, Parisi, Alejandro, Raabe, Stefan, Röder, Fritz, Roepenack, Ralf, Rücker, Thomas, Schmid, Roger, Schmidt-Nawrot, Jochen, Thöndel, Roland, Träger, Ulrich, Walcher, Bruno, Zehnder, Marcel, Zipfel, Patrick
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D/A/CH Affiliate: Containment Manual (English Translation)
Badack, Henryk, Collins, Dirk, Denk, Richard, Fleckenstein, Jürgen, Flükiger, Andreas, Gries, Stefan, Hahmann, Uwe, Herman, Friederike, Kleine-Koenig, Benedict, Kovats, Daniela, Lehmann, Frank, Maeck, Reinhold, Maintok, Michael, Pernau, Martin, Rauschnabel, Johannes, Rückert, Markus, Schilder, Gerhard, Schreiner, Andreas, Schuldt, Malte, Steidle, Barnhard, Wolka, Karsten, Ziska, Jörg
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GAMP 5 Guide: Compliant GxP Computerized Systems
Bredesen, Anders, Brooks, Sam, Buffi, Jay, Cappucci, Winnie, Cherry, Mark, Clark, Chris, Evans, Gail, Hambloch, Heinrich, Jones, Colin, Kane, Paige, Margetts, Tony, Perez, Arthur "Randy", Robertson, Peter, Samways, Kate, Selby, David, Wingate, Guy, Wyn, Sion
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GAMP 5 Guide: Compliant GxP Computerized Systems (German Translation)
Bredesen, Anders, Brooks, Sam, Buffi, Jay, Cappucci, Winnie, Cherry, Mark, Clark, Chris, Evans, Gail, Hambloch, Heinrich, Jones, Colin, Kane, Paige, Margetts, Tony, Perez, Arthur "Randy", Robertson, Peter, Samways, Kate, Selby, David, Wingate, Guy, Wyn, Sion
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GAMP 5 Guide: Compliant GxP Computerized Systems (Polish Translation)
Bredesen, Anders, Brooks, Sam, Buffi, Jay, Cappucci, Winnie, Cherry, Mark, Clark, Chris, Evans, Gail, Hambloch, Heinrich, Jones, Colin, Kane, Paige, Margetts, Tony, Perez, Arthur "Randy", Robertson, Peter, Samways, Kate, Selby, David, Wingate, Guy, Wyn, Sion
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GAMP 5: Une approche de la conformité des systèmes informatisés BPx basée sur les risques
Bredesen, Anders, Brooks, Sam, Buffi, Jay, Cappucci, Winnie, Cherry, Mark, Clark, Chris, Evans, Gail, Hambloch, Heinrich, Jones, Colin, Kane, Paige, Margetts, Tony, Perez, Arthur "Randy", Robertson, Peter, Samways, Kate, Selby, David, Wingate, Guy, Wyn, Sion
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GAMP Good Practice Guide: Calibration Management (Second Edition)
Cerezo, Miguel, Culyer, James, Dawson, Stephen, Diamond, Ivan, Doman, Matthew, Foss, Mark, Gandhi, Niketa, Hall, Ian, Hewett, Ray, Newton, Mark, Murray, John, Tollefsen, Robert, Smith, Tim, Vuolo-Schuessler, Lorrie
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GAMP Good Practice Guide: Computerized GCP Systems & Data
Gebhardt, Jenny, Henrichmann, Frank, Herrmann, Oliver, Kellings, Angelika, Mangold, Marina, Rollinger, Yvonne, Staib, Eric J., Stroebe, Maximilian, Wachtmann, Dieter
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GAMP Good Practice Guide: Enabling Innovation
Ashworth, Karen, Bierans, Carsten, Cherry, Mark, Clark, Chris, Ferrell, Stephen, Gunning, James, Henrichmann, Frank, Herrmann, Oliver, James-Martin, Paul, Martin, Kevin C., McDonagh, Andrew, McLellan, Elizabeth, Moussally, Khaled, Murphy, Ray, O’Brien, Donal, Osburn, Michael, Perez, Randy, Reid, Chris, Rutherford, Mike, Samardelis, Judith, Seest, Jens, Shitamoto, Ken, Tyrrell, Andy, Vidstrup, Anders, Vuolo-Schuessler, Lorrie, Wakeham, Charlie, Walton, Mark, Watson, Heather, Westphal, Anette, White, Christopher, Wingate, Guy, Wyn, Sion
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GAMP Good Practice Guide: Global Information Systems Control and Compliance (Second Edition)
Cappucci, Winnie, Clark, Chris, Evans, Gail, Jones, Colin, Perez, Arthur "Randy", Stokes, David, Vuolo-Schuessler, Lorrie, White, Christopher, Wyn, Sion
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GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems (Second Edition)
Adler, Rachel, Brandstetter, Peter, Dube, David M., Evans, Karen, Johnson, Craig R., Lee, Carol, Luong, Kiet T., McDowall, Bob, Newton, Mark, Samardelis, Judith S., Smith, Paul, Vuolo-Schuessler, Lorrie, Ward, Peter
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GAMP Good Practice Guide: GxP Process Control Systems (Second Edition)
Ashworth, Karen, Buchanan, Roger, Cherry, Mark, Chopra, Reetu, Falcon, Peter, James, David, Iles-Smith, Peter, Isherwood, Martin, Knott, Malcom, Laibacher, Walfraid, Mills-Baker, Hilary, Nolan, Brian, Polentes, Blaise, Reedtz, Bo, Smerdon, George, Tuxford, Sue, van Deursen, Rainer, Werling, Gerhard, Wingate, Guy
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GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition)
Ferrell, Stephen R., CISA, CRISC, Hjulmand-Lassen, Urik, Kinney, Shana D., Martin, Kevin C., Moholkar, Ashish, Osburn, Michael F., Perez, Arthur "Randy", Rutherford, Mike, Silva, Jason, Staib, Eric J., van Opstal, René, Vidstrup, Anders
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GAMP Good Practice Guide: Manufacturing Execution Systems
deSpautz, Joseph, Donaldson, Karen, Iovino, Justin, Irving, Paul, Kanczewski, Ed, Kovacs, Kenneth S., Lerner, David, Pfitzenmaier, Allan, Ruklic, Gregory
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GAMP Good Practice Guide: Operation of GxP Computerized Systems
Alexander, Karen, Cappucci, Winnie, Lawrence, Pam, Lewis, Scott, Loscombe, Christopher, Mafemba, Munya, Reid, Chris, Harrison, Elizabeth, Samways, Kate, Sanders, Genni, Stafford, James, Stephenson, Rob, Topham, Simon, Wakeham, Charlie
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GAMP Good Practice Guide: Operation of GxP Computerized Systems (German Translation)
Alexander, Karen, Cappucci, Winnie, Lawrence, Pam, Lewis, Scott, Loscombe, Christopher, Mafemba, Munya, Reid, Chris, Harrison, Elizabeth, Samways, Kate, Sanders, Genni, Stafford, James, Stephenson, Rob, Topham, Simon, Wakeham, Charlie
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GAMP Good Practice Guide: Regulated Mobile Applications
Anderson, Erik, Clark, Chris, Bergvall, Niklas, Cappucci, Winnie, Dupont, Christophe, Jones, Colin, Perez, Arthur "Randy", Price, Chris, Stokes, David, Wyn, Sion
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GAMP Good Practice Guide: Testing GxP Systems (German Translation)
Ashley, Kevin, Ashworth, Karen, Buchanan, Roger, Davey, Jonathan, Dawson, Stephen, Heintzman, Angille K., Mewborn, Daniel G., Montgomery, Daniel, Ramesh, Radha, Sanders, Genni, Smerdon, George, Smith, Paul, Stanton, Kimberly, Stokes, David, Subramanian, Thanabalan, Theobald, Matthew, Tinson, Steve, Topham, Simon, Vidstrup, Anders, Waddick, Linda, Wakeham, Charlie
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GAMP Good Practice Guide: Testing GxP Systems (Second Edition)
Ashley, Kevin, Ashworth, Karen, Buchanan, Roger, Davey, Jonathan, Dawson, Stephen, Heintzman, Angille K., Mewborn, Daniel G., Montgomery, Daniel, Ramesh, Radha, Sanders, Genni, Smerdon, George, Smith, Paul, Stanton, Kimberly, Stokes, David, Subramanian, Thanabalan, Theobald, Matthew, Tinson, Steve, Topham, Simon, Vidstrup, Anders, Waddick, Linda, Wakeham, Charlie
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GAMP Guide: Records & Data Integrity
Clark, Chris, Jones, Colin, Margetts, Tony, Newton, Mark, Perez, Arthur "Randy", Price, Nigel, Reid, Chris, Rutherford, Mike, Vuolo-Schuessler, Lorrie, Wakeham, Charlie, White, Christopher, Wingate, Guy, Wyn, Sion
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GAMP Guide: Records & Data Integrity (German Translation)
Clark, Chris, Jones, Colin, Margetts, Tony, Newton, Mark, Perez, Arthur "Randy", Price, Nigel, Reid, Chris, Rutherford, Mike, Vuolo-Schuessler, Lorrie, Wakeham, Charlie, White, Christopher, Wingate, Guy, Wyn, Sion
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GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
Andrews, Sam, Ballman, Erika, Bass, George, Diamond, Ivan, Dillman, Robert, Ding, Sophie Zhiyao, Evgrafov, George, Ford, Kira, Frederick, Tami, Harringer, Elmar, Hattwig, Volker, Herrmann, Oliver, Labas, Paul, Longden, Heather, Margetts, Anthony, McManus, Barry, Paul, Leslie A., MS, Schmitt, Siegfried, Schröder, Shaw, Doug, Stephenson, Rob, Vuolo, Michelle, Vuolo-Schuessler, Lorrie, Wakeham, Charlie
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GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
Andrew, John, Ashworth, Karen, Chopra, Reetu, Dimitriadis, Kristina, Frederiksen, Brian, Granoša, Željko, Irving, Paul, Mills-Baker, Hilary, Murray, Steve, Ruklic, Gregory, Smillie, Catherine, Stokes, David, Thempadiyil, Rajesh, Vidstrup, Anders, Vuolo-Schuessler, Lorrie, Wakeham, Charlie, Wölbeling, Christian
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GAMP RDI Good Practice Guide: Data Integrity by Design
Ashida-Druar, Petch, Brawner, Matt, Buchanan, Roger, Dillman, Rob, Henderson, James, Jones, Stuart, Kane, Paige, Longden, Heather, Maher, Charles H., III, McDowall, Bob, McMenamin, Matt, Mukherjee, Anubha, Newton, Mark, Schenk, Levi, Stephenson, Rob, Vuolo-Schuessler, Lorrie, Wakeham, Charlie
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Good Practice Guide: Assessing Particulate Containment (Second Edition)
Abromovitz, Marc, Farris, John, Floura, Hari, Flueckiger, Andreas, Marshall, Peter, CEng, MI-ChemE, Meiners, Matthew, Petroka, George S., CIH, CSP, Sussman, Robert, Taylor, Barbara, Wood, James P.
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Good Practice Guide: Asset Management
Anderson, Michael, CMRP, Baldwin, Matthew J., Bryan, Steve, Cheney, Michael S., Hughes, John S., Morris, Scott D., O’Brien, Stephen E., Richardson, Dr. Phillip, Smith, Robert
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Good Practice Guide: Booklet Labels
Behrends, Brigitte, Glynn, David, Gram, Karen, Lingbeek-Brummelhuis, Kirsten, Lorck, Claudio, Lories, Pierre, Muller, Phillippe, Seesing, Marloes, Sonnenberg, Sascha
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Good Practice Guide: Clinical Supply Systems
Bielmeier, Petra, Gautam, Anurag, Gilson, Matthew, Junker, Henryk, Meyer, Douglas, Minogue, Greg, Montoya, Eddie, Riege, David, Schroeder, Sandee, Scott, Andrew, Young, Jeff
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Good Practice Guide: Cold Chain Management
Arrighi, Luca, Edmond, Jean-Pierre, Glauser, Geoffrey, Harber, Paul, Haycocks, Nicholas, Lee, Brian, Marinez, Elizabeth, McMenamin, Matthew, Mustafa, Neritan, Oliver, John, Oliver, Karen, Rijpkema, Douwe, Saxton, Brian W., Schnipper, Ted N., Seeley, Jeff, Spendley, Walt, Susla, Carol, Venturi, Brian, Vezina, Jean, Wallin, Brian, Wingate, Guy, Wrigley, Graham C., PhD
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Good Practice Guide: Commissioning & Qualification of Pharma Water & Steam Systems (Second Edition)
Augustine, Robert M., Cohen, Nissan, Fischer, Diana, Freeman, W. Roderick, Gonzalez, Michelle M., PE, Haycocks, Nicholas, Lewis, Fred, Schiller, Fred, Vishton, Peter T., PE, Widov, Anders, Wisniewski, Steven J., Zoccolante, Gary
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Good Practice Guide: Comparator Management
Bochert, Eva-Maria, Butta, Chris, Junker, Henryk, Roy, Sarbari, Swarts, Julie, Ware, Mark
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Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
Axelsson, Robert, Backx, Ivo, Barnum, Roger A., Baxter, Thomas, Bertuzzi, Guia, Bogaerts, Ivan, Bonnassieux, Alexandre, Brandon, Jenna K., Brodbeck, Paul, Busche, Stefan, PhD, Connelly, Gregory, PhD, Dale, Steven, Dhenge, Ranjit M., Dinarello, Eric, DiProspero, Dave, Egan, David, Elkes, Richard, Gandolfi, Nicola, Ganesh, Dr. Sudarshan, Hanson, Joshua M., Hausner, Douglas B., PhD, Hörmann-Kincses, Theresa, Howard, Rachelle, PhD, Jayjock, Eric, PhD, Khinast, Johannes, Kumar, Ashish, Lenich, Bob, Lewis, John C., PE, McCann, Ryan J., PhD, Meier, Dr. Robin, Michaelis, Dr. Marc, Minardi, Marco, Nitert, Dr. Bart, Ruff, Ronald, Sacher, Stephan, Schaller, Barbara E., Stranzinger, Dr. Sandra, Tantuccio, Anthony S., Teske, Andreas, Valluri, Sridhar, Verelst, Jan, Wareham, Laura
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Good Practice Guide: Controlled Temperature Chambers (Second Edition)
Arrighi, Luca, Bradley, Mike, Daniel, Paul, Garg, Abhishek, Moss, Derek, Rainbolt, Dean, Najera, Dinora, Pegington-Chow, Sarah, Roman, Nathan, Swann, James, Tasiyana, Shadreck
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Good Practice Guide: Critical Utilities GMP Compliance
Augustine, Robert M., Cox, Brian, du Kamp, Stuart, Freeman, W. Roderick, Kehati, Ariel, Krpan, Nik, Manfredi, Joe, Manku, Dave, O’Callaghan, Samuel, Röder, Fritz, Soli, Teri C., PhD, Thoendel, Roland, Tomoney, Nancy
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Good Practice Guide: Decommissioning Pharma Equipment & Facilities
Foss, Mark, Franklin, Daniel G., CIRM, CxA, Gampper, Brett, Haycocks, Nicholas, Johnson, Diana K., Knight, Gary A., Loke, Raymond, Mol, Xavier, O'Donnell, Mark Andrew, Petroka, George S., CIH, CSP, Schnattschneider, Andreas, van der Steen, Frank, Wisniewski, Steven J.
Book
Good Practice Guide: Development of Investigational Therapeutic Biological Products
Banerjee, Amit, Brownell, Elise, Candler, Roy, Carney, Charles F., Casnocha, Susan, Chrisco, LeeAnn, Cobb, Jackie, Das, Tapan, DeVito, Kristen, Dick, Rodney, Finken, Gerald "Jerry", Goman, Mike, Hopper, Randy, Hutchens, Clarice, Kay, Stephen, Key, Vivian, Ku, Michael, McCormick, Ellen, Mensah, Paul, Micklewright, Althea, Mott, John, Nema, Sandeep, Pluschkell, Steffi, Ramasubramanyan, Natrajan, Small, Lisa, Smith, Robert
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Good Practice Guide: Equipment Reliability
Berkey, Michael, Byrne, John, Harris, Thomas, Smith, Robert, Teimourian, Hamid, Tree, Richard, Yu, Alfred Ao
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Good Practice Guide: Good Engineering Practice (Second Edition)
Bennett, Chip, Block, Joerg, Drinan, Mark, Gentilini, Fabio, Jalal, Taha, Lawrence, Glenn, Milner, Craig, Muench, Mark, Varghese, Midhu, White, Stephanie, Wisniewski, Steve
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Good Practice Guide: Heating, Ventilation, & Air Conditioning (HVAC)
Goldschmidt, Norman A., Moore Jr., Donald R., Blazewicz, Bernard, Gantz, William A., Gardner, Peter B., Haycocks, Nicholas, Koller, Norman C., Roberts, Ronald, Schnipper, Ted N.
Book
Good Practice Guide: HVAC & Process Equipment Air Filters
Barbieri, Chris, PE, Bharadwaj, Rahul, Bryan, Eugene, Coughlin, Kimberly, Devine, Steve, Gantz, William, Hale, Dean, Haycocks, Nick, Largent, Don, Milholland, Dan, Moore, Donald, O’Reilly, Sean, Osborne, Mike, Phillips, David, Roberts, Ron, Solmaz, Hasim, Stillo, Andy, Thornburg, Don, Warner, Lisa, Windley, Shawn
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Good Practice Guide: Interactive Response Technology
Abdelkafi, Chedia, Anderson, Jerry, Arnold, Michael, RPh, Bradley, Ted, Brand, Adam, Britland, Sue, Conway, Lynn, Davis, Ethan, PMP, Eli, Massimo, Feliz, Miguel, Flynn, Gayle, Foust, Michelle, Gasman, Charles, Geiger, Fiona, Gerritsen, Jeroen, Gram, Karen, Jacobs, Steve, Junker, Henryk, Keating, Madaline, Lamb, Rongvald, Larrabee, Patricia, Lingbeek-Brummelhuis, Kirsten, Litzinger, Lauren, Mazuk, Katie, McDermott, Donna, McEntegart, Damian, Meyer, Julia, Milligan, Christine, Pal, Vijay, Pfefferkorn, Heidi, Ramuthaga, Nathaniel, Ribic, Michael, Robinson, Alan, Schultz, Tom, Seesing, Marloes, Shaver, Angela, Smith, Robert, Soulakian, Sandy, Swinney, Justine, Tsang, Louisa, White, Lekishia, Yoder, Steve
Book
Good Practice Guide: Investigational Medicinal Product Reverse Logistics
Gordon, Neal A., PhD, Groleau, Edward, Hall, Catherine, MS, MBA, Hottell, Greg
Book
Good Practice Guide: Knowledge Management in the Pharmaceutical Industry
Blacha, Patrick, Byrne, Melanie, Calnan, Nuala, Friedrichsen, Stephanie, Greene, Anne, PhD, Hallinan, Frank, PhD, Kane, Paige, PhD, Kumar, M. Narendira, Lipa, Marty, MS, Ramy, Ahmed, PhD
Book
Good Practice Guide: Maintenance (Second Edition)
Franklin, Dan, Harris, Thomas, Lacey, Michael, Lai, Tim, Neumann, Stephan, Ortega, Peniel, Rodriguez, Constantino, Teimourian, Hamid, Yu, Alfred Ao
Book
Good Practice Guide: Management of Engineering Standards
Becker, Jonathan, Derrett, Christopher, Fluharty, Jeffrey S., Fluke, Bryan W., Glanville, Jacqueline, McBride, Francesca A., Mowrey, Duane A., Smith, Frank J., Wegrzyn, Joseph P.
Book
Good Practice Guide: Non-Investigational Medicinal Products (NIMPs)
Acharya, Ajay, Bergqvist, Anneli, Calnan, Ann, Cruz, Miriam, Degennaro-Culver, Fran, DeVito, Kristen, Falzone, Lisa, Gardner, Beth, Harloff, Christine, Karstadt, Kay-Christian, Kulmburg, Peter, Lundin, Dawn, Main, Karen, Miller, Lee, Muller, Lars, Orosz, Peter, Roy, Sarbari, Sadler-Williams, Esther, von Steiger, Hans, Zobel, Andrea
Book
Good Practice Guide: Operations Management
Abell, Chris, Ashibi, Terts, Cardoso, Enric Jo, Chang, Carrollynn, Cruset, Alain, Curry, Jim, Davies, Nick C., DiVasto, Robert, PE, Fertig, Kristin, Granosa, Zeljko, Guillett, Brian, Iliopoulos, Theodore, Kisielnicki, Wojciech, Kulkarni, Niranjan, McKiernan, Jim, Mercuri, Marzio, Neal, Rodney, Pochini, Brian, CPIP, Primes, Gary, Ramos, Rey, Ravizzini, Giuseppe, Reed, Carla, Sanderson, Gareth, Santiago, Evelyn, Seymour, Patricia, Shelton, Marty, Stamm, Dennis, Weisemann, Claus, Williams, Glen
Book
Good Practice Guide: Ozone Sanitization of Pharma Water Systems
Aebi, Stefan, Battat, Ben, Bevilacqua, Anthony, PhD, Brown, Will, Ciufia, Vince, Cohen, Nissan, Gethard, Ken, PhD, Gobulukoglu, Ismail, PhD, Gonzalez, Michelle M., PE, Gray, David M., Harrison, Tony, Kettlewell, Richard, LaVoice, Bill, Manfredi, Joseph, McCarthy, Neil, Neri, Robert, Runyon, Reune, Schilling, Barbara, Sipe, Cameron, Soli, Teri C., PhD, Sumner Jr., Philip E., PE, Sundstrom, Hans, Vecchione, Robert, Vishton, Peter T., PE, Zoccolante, Gary
Book
Good Practice Guide: Packaging, Labeling, & Warehousing Facilities
Bahr, Mel, Cheesman, David, Egan, Tom, Eguchi, Makato, Gustafsson, Jan, PhD, Haycocks, Nicholas, Holton, John, Ilsoe, Christian, Lanman, Barbara, McBride, Linda, Moore Jr., Donald R., Reed, Chuck, Saxton, Brian W., St. Laurent, Nancy, Swaim, David, von Stwolinski, Mark, Whitby, Paul, Williams, David
Book
Good Practice Guide: Process Gases
Akerlindh, Katrin, Coffey, Tracey, DePaul, Joseph, Emmett, Roger, Gonzalez, Michelle M., PE, Haycocks, Nicholas, Johnston, Wade, Larkin, Tom, Larrabee, Chad, Martin, Jerold, Smelser, Bonnie, van der Steen, Frank, Vishton, Peter T., PE, Nicholson, Ian
Book
Good Practice Guide: Process Validation
Barrick, Joanne, Beall, Robert, Bergum, James, Breen, Christopher C., Corbishley, Paul, Hansen, Mette Kraemmer, Jiang, Canping, Lundsberg-Nielsen, Line, McMenamin, Matt, Parks, Thomas, Parlane, Maurice, Patel, Pritesh, Pazhayattil, Ajay Babu, Pfahler, Lori B., Scherder, Tara, Smith, Lauren, Somayajula, Dilip Ayyala, Stepinac, Thomas, Vukovinsky, Kim, Wade, Jonathan Brett, Walsh, Jenn, Wiles, Fred
Book
Good Practice Guide: Project Management for Pharmaceutical Industry
Angelastro, Jamie, Barlow, David, Butler, Jeffrey H., Davies, Nick C., Errico, Stephen, Gibbs, Keith, Gunderlock, Rich, Honey, John, Hura, Leo, Iles-Smith, Peter, Kelly, Sean, Koncak, Dave, Lamson, Keith, Loxley, Paul, Lynam, Mick, McCann, Chris, McGlade, James W., Melton, Trish, PhD, O'Donnell, Kevin, Odum, Jeffrey N., CPIP, Penfold, Alf, Phelan, Joe, Roberts, Andrew, Scherzer, Raymond H., Shelden, Wade, Spanel, Greg, Stefanowicz, Matt, Theobald, Matthew, Thorne, Ian
Book
Good Practice Guide: Quality Laboratory Facilities
Butler, Mark A., Craft, Mary Ellen, Creaven, Thomas J., Daou, Cesar B., PE, DeFreitas, Donna A., Dolceamore, James J., Ferguson, William E., PhD, Fricke, Frederick L., Gardner, Peter B., Gonzalez, Michelle M., PE, Guillorn, Gerard J., Jacobs, Terry A., AIA, Master, Kaushik S., Middelber, Catherine E., O'Brien, James M., Smith, Euan D., Snyder, Kimberly D., Tewalt, Gregory L., PhD
Book
Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases
Baumstein, Michael, Freeman, W. Roderick, Gill, Andre, Gonzalez, Michelle M., PE, Hagopian, Brian, CPIP, Kjems, Jeppe, Manfredi, Joseph, Ochoa, Ruby, Palinvelu, Aravind, Pochini, Brian, CPIP, Soli, Teri C., PhD, Sumner Jr., Philip E., PE, Tomaselli, Michael, Tomoney, Nancy, Vestermark, Michael, Vishton, Peter T., PE, Widov, Anders
Book
Good Practice Guide: Single-Use Technology
Ballal, Swapnil, Belattar, Malik, Goldstein Sr., Adam, Mahajan, Ekta, Mignot-Moraux, Katell, Perrone, Pietro, PhD, PE, Smalley, Christopher J., Wolton, David AR
Book
Good Practice Guide: Technology Transfer (Third Edition)
Aldington, Suzanne, Browning III, Mervin H. (Vinny), MS, Caraballo, Jose A., Cohen, Mike, Davis, Bruce, Haas, Beth, Herberger, John, Kikegawa, Corinne, Parline, Maurice, Thombre, Ruchi, Troccoli, Noreen, Vazquez-Rey, Maria, Vrolijk, Nick
Book
Guide: ATMPs – Autologous Cell Therapy
Bannon, Tom, Baratta, Phil, Bozenhardt, Erich, Caraballo, Jose A., Cebular, Vince, Cicalese, Pinar, Davis, Bruce, Davis, Lesley, Doppstadt, Andrew, Fleming, Paul, PMP, Goldschmidt, Norman, Herwig, Christoph, Kulkarni, Niranjan, PhD, Lera Anton, Arantxa, Odum, Jeff, CPIP, Pelletier, Emilie, Pochini, Brian, Schröder, Prof. Dr. Christa, Weinstein, AaronISPE
Book
Guide: Biopharmaceutical Process Development and Manufacturing
Dream, Robert, PhD, PE, CPIP, Clerecuzio, Charles A., Disi, Sharif, Kutza, Joseph, PhD, Odum, Jeffrey N., CPIP, Orichowskyj, Stephan T., Rayner, Andrew C., Wirt, Gary D.
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Guide: Cleaning Validation Lifecycle – Applications, Methods, & Controls
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Handbook: Sustainability
Bowen, Robert J.E., Begonis, Dennis, Cantor, Justin, Dream, Robert, PhD, PE, CPIP, Farquharson, Gordon, Gardner, Peter B., Gonzalez, Michelle M., PE, Haycocks, Nicholas, Leani, Paolo, Sumner Jr., Philip E., PE, Testoni, Cristina, Trapl, Josef, Tvrdinic, Johannes, Wander, Kacy, Wheeler, Martin, Wilson, Ian, Zoccolante, Gary
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Japan Affiliate: Pest Control Manual (English Translation)
Adachi, Fumio, Ishibuchi, Shingo, Umayahara, Junichi, Otake, Hiroyuki, Onishi, Hitoshi, Ogawa, Hiroyasu, Oshita, Masayuki, Ozawa, Keiichi, Kato, Masaki, Kashimura, Kiyoshi, Kanahira, Daisuke, Kaneko, Yawara, Kagami, Kenji, Kanno, Satoshi, Kikuta, Kazuaki, Kikuchi, Masaya, Sawaya, Junichi, Shinohara, Taiki, Aratani, Ryoichi, Sumitani, Kazumi, Takao, Makoto, Takahashi, Toshiyuki, Hayakawa, Kazuhisa, Hiraga, Taizo, Fujii, Kentaro, Fujinaga, Hajime, Maeda, Takaaki, Marubashira, Yuto, Miyahara, Toshio, Watanabe, Naoki
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Product Quality Lifecycle Implementation Guide: Change Management System
Choi, Michael, Boedecker, Bernd, Hughes, Rob, Hamilton, Lilian, Myles, Claire, Schebler, Susan L., James, Mike, Takashima, Takeshi, Taticek, Ron, Tewalt, Gregory L., PhD
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Product Quality Lifecycle Implementation Guide: Process Performance & Product Quality Monitoring System
Brown, Winston R., Cai, Chunsheng, PhD, Famulare, Joseph, Gehle-Novak, Jennifer, Gill, Jaspreet, Hughes, Rob, Lin, Claudia Q., PhD, Liptzin, Bryan, Martino, Steven J., Millili, George P., PhD, Orloff, Jason J., Potter, Christopher, PhD, Stellon, Ronald C., Venkateshwaran, Thirunellai G., PhD
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Product Quality Lifecycle Implementation Guide: Product Realization
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Product Quality Lifecycle Implementation Guide: Product Realization Illustrative Example
Ahuja, Eric, Alexander, Brett, Bryder, Mette, Busse, Sue, Cook, Graham, Davis, Bruce, Donaubauer, John, Groskoph, John, Hopkins, Sandy, Kourti, Theodora, Kraemer-Hansen, Mette, Lepore, John, Lundsberg-Nielsen, Line, Nosal, Roger, Potter, Christopher, PhD, Stott, Paul, Tyler, Stephen, Watson, Timothy
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