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Cleaning Validation Guideline

Cleaning Validation Guidelines

This document on Cleaning Validation is intended to address special considerations and issues Womens Von Miller Jersey pertaining to validation of cleaning procedures for equipment used in the manufacture of pharmaceutical products, radiopharmaceuticals, and biological drugs. The document is also intended to establish inspection consistency and uniformity with respect to equipment cleaning procedures. This topic reflects an area in pharmaceutical, biological and radiopharmaceutical manufacturing that is noted as being important by both the Inspectorate and the pharmaceutical industry. This guideline has been prepared to provide guidance to inspectors, evaluators and industry in reviewing the issues covered. Utilization of this information should facilitate compliance with Division 2 Part C of the Regulations to the Food and Drugs Act.It is not intended that the recommendations made in these guidelines become requirements under all circumstances. Information provided in the document for limits to be applied in defined circumstances as well as the number of batches to be utilized for cleaning validation studies is for guidance purposes only. Inspectors, evaluators and industry may consider other limits if proposed and documented in accordance with appropriate scientific justification.3.1 The objective of the cleaning validation is to verify the effectiveness of the cleaning procedure for removal of product residues, degradation products, preservatives, excipients and/or cleaning agents so that the analytical monitoring may be reduced to a minimum in the routine phase. In addition one needs to ensure there is no risk associated with cross contamination of active ingredients.3.2 Cleaning procedures must strictly follow carefully established and validated methods.3.3 Appropriate cleaning procedures must be developed for all product contact equipment used in the production process.3.4 Relevant process equipment cleaning validation methods are required for biological drugs because of their inherent characteristics (proteins are sticky by nature), parenteral product purity requirements, the complexity of equipment and the broad spectrum of materials which need to be cleaned.3.5 Cleaning procedures for products and processes which are very similar do not need to be individually validated. This could be dependent on what is Authentic Von Miller Jersey common, equipment and surface area, or an environment involving all product contact equipment.It is considered acceptable to select a representative range of similar products and processes. The physical similarities of the products, the Authentic Ryan Clady Jersey formulation, the manner and quantity of use by the consumer, the nature of other product previously manufactured, the size of batch in comparison to previously manufactured product are critical issues that justify a validation program.A single validation study under consideration of the worst Von Miller Jersey case can then be carried out which takes account of the relevant criteria.For biological drugs, including vaccines, bracketing may be considered acceptable for similar products and/or equipment provided appropriate justification, based on sound, scientific rationale is given. Some examples are cleaning of fermenters of the same design but with different vessel capacity used for the same type of recombinant proteins expressed in the same rodent cell line and cultivated in closely related growth media; a multi antigen vaccine used to represent the individual antigen or other combinations of them when validating the same or similar equipment that is used at stages of formulation (adsorption) and/or holding. Validation of cleaning of fermenters should be done upon individual pathogen basis.4.0 Validation of cleaning processes4.1 As a general concept, until the validation of the cleaning procedure has been completed, the product contact equipment should be dedicated.4.2 In a multi product facility, the effort of validating the cleaning of a specific piece of equipment which has been exposed to a product and the cost of permanently dedicating the equipment to a single product should be considered.4.4 It is usually not considered acceptable to test until clean. This concept involves cleaning, sampling and testing with repetition of this sequence until an acceptable residue limit is attained. For the system or equipment with a validated cleaning procedure, this practice of resampling should not be utilized.4.5 Products which simulate the physicochemical properties of the substance to be removed may be considered for use instead of the substances themselves, when such substances are either toxic or hazardous.4.6 Raw materials sourced Womens Ryan Clady Jersey from different suppliers may have different physical properties and impurity profiles. When applicable such differences should be considered when designing cleaning procedures, as the materials may behave differently.4.7 All pertinent parameters should be checked to ensure the process as it will ultimately be run is validated. Therefore, if critical temperatures are needed to effect cleaning, then these should be verified. Any chemical agents added should be verified for type as well as quantity. Volumes of wash and rinse fluids, and velocity measurements for cleaning fluids should be measured as appropriate.4.8 If automated procedures are utilized (Clean In Place: CIP), consideration should be given to monitoring the critical control points and the parameters with appropriate sensors and alarm points to ensure the process is highly controlled.4.9 Validation of cleaning processes should be based on a worst case scenario including:challenge of the cleaning process to show that the challenge soil can be recovered in sufficient quantity or demonstrate log removal to ensure that the cleaning process is indeed removing the soil to the required level, andthe use of reduced cleaning parameters such as overloading of contaminants, over drying of equipment surfaces, minimal concentration of cleaning agents and/or minimum contact time of detergents.4.10 At least three (3) consecutive applications of the cleaning procedure should be performed and shown to be successful in order to Ryan Clady Jersey prove that the method is validated.

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Chris Creighton named hea

Chris Creighton named head football coach at Eastern Michigan

Eastern Michigan issued a release tonight announcing Chris Creighton as the school's new head football coach:Chris Creighton, the head football coach at Drake University for the past six years, has been named the new head football coach at Eastern Michigan University, Vice President/Director of Intercollegiate Athletics Heather Lyke announced today, Dec. 11. Creighton will be formally introduced to the EMU community Thursday, Dec. with a press conference inside the atrium of the Convocation Center. The 44 year old Creighton has built the Bulldogs into a consistent power in the Pioneer Football League, sharing the conference crown during the 2011 and 2012 campaigns. During his 17 year head coaching career, he has accumulated eight conference titles and an all time record of 139 46 (.764 winning percentage). He departs Drake with the highest winning percentage in school history (.667) after also posting 63 wins as the head coach at Wabash College and 32 at Ottawa University. "It is with great pride that we introduce Chris Creighton as our new head football coach," Lyke said. "In Chris, Eastern Michigan will find an extraordinary leader who will be a great ambassador for our University. During the search process, Chris' focus on positively impacting the lives of our student athletes and building a championship program was most impressive. As a proven winner and head coach, Chris' experience with creating and sustaining success will inspire our student athletes to elevate our football program to a championship level." "I want to sincerely thank Heather Lyke, President Martin and the Board of Regents for entrusting me with the leadership of the Eastern Michigan University football program," said Creighton. "It is both a huge opportunity and responsibility and I am fired up about it. My vision is to make playing football at Eastern Michigan one of the most incredible experiences of our players lives. I cannot wait to meet the team and start a new journey with them." In his six seasons at the helm of the Bulldogs, Creighton racked up a 35 13 (.729) record in Pioneer Football League action and a 31 9 (.775) record the last five seasons. Just the seventh DU coach to win 40 or more games and the fastest to do so, Creighton needed just 60 games. In his time at Drake, Creighton boasted a 30 5 home record and a 21 2 home conference record going undefeated against five Authentic Demaryius Thomas Jersey conference opponents. Drake had an 11 game home win streak during Creighton's tenure as well as winning 16 straight home conference games with him at the helm. In 2013, the Bulldogs finished with a 6 5 record for their 10th consecutive winning season. Four players earned first team honors, five were named to the second team and two garnered a spot on the honorable mention team. Drake led the Pioneer Football League with 10 student athletes earning spots on the Academic All PFL teams. In 2012, he led the Bulldogs to their second straight Pioneer Football League title and the sixth PFL championship in program history with an 8 3 record and a 7 1 mark in league play. The 2012 team was led by one of his star pupils in record setting quarterback Mike Piatkowski. The signal caller set nearly every Bulldog single season and career passing mark under Creighton's tutelage. Seventeen Bulldogs earned All PFL honors following the 2012 championship and six were named to the PFL All Academic Team, including three student athletes that also garnered CapitalOne/CoSIDA Academic All District honors. A school record 63 Bulldogs were also named to the PFL Academic Honor Roll. In 2011, Creighton's fourth Bulldogs' team won nine games and tied for the Pioneer Football League title with a 7 1 conference record. It was Drake's fifth PFL crown and first since 2004. The Bulldogs' head coach was recognized for the job he did by being named one of 20 finalists for the 2011 Eddie Robinson Football Championship Subdivision (FCS) Coach of the Year Award. A league leading 18 Bulldogs received All PFL honors and a PFL best nine Drake student athletes were named Academic All PFL. In addition, a then school record 61 Bulldogs were named to the PFL Academic Honor Roll for achieving a grade point average of 3.0 or above. The energetic, but veteran coach was named a winner of the Giant Steps Award presented by the National Consortium for Academics and Sports as part of National Student Athlete Day on April 6, 2011. Creighton, awarded in the Coaching category, was one of just five 2011 winners of the Giant Steps Award, given annually to individuals who use sport to positively affect social change, actualizing the mission of the NCAS. The awards honor student athletes, athletic administrators, civic leaders, coaches, parents, Demaryius Thomas Jersey organizations, and other individuals who demonstrate an outstanding ability to manage life on and off the field, and who demonstrate a commitment to the betterment of society. During

his distinguished career, Creighton has taken great pride in the student athlete experience that transcends to the football field and the classroom. In his career, Creighton has taken his teams on three overseas trips, including a 2011 trip to Tanzania, to go along with ventures to Austria and Panama while head coach at Division Authentic Karl Mecklenburg Jersey III Wabash. Drake's two week experience in Africa in 2011 for the inaugural Global Kilimanjaro Bowl included significant service projects in orphanages and schools, the ascension of 19,340 foot Mt. Kilimanjaro and a victory over a Mexican collegiate all star team in the Kili Bowl the first game of American football played on African soil. With that trip setting the foundation for the Bulldogs' 2011 season, the team adopted the theme "Tupande Kileleni," a Swahili term that translates to "Let's climb to the summit." The summit, for Drake, became the quest to perform to its full potential and symbolized the climb to the top of the Pioneer Football League standings, which it achieved. The 2010 Bulldogs featured a defense that ranked sixth in the nation among FCS schools (2nd PFL) in rush defense (94.2), eighth (3rd PFL) in sacks (3.0) and 18th (2nd PFL) in tackles for loss (7.4). In addition, the special teams excelled in punt coverage (5th NCAA FCS/1st PFL, 3.4), kickoff coverage (5th NCAA/1st PFL, 16.1) and punt return average (15th NCAA/1st PFL; 13.53). Creighton's Bulldogs also featured eight players named to the Academic All PFL team (three 1st team, five 2nd team) and a then school record 55 earning a place on the PFL's Academic Honor Roll. In 2009, picked to finish sixth in the preseason coaches' poll, Creighton guided Drake to an 8 3 record, including a 6 2 third place finish in the Pioneer Football League. Drake matched its best nine game start in history (8 1) that year, while riding a six game mid season winning streak. Creighton's first Drake club in 2008 went 6 5 and finished in a tie for fourth in the PFL. Ranked fourth among all active NCAA Division III football coaches in career winning percentage upon his hire at Drake, Creighton served as head coach at Wabash College in Crawfordsville, Ind., from 2001 07 where he constructed a 63 15 record (.80 with his teams winning four North Coast Athletic Conference championships, while competing in three NCAA Division III playoffs. During his final three years at Wabash, Creighton led the Little Giants to a 30 5 record (.857) including three straight league championships and appearances in the 2005 and 2007 NCAA Division III playoffs. Wabash posted a 11 2 record in 2007, competing in the NCAA Division III playoffs while being ranked No. 8 in the final NCAA Division III coaches' poll. Wabash went 12 1 in 2002 and 11 1 in 2005, capping both seasons with appearances in the NCAA Division III playoffs. As offensive coordinator at Wabash, Creighton's teams averaged 35 points per game with the multiple offense producing the school's all time leading rusher and passer. Three starting quarterbacks received Karl Mecklenburg Broncos Jersey All America honors. Under Creighton, Wabash won conference championships in 2002, '05, '06 and '07. He coached 83 all conference players, including seven who earned conference player of the year honors, along with 13 All Americans. Creighton was named North Coast Athletic Conference Coach of the Year in 2002, '05 and '07, as well as the Kansas Collegiate Athletic Conference Coach of the Year in 1997. Creighton was head coach at Ottawa (Kan.) University from 1997 2000, compiling a record Womens Demaryius Thomas Jersey of 32 9 (.780). The San Francisco, Calif., native produced one of the greatest single season turnarounds in NAIA history during his first year at Ottawa in 1997. Inheriting a team that posted a record of 1 8 the previous season, Creighton guided his club to a 9 2 finish en route Karl Mecklenburg Jersey to capturing its first Kansas Collegiate Athletic Conference title since 1972. He also led Ottawa to a conference championship in 2000 along with appearances in the NAIA playoffs in '97 and 2000. Creighton served as offensive coordinator at Concordia (Ill.) from 1991 92 and Manchester (Ind.) from 1993 96 before becoming head coach at Ottawa. In 1993, Creighton was the head coach and quarterback of the Limhamn Griffins in Malmo, Sweden, as he helped guide the franchise to its first national championship. As an All America quarterback, Creighton led Kenyon (Ohio) College to its only North Coast Athletic Conference title in 1989 and was named conference player of the year after setting single season conference records for passing yardage (2,843) and touchdowns (29). He was inducted into the Kenyon College Athletic Hall of Fame in 2008. Creighton earned a Bachelor of Arts degree from Kenyon College in 1991 and a master's degree from Concordia (Ill.) University in 1993. Creighton is the first active head coach to be hired at Eastern Michigan since Jim Harkema in 1983. Harkema was the head coach at Grand Valley State University (1973 82) before taking over the EMU program

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Another mobile QB stands b

Another mobile QB stands between Hawkeyes and success

JACKSONVILLE, Fla. When discussing the biggest challenges facing the Iowa football team in Friday's TaxSlayer Bowl, Kirk Ferentz brings up the "M'' words.

The Hawkeye coach talks Maryland, he talks Minnesota and in doing so, he talks mobile quarterbacks.

Ferentz said Dobbs and the Volunteers' offense remind him a lot of the looks his team struggled with this season, dual threat quarterbacks who can beat you with their arm and their feet. Brown threw for 120 yards and ran for 99 more in the Terrapins' 38 31 win over Iowa on Oct. 18.

Three weeks later, Minnesota's Mitch Leidner completed 10 of 13 passes for 138 yards and four touchdowns in addition to gaining 77 on the ground in the Golden Gophers' 51 14 win over the Hawkeyes.

He expects the same from Dobbs, an aeronautical engineering major who has engineered productive offensive performances while leading Tennessee to wins in three of the four games he has started this season.

"They would be foolish not to attack us in a similar manner,'' Ferentz said. "I'm sure we'll get tested in the same way. The question is, can we respond to that? Can we do a better job of taking away some of the things that hurt us in those two games?''

Dobbs has the potential to create similar issues for the Iowa defense. game, Dobbs has directed an offense which has averaged 35 points and 424.3 yards per game.

The 6 foot 3, 216 pound Georgia native has had a lot to do with the team's success. In the five games he has played, he has thrown for 1,077 yards and rushed for 393 while running for six of Cheap NFL Jerseys the 14 touchdowns he has had a hand in.

In Tennessee's last game, a 24 17 win over Vanderbilt, Dobbs threw for 93 yards and ran for 91.

"Things did change when he became our quarterback. Joshua presents us with a very unique skill set, obviously with his ability to run the football, but also to do some different things in the throw game,'' Volunteers coach Butch Jones said. "You are always adapting and adjusting to the strengths of your players and there is enough flexibility in our offense to do things which allow us to utilize his abilities.''

Ferentz believes Dobbs has been a big Wholesale Jerseys reason for the late season surge that allowed Tennessee to finish 6 6 and qualify for a bowl in a season which saw the Volunteers start seven true freshmen two games ago against Missouri.

"He's been a big part of what makes them go,'' Ferentz said. " He presents a unique challenge and we know that we will have to be at our best defensively. That's where it begins.''

Iowa linebacker Quinton Alston said during a Wednesday news conference that Dobbs will test not only the Hawkeyes' fundamental skills, but the team's discipline.

"The good thing is that we've had a month to prepare, a month to concentrate on developing the communication it takes to be successful against a quarterback like that,'' Alston said. "We've seen already what can happen when that doesn't happen. Now the challenge is to learn from those games and put what we've learned to use.''

Defensive tackle Louis Trinca Pasat said the Hawkeyes must remain true to their assignments if they hope to contain and control Dobbs.

"It's all about trusting the guy next to you to do his job and making certain that you fulfill your own responsibilities,'' Trinca Pasat said. "That's where it starts and where it ends.''

Alston believes the Hawkeyes have made progress in that area, developing effective communication that will strengthen the group as a whole.

"We must play our game, do what we are required to do and let our teammates do their jobs, too,'' Alston said. "He's a good quarterback, and they have good players around him, so for us it will start Cheap Jerseys with our fundamentals and being strong there. We need to be up to the challenge.''

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