Seminar on Cleaning Validation Regulatory Requirements and Principles

  • September 26, 2016
  • 309 Views
  • 26 Comments
  • 1 Likes
Seminar on Cleaning Validation Regulatory Requirements and Principles

Course "Regulatory Requirements and Principles for Cleaning Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.  The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a Cleaning Validation Master Plan and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.

Why should you attend?

Attendance at 2 day seminar will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.  Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful.         

Areas Covered in the Session:

  • Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product
  • Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections
  • Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
  • Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies

Who will benefit:

Attendance at 2 day seminar will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.

Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful.

  • Senior Quality Managers
  • Quality Professionals
  • Production Supervisors
  • Validation Engineers
  • Process Owners
  • Quality Engineers
  • Quality Auditors

 

Agenda:

Day 1 Schedule

Lecture 1:

FDA Requirements and Industry Standard Practices

Lecture 2:

How to Develop/Review your Cleaning Procedures and the Adequate Selection of Cleaning Agents and Parameters

Lecture 3:

How to Develop a Cleaning Validation Policy/Program

Lecture 4:

How to Implement a Robust Cleaning Validation Plan

Day 2 Schedule

Lecture 1:

Laboratory Issues in Cleaning

Lecture 2:

Microbiological aspects of a cleaning validation program for manufacturing equipment

Lecture 3:

Keys to Cleaning Validation Maintenance Remaining Compliant

Lecture 4:

Current FDA concerns about validation of cleaning processes

Speaker:


Joy McElroy

Principle Consultant, Maynard Consulting Company

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Up John performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.

Now with 12 years experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.

Joy specializes in Equipment Qualification, Cleaning Validation,Sterilization, Environmental Monitoring, and GMP Compliance Auditing.

 

Location: Washington, DC Date: September 22nd & 23rd, 2016 and Time: 09:00 AM to 06:00 PM

 

Venue: WILL BE ANNOUNCED SOON

 

Price:

 

Register now and save $200. (Early Bird)

 

Price: $1,295.00 (Seminar Fee for One Delegate)

 

Until August 20, Early Bird Price: $1,295.00 from August 21 to September 20, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)

 Until August 20, Early Bird Price: $6,475.00 from August 21 to September 20, Regular Price: $7,475.00

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

 

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com      

Website: http://www.globalcompliancepanel.com

Registration Link - http://bit.ly/29xrg1v-Regulatory-Requirements

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel

 


Recent Comments

KerryLus 11 Days ago / Delete / Reply

where to buy viagra over the counter uk
online viagra
viagra online bestellen zoll
[url=http://fastshipptoday.com/#]viagra online[/url]
viagra sale ireland

ManuelImive 10 Days ago / Delete / Reply

where to buy original viagra
viagra tablets
where to get viagra in pune
[url=http://fastshipptoday.com/#]viagra coupons[/url]
viagra for men price

RichardBen 10 Days ago / Delete / Reply

generic term for viagra
online viagra
viagra cheap no prescription
[url=http://fastshipptoday.com/#]buy generic viagra[/url]
viagra available in generic

Justinabutt 10 Days ago / Delete / Reply

best place buy sildenafil citrate
viagra prices
comprar sildenafil sandoz 100 mg
[url=http://fastshipptoday.com/#]viagra tablets[/url]
using cialis with viagra together

Danielmek 9 Days ago / Delete / Reply

is 20mg cialis equal to 100mg viagra
buy viagra
viagra 25 mg sildenafil citrate
[url=http://fastshipptoday.com/#]viagra for sale uk only[/url]
viagra while trying to get pregnant

payday loan no credit check 9 Days ago / Delete / Reply

payday loans massachusetts
[url=https://loanswayer.com/]payday advance[/url]
payday loans with payment plans
online loans
day payday loan

Gilbertember 9 Days ago / Delete / Reply

ordering generic viagra online
viagra coupons
viagra sales for pfizer
[url=http://fastshipptoday.com/#]viagra pills[/url]
price comparison viagra levitra

WillieHut 8 Days ago / Delete / Reply

short term loan bad credit
[url=https://loanswayer.com/]loan online[/url]
online loan for bad credit
same day payday loans no credit check
loans online fast

WilmerKardy 8 Days ago / Delete / Reply

costo viagra 25 mg
buy viagra online
can you take viagra xanax together
[url=http://fastshipptoday.com/#]viagra cost[/url]
who gets free viagra

Russelwrawn 7 Days ago / Delete / Reply

need a fast loan
[url=https://loanswayer.com/]online payday loans[/url]
how does cash advance work
payday loans bad credit
new payday loan lenders

JosephTruro 7 Days ago / Delete / Reply

vorst- m50 mg sildenafil
viagra prices
can a 21 year old get viagra
[url=http://fastshipptoday.com/#]viagra sans ordonnance[/url]
viagra orders online

Marionnip 7 Days ago / Delete / Reply

generico viagra
viagra prices
buy viagra online in bangalore
[url=http://fastshipptoday.com/#]viagra on line[/url]
posologia sildenafil 50 mg

StevenCEABS 7 Days ago / Delete / Reply

how to buy viagra safely online
viagra cost
golden viagra 3800 mg
[url=http://fastshipptoday.com/#]viagra uk[/url]
can i buy viagra over the internet

JoshuaJoymn 6 Days ago / Delete / Reply

where to order cialis
cost of cialis
cialis pills for women
[url=http://waystogetts.com/#]buy cialis[/url]
buy generic viagra cialis levitra

Davidtub 5 Days ago / Delete / Reply

cheapest cialis world
cost of cialis
buy cheap cialis online uk
[url=http://waystogetts.com/#]generic cialis at walmart[/url]
cialis sale online australia

Ronaldteets 5 Days ago / Delete / Reply

generic cialis for sale in the u.k
generic cialis
want buy cialis uk
[url=http://fkdcialiskhp.com/#]cialis online[/url]
how to buy cialis in london

Bernardslura 4 Days ago / Delete / Reply

how to cut cialis pills
tadalafil generic
buy viagra and cialis online
[url=http://fkdcialiskhp.com/#]cialis generic[/url]
buy cialis canada online

Brianclemi 3 Days ago / Delete / Reply

buy cheap cialis link online
cialis online
cialis online buying
[url=http://fkdcialiskhp.com/#]buy cialis[/url]
buy viagra cialis or levitra

RichardShada 3 Days ago / Delete / Reply

cash loans for people with bad credit
http://microgama.com/index.php/component/k2/itemlist/user/83929
personal loans fresno ca
[url=http://zandenstrand.com/index.php/nl/component/k2/itemlist/user/86233#q]pay day loan lenders[/url]
online loans in texas
http://aestetic.su/index.php/component/k2/itemlist/user/57049
online loans no credit
[url=http://ferienhausnordseekuste.com/index.php/nl/component/k2/itemlist/user/86654#g]new loan[/url]
how to get a money loan
http://espacio-eme.com/component/k2/author/41718
online loans direct lender
[url=http://walnutseedlings.com/?option=com_k2&view=itemlist&task=user&id=5256#z]how do personal loans work[/url]
loan payday
http://www.preetitalati.com/?option=com_k2&view=itemlist&task=user&id=13541
new payday loans
[url=http://fasthosting.com.au/?option=com_k2&view=itemlist&task=user&id=4311#m]i need a small loan[/url]
payday loans omaha ne
http://mealware.be/?option=com_k2&view=itemlist&task=user&id=10142
personal loans baton rouge
[url=http://maricsekteam.hu/?option=com_k2&view=itemlist&task=user&id=134830#u]payday now loans[/url]
personal loans direct lenders
http://carlyleconstruction.ca/?option=com_k2&view=itemlist&task=user&id=60114
1 hour payday loans
[url=http://wahlitho.com.my/?option=com_k2&view=itemlist&task=user&id=459920#r]loans for payday[/url]
bond loans bad credit
http://jpnatc.org/?option=com_k2&view=itemlist&task=user&id=30711
emergency cash loan bad credit
[url=http://smkbandarbintulu.edu.my/index.php/component/k2/itemlist/user/25154#h]payday loans online direct lenders only[/url]
money to pay bills
https://pereplanirovka.by/?option=com_k2&view=itemlist&task=user&id=12555
cash advance columbus ohio
[url=http://www.masters.ru/?option=com_k2&view=itemlist&task=user&id=2141688#v]payday loans augusta ga[/url]
bad credit loan lenders
http://husbilsguiden.se/?option=com_k2&view=itemlist&task=user&id=21939
payday loans newport news va
[url=http://dikobruk.mserwer.pl/?option=com_k2&view=itemlist&task=user&id=227785#p]need personal loan[/url]
personal loan for poor credit
http://archassurance.com/?option=com_k2&view=itemlist&task=user&id=48706
legitimate payday loans online
[url=http://shahrdari-nashtarood.ir/component/k2/itemlist/user/2699.html#q]new payday loans[/url]

Matthewsilky 2 Days ago / Delete / Reply

cialis for sale in the philippines
buy cialis
generic cialis pills e20
[url=http://fkdcialiskhp.com/#]generic cialis at walmart[/url]
buy cialis in the uk

Patrickabors 2 Days ago / Delete / Reply

viagra 100 mg sildenafil citrate
buy viagra online
price on viagra
[url=http://bgaviagrahms.com/#]viagra online[/url]
viagra products sale

JorgeFus 2 Days ago / Delete / Reply

viagra sale point pakistan
viagra online
buy cheap viagra uk
[url=http://bgaviagrahms.com/#]cheap viagra[/url]
buy viagra in usa

JesseDom 1 Days ago / Delete / Reply

viagra buy generic
viagra prices
can you get viagra over the counter in the us
[url=http://bgaviagrahms.com/#]viagra prices[/url]
viagra online in the usa

RalphFlugh 1 Days ago / Delete / Reply

list of payday loan lenders
http://santetoujours.info/?option=com_k2&view=itemlist&task=user&id=4670272
online loan services
[url=http://dijitalpazarlamauzmani.com/?option=com_k2&view=itemlist&task=user&id=5413#p]new payday loans[/url]
personal loan application
http://www.micobiota.cl/?option=com_k2&view=itemlist&task=user&id=25300
bad credit rating loans
[url=http://www.eat-well-live-well.co.uk/?option=com_k2&view=itemlist&task=user&id=22116#x]payday loans tulsa ok[/url]
payday loans fort wayne
http://titoyayo.com/?option=com_k2&view=itemlist&task=user&id=36796
apply for a personal loan
[url=http://www.msofficegurus.com.br/?option=com_k2&view=itemlist&task=user&id=9778#d]5000 personal loan with bad credit[/url]
christmas loans
https://www.semisrael.com/?option=com_k2&view=itemlist&task=user&id=122055
bad credit cash loans
[url=http://zartabco.com/?option=com_k2&view=itemlist&task=user&id=24455#b]payday loan in las vegas[/url]
same day payday loans direct lenders
http://mobility-corp.com/?option=com_k2&view=itemlist&task=user&id=587187
speed cash loan
[url=http://pelletsolutions.eu/?option=com_k2&view=itemlist&task=user&id=739344#l]easy payday loan[/url]
top pay day loans
http://unisonuclh.org.uk/?option=com_k2&view=itemlist&task=user&id=35155
online loans same day
[url=http://www.gourmetpastrytp.com/index.php/component/k2/itemlist/user/8496#o]indiana payday loans[/url]
personal loans banks
http://www.ptklaster.eu/?option=com_k2&view=itemlist&task=user&id=137011
fast payday loan online
[url=http://solutioneering.co.uk/?option=com_k2&view=itemlist&task=user&id=50638#t]money lender[/url]
online loan applications
http://meencantapensarcontigo.com/?option=com_k2&view=itemlist&task=user&id=40993
loans till payday
[url=http://shop.durbanwebdesign.com/?option=com_k2&view=itemlist&task=user&id=17713#d]paydayloans[/url]
online loan apply
http://monmo.ru/?option=com_k2&view=itemlist&task=user&id=15126
how can i get cash fast
[url=http://hotelsissy.gr/?option=com_k2&view=itemlist&task=user&id=516115#h]easy to get personal loans[/url]
need a loan bad credit
http://www.educalo.es/?option=com_k2&view=itemlist&task=user&id=146819
get cash
[url=http://www.automotivacestari.com.br/?option=com_k2&view=itemlist&task=user&id=28672#s]pay day online[/url]

HarlanGAR 17 Hours ago / Delete / Reply

cheapest levitra generic
generic levitra
buy levitra in india
[url=http://bmflevitramke.com/#]generic levitra[/url]
cheap levitra canadian pharmacy

CharlesBeT 2 Hours ago / Delete / Reply

order levitra super active oo
levitra 20 mg
cheap viagra levitra
[url=http://bmflevitramke.com/#]buy levitra[/url]
levitra cheap online

Leave a Comment