Seminar on Validation and Troubleshooting of Pharmaceutical Water Systems

 Description:

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don’t work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn’t recur.

Why you Should attend:

Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it.

Who Will Benefit:

This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the “true” whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are:

  • Microbiology Laboratory supervisors and analysts responsible for water sampling and testing
  • Quality Assurance personnel responsible for water system deviation management and change control
  • Regulatory and Compliance professionals responsible for FDA interactions
  • Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation
  • Facility Engineers responsible for water system design or renovation

Agenda:

Day 1 Schedule

Lecture 1:

What Makes Water Systems Have Microbial Quality Problems

  • Understand biofilm basics and how it develops
  • Understand the impact of biofilm on the commonly used purification unit operations
  • Understand how various commonly used microbial control strategies work (or don’t work) to control biofilm development
  • Understand the how, where, and why of microbial monitoring, action levels, etc.
  • Debunk a few water system myths
  • Get answers to your own water system questions

Lecture 2:

Successful Sanitization Approaches for Trouble-Free Water Quality

  • Material and construction limitations
  • Continuous vs intermittent sanitization
  • The importance of biofilm removal
  • How sanitants work (or don’t work)
  • When to sanitize
  • Troubleshooting sanitization problems

Lecture 3:

Water System Validation by Logic Instead of Tradition

  • Why validate a water system?
  • Basic ground rules for water systems before you validate them
  • Micro Test Method “validation”
  • Minimum validation expectations
  • How to figure out what you should validate
  • What happens after the honeymoon is over
  • Is validation ever really over?
  • Special considerations for lab water systems
  • Are packaged waters a viable option?

Lecture 4:

Implementing Changes to a Validated System

  • Purpose of a Change Control program – a help, not a hindrance
  • When is a change major vs minor, requiring full vs limited re-qualification?
  • What about water use during re-qualifications?
  • FDA validation expectations
  • Reliance on logic and common sense and the disservice of precedent and paradigms
  • Additional useful tips

Lecture 5:

Reducing Water Microbial Excursions & Improving Investigations

  • What are excursions?
  • Water system dilemma: process control or quality control (utility or raw material), or both
  • Intended roles of Alert/Action Levels and Specifications
  • Investigation, necessary and often fruitless
  • Excursion responses and impact
  • Criticality of valves, hoses, & outlet flushing
  • Diagnosing the source of the problem
  • Minimizing unnecessary excursion responses through best practices

Day 2 Schedule

Lecture 6:

Understanding and Controlling Endotoxin

  • Where does endotoxin come from?
  • What are the properties of endotoxin?
  • How do you get rid of it?
  • How do you detect it?
  • What assay controls are used?
  • What are the endotoxin specs for water?
  • How do you control it?

Lecture 7:

Harmonizing vs Optimizing Water Microbial Testing for System Quality Control

  • Water harmonization that has occurred
  • Water Micro TM “Dis-Harmonization”
  • A little about Biofilm
  • Biofilm diversity in water systems
  • Micro TM options and evaluation protocol
  • The good and bad of Micro harmonization
  • Where RMMs can fit in
  • Parting wisdom

Lecture 8:

Microbial Enumeration Issues with High Purity Water Systems

  • Microbial Enumeration Issues with High Purity Water Systems
  • Biofilm enumeration issues (planktonic vs surface)
  • Traditional cultivative approach issues
  • Validation of your test method
  • Alternative TM choices (advantages/disadvantages)
  • Significance of water isolates
  • Sampling issues
  • Establishing Alert/Action Levels and Water Specs and defending them to FDA

Lecture 9:

Water System Investigation “How-To’s” and Example Case Studies

  • Gathering and assessing existing data and symptoms
  • Considering user opinions
  • Investigation approach elements
  • Recognizing red herrings/false positives
  • Recognizing possible root causes
  • Water system contamination case studies
  • Parting kernels of water system wisdom

Lecture 10:

What USP Does and Doesn’t Say about PW, WFI, Pure Steam and Micro Issues

  • PW, WFI, Pure Steam micro specifications?
  • <1231> Starting water issues
  • <1231> Misunderstood issues clarified
  • <1231> Microbiological test issues clarified
  • <1231> Suggested micro test method
  • <1231> Micro Specifications
  • <1231> Alert and Action Levels and max’s
  • Recent/Upcoming USP water changes
  • Discrepancies between pharmacopeia’s

 

Speaker:

Dr Teri C. Soli

Principal Consultant, Soli Pharma Solutions

T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. offering troubleshooting and training expertise covering water systems, sterilization, sterile and non-sterile manufacturing, microbiological laboratories, and microbial and beta-lactam contamination control. He has 38 years of pharmaceutical experience as a consultant and with operating companies including DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer.

His career-long water systems and contamination troubleshooting experience, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems.

Location:  Philadelphia, PA Date: April 23rd & 24th, 2019 and Time: 9:00 AM to 6:00 PM

Venue:  DoubleTree by Hilton Philadelphia Airport, 4509 Island Avenue, Philadelphia, PA 19153

 

 

Price:

1 ATTENDEE $2,000, Register for 1 attendee

5 ATTENDEES $10,000, Register for 5 attendees

10 ATTENDEES $20,000, Register for 10 attendees

Until March 20, Early Bird Price: $2,000.00, From March 21 to April 21, Regular Price: $2,200.00

 

Sponsorship Program benefits for seminar

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Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

globalcompliancepanel@gmail.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

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RPS says pharmacists must always be present in pharmacies

The three RPS national boards have jointly called for legal guarantees that a pharmacist will always undertake a clinical assessment or check, and that there must be no legal loopholes that can bypass this requirement.

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Source: Alamy.com

The leaked document, prepared by a working group of the Department of Health’s Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board, suggested that current legislation could be changed to allow a registered pharmacy professional, which could include a technician, to take responsibility for the sale and supply of pharmacy and prescription-only medicines.

The Royal Pharmaceutical Society (RPS) has said it believes a pharmacist should always be present in a pharmacy, apart from occasional short periods of time.

Responding to a leaked document produced for the Department of Health (DH) on the issue of whether pharmacy technicians should be allowed to supervise pharmacies, the RPS has issued an eight-point position statement on the role of registered technicians supervising the sale and supply of medicines.

Read More: http://snip.ly/3pujp#http://www.pharmaceutical-journal.com/news-and-analysis/news/rps-says-pharmacists-must-always-be-present-in-pharmacies/20203609.article

Pharmacist in deadly meningitis outbreak heading to trial

Pharmacist in deadl

After watching his mother die from meningitis in a nationwide outbreak caused by contaminated steroids, Scott Shaw is determined to make sure something like that never happens again.

A stiff punishment for the Massachusetts pharmacist Shaw believes is partially responsible may help, he says.

“I believe as surely as I’m talking to you right now that if something isn’t done, we will repeat this again,” the North Carolina man said.

Glenn Chin, the supervisory pharmacist at the now-closed New England Compounding Center in Framingham, about 22 miles (35 kilometers) west of Boston, is to go on trial Tuesday for his role in the 2012 fungal meningitis outbreak that killed 76 people and sickened hundreds of others.

Chin faces up to life in prison if convicted of all counts of second-degree murder under federal racketeering law.

Experts, and Chin’s defense attorney, believe prosecutors have a stronger case against Chin than they did against the co-founder of the compounding pharmacy, Barry Cadden. Cadden was sentenced in June to nine years in prison after being acquitted of second-degree murder charges but convicted on conspiracy and fraud charges.

Chin ran the so-called clean rooms where steroid injections were made. He is accused of failing to properly sterilize the drugs, among other things. Chin also faces conspiracy, mail fraud and other charges.

“I’m just a little concerned that the judge and the jury might be a little more harsh on Glenn Chin because he was doing the work in the clean room,” Chin’s attorney, Stephen Weymouth, said.

Throughout Cadden’s trial, the co-founder’s lawyers tried to push the blame onto Chin. Chin intends to point the finger back at Cadden.

Weymouth said he will argue that Chin was essentially a “puppet” for Cadden, who made working in the clean rooms so difficult that “mistakes might have been made.” Cadden was the one calling the shots and pushing the orders to line his own pockets, Weymouth said.

 

Read More: http://snip.ly/kx5et#http://abcnews.go.com/US/wireStory/pharmacist-deadly-meningitis-outbreak-heading-trial-49907214

US pharmaceutical company expands Dublin presence

US pharmaceutical company expands Dublin presence

PTC Therapeutics, a US pharmaceutical company, plans to expand its European headquarters in Dublin to 40 staff.

The Dublin site of the company is responsible for finance, quality assurance, legal and a raft of other back office roles.

“We currently employ 30 people in the Dublin office and this will increase to a total of 40 sustainable jobs in this office within a short period of time,” said Adrian Haigh, who heads up the company’s international operations.

PTC focuses on the discovery and commercialisation of novel medicines. It has been working on the development of a drug called Translarna for almost 20 years. The drug is the only protein restoration therapy for the treatment of nonsense mutation Duchenne Muscular Dystrophy – a genetic disorder characterised by progressive muscle degeneration.

 

Read More: http://snip.ly/qmou7#https://www.irishtimes.com/business/health-pharma/us-pharmaceutical-company-expands-dublin-presence-1.3212652

Marketing and promotion of drugs and medical devices

Regulation of the promotional aspects of prescription drugs, biologics, medical devices and biotechnology products with the intention of ensuring

Regulation of the promotional aspects of prescription drugs, biologics, medical devices and biotechnology products with the intention of ensuring that the information contained in the promotion material is not false or misleading is one of the chief objectives of the FDA.

The FDA regulates the promotional materials of all drugs, and this includes both labeling and advertisements. Brochures, booklets, detailing pieces, bulletins, calendars, motion pictures and slides are some of the examples of labeling, while materials published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television and telephone communications systems are examples of advertising.

The FDA also regulates another avenue of drug promotion and advertising, namely detailing. This kind of promotion is the one that pharma companies do to doctors in a variety of venues such as medical offices, hospitals, pharmacies, at medical meetings and symposia, academic settings, conferences and other meeting facilities.

The FDA’s reach in monitoring and regulating promotions also covers direct-to-consumer (DTC) prescription drug advertising. In this area, it has complete jurisdiction over prescription drug labeling and advertising and all medical device labeling, but has limited jurisdiction over medical device advertising.

Severe penalties for offenders

For decades, the FDA has been regulating traditional advertising, during the course of which it has been publishing several kinds of guidance documents for industry, and has issued many violation letters. The corrective actions that companies have to implement if the FDA adjudges that drug or medical device promotional material is false or misleading or does not give a proper account of the product needed to enable consumers to weigh the benefits and risks are very expensive and time consuming. They have to carry out expensive remedial advertising, have to cough up huge fines, and also face the prospect of having their reputation sullied on account of these enforcement actions from the FDA.

In addition, it can also criminally prosecute relevant executives of such organizations under the provisions of a strict liability standard. This law gives the government sweeping powers, by which it is not obliged or required to show that the executive facing prosecution had the intention of violating FDA regulations or was knowledgeable about such violations.

The agency has already netted billions of dollars in fines, forfeitures and disgorgements from drug companies for the alleged marketing of a product for unapproved, or “off-label,” uses.

Are the FDA’s laws obsolete?

Yet, the general consensus is that the law governing drug and device marketing is both outmoded and insufficient to deal with the speed at which technology-enabled promotion campaigns appear out of nowhere and disappear in a jiffy. Experts feel that the FDA is still very conservative and traditional in adapting technologies needed for detecting and nailing down such promotion campaigns that technology has brought about. Naturally, the regulatory circles are eager to see how the FDA will deal with the advanced communication technology that goes into promotion campaigns that can make the advertisement go viral and leave the scene just as quickly.

These are important aspects for organizations in the drugs, biologics, medical devices and biotechnology areas. These companies need to be completely aware of the law governing advertising and need to understand the FDA’s thinking on what it considers false and misleading advertising. This knowledge is absolutely essential, considering the broad sweep of powers that the FDA has.

Important learning on the FDA’s approach to promotions and advertising

This important understanding will be imparted at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. At this seminar, David R. Dills, Global Regulatory Affairs and Compliance Consultant, who provides regulatory affairs and compliance consultative services, will be the Director. To gain insights into the FDA’s thinking on how it perceives advertisements and promotions as false and misleading, please register for this seminar by visiting Marketing and promotion of drugs and medical devices. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Advertising aimed at healthcare professionals and consumers

Prescription drug promotion is aimed at and delivered to two distinct audiences: Health care professionals (HCPs) and consumers. The FDA recognizes that promotional efforts can provide these audiences important information about the newest developments in drug therapies. So, it insists that such information has to have integrity and completeness.

Also, healthcare professionals, sales representatives and consumers use the social media to discuss the use of prescription products for specific diseases and conditions, a factor that has to be taken into account. David will discuss this and the potential concerns it carries.

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

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Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till April 30. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit https://www.globalcompliancepanel.com/seminar?wordpress_SEO and use MGCP50 Promo Code.

This offer is valid till April 30, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

 

 

FDA guidance on process validation

FDA guidance on process validation

The FDA guidance on process validation is an important document that offers guidelines on Process Validation (PV), a critical aspect of medical device and pharmaceutical manufacturing.

In November ’08, the FDA issued a draft guideline that revised the old guidelines on PV. The FDA guidance on process validation was now the standard that replaced the FDA guidance on process validation that was in force from 1987.  FDA guidance on process validation underwent another revision in January 2011, which is now the current standard. It has altered the spirit of the earlier documents in a few ways.

January 2011 changes

  • It now gives greater emphasis to use ICH Q 8, 9 and 10;
  • The term ‘commercial manufacturing’ has come to replace the old word, ‘commercial production’. This means a significant change in the scope of the ICH.
  • The January 2011 FDA guidance on process validation has also given a slightly different definition of PV and Stage 1 and Stage 2.
  • The new FDA guidance on process validationdescribes PV as “The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”

Why did the FDA change guidelines on PV?

The FDA guidance on process validation underwent changes because it was observed during its investigations that drugs of inferior quality were being marketed even though they were manufactured under less demanding processes, which were being passed off as “validated”.

Manufacturers need to ask these:

In essence, FDA guidance on process validation requires manufacturers to ask themselves these questions:

  • Which scientific evidence I have used gives me the confidence that my process is capable of consistently and repeatedly delivering quality product?
  • Can I show that my process works as intended?
  • What are the ways by which I can know that my process has remained in control?

References:

http://www.gmp-compliance.org/eca_news_2380_6764,6864,6917,6971.html

http://www.gmp-compliance.org/eca_news_2600.html

 

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