Where does GMP Training end and HR training begin?

HR could be in a predicament about what kind of training to impart to consultants.

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That pharmaceutical companies need to hire professionals with the requisite qualifications is beyond question. This is not only required for the smooth conduct of activities in their course of their day-to-day work, but also because the FDA has set out its requirements for the proper educational and skill set qualification of employees in this profession in 21 CFR 211.25(a).

This FDA section underlines the need for educational qualifications, training and experience to carry out their job functions, which cannot be carried out in the absence of these requirements. The consequences of having ill qualified and ill-equipped staff can be of a grave nature. This scenario calls for a thorough look at the way pharmaceutical companies select and train their staff engaged in their work that must incorporate Good Manufacturing Practices (GMPs), while also maintaining quality, which is of paramount importance in this industry, all within the ambit of the organizational culture.

Challenging questions relating to training requirements

Meeting the educational and training requirements for pharmaceutical professions in a GMP environment, while complying with the provisions of 21 CFR 211.25(a) can be quite a challenge for the pharmaceutical companies’ HR. HR training should align with the requirements set out by Quality Assurance. There must be consistency and alignment of the priorities and need of the stakeholders in these two crucial departments.

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HR could be in a predicament about what kind of training to impart to consultants, a practice that is quite prevalent in this industry. Are they to be trained the way regular staff is, or do they have a different set of training requirements? Another practice that abounds in this industry is transferred employees. What about the training for such employees?

Get to understand the elements of onboarding in a GMP environment

A webinar from MentorHealth, a leading provider of professional trainings for healthcare professionals, will be setting doubts relating to all these core areas at rest at a webinar that it is organizing. The speaker at this webinar is Michael Esposito, who has over 30 years of experience in the pharmaceutical industry, during which he has world in a variety of areas including packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations in many reputable companies such as Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson’s McNeil Consumer Healthcare Division. Michael has more than 17 years’ experience in GMP training and document management.

Please visit http://bit.ly/2HJdw93 to enroll for this very useful session.

Familiarization with the onboarding strategy

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The essence of this webinar is familiarization with the onboarding strategy needed for professionals in the pharma industry. Michael will help participants understand how to put in place an onboarding strategy that combines the inputs of all the major stakeholders and put in place a consistent and comprehensible onboarding and training process that the organization can adapt for its employees.

Participants at this webinar will be able to define the onboarding process in the context of compliance. Michael will help them understand how to interact with HR to create a coordinated onboarding strategy. They will be able to implement a training program that takes into account the differences between the training requirements for full-time employees and contractors, and between new employees and employees transferring internally. They will also be able to prioritize training, so that they not only ensure compliance; they also reduce the learning curve for new or transferred employees.

This session is of value to professionals such as Managers with direct reports, HR professionals, and Quality Assurance and training departments. Michael will cover the following areas at this webinar:

  • FAQs for employee onboarding
  • Management’s expectations for new employees
  • HR onboarding
  • Quality’s role in the onboarding process
  • GMP training requirements
  • Handling full-time employees vs. contractors and other temporary personnel

Benchmarks for training and competency.

PharmAbcine Announces FDA Orphan Drug Designation Granted to TTAC-0001

We are very pleased with this Orphan Drug Designation from FDA for TTAC-0001

PharmAbcine Inc., a clinical-stage biotech company developing novel antibody therapeutics for multiple cancer indications, announced today that U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its leading clinical compound TTAC-0001 for “treatment of Glioblastoma Multiforme.”

“We are very pleased with this Orphan Drug Designation from FDA for TTAC-0001 for GBM treatment since we have been preparing for clinical studies of TTAC-0001 plus KEYTRUDA® (pembrolizumab) combo therapy for recurrent GBM in addition to TTAC-0001 mono therapy for recurrent GBM progressed after bevacizumab treatment. It will accelerate the progress of TTAC-0001 to provide clinical benefit in the treatment of GBM,” said Dr. Jin-San Yoo, president and chief executive officer of PharmAbcine, Inc.

The FDA Office of Orphan Products Development grants Orphan Drug Designation to investigational drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including seven years of market exclusivity upon regulatory product approval, exemptions from certain FDA application fees, and tax credits for qualified clinical trials costs.

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About TTAC-0001 (=Tanibirumab)

PharmAbcine’s lead candidate TTAC-0001, an investigational therapy, is a highly selective and potent anti-VEGFR2 (KDR/flk-1) mAb in clinical development for rGBM indications. VEGFR2 is over-expressed in most malignant tumors, such as gastric, liver, non-small cell lung cancer (NSCLC), ovarian, brain, colorectal, and breast cancers and this signaling pathway is a key regulator for tumor angiogenesis.

Increased understanding of the role of VEGF/VEGFR2 in the tumor vessel formation, immune suppressive modulation of tumor micro environment (TME) and the function of the antagonist molecule to disorganized tumor vessel normalization, immune supportive modulation, and ultimately tumor vessel disruption, supports the rationale for evaluating TTAC-0001 in GBM, rGBM and Avastin® (bevacizumab) refractory GBM.

About PharmAbcine Inc.

PharmAbcine is a leading clinical stage biologics company that develops fully human therapeutic antibody (mAb) and next generation multispecific antibody therapeutics based on in-house developed novel platform, DIG-Body, PIG-Body and TIG-Body using innovative discovery technology and excellent human resources for the treatment of human diseases, such as cancer and inflammatory diseases.

PharmAbcine’s fully human antibody libraries and innovative selection system are our priceless proprietary assets. PharmAbcine provides antibody generation services by using antibody library and selection systems. PharmAbcine also provides co-development opportunities with novel antibodies.

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Under the collaboration with SAMSUNG MEDICAL CENTER, PharmAbcine has >300 patients derived cancer stem cell libraries and its animal model system for evaluating internal pipeline development.

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Understanding Medical Device inspection

The medical device inspection process is built on the logic that methods are not to be considered the criterion for evaluating and inspecting a medical device.

A medical device inspection is one of the most important activities the FDA carries out to determine that a device meets the requisite regulatory standards for ensuring safety and effectiveness. It is a core GMP activity and hence covers all medical devices ranging from the smallest to complex ones such as MRI’s.

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Rationale for the medical device inspection regime

The medical device inspection process is built on the logic that methods are not to be considered the criterion for evaluating and inspecting a medical device. This is because many methods can be used to arrive at the same product, due to which the choice of the best option is left to the manufacturer. Given this fact, the FDA medical device inspection concept is aimed at inspecting the device’s Quality System Regulations (QSR)-mandated objectives, which are a more precise parameter for medical device inspection.

What are manufacturers expected to demonstrate to a medical device inspection?A medical device inspection is done to ensure that the device meets set safety, efficiency and intended use standards, while being compliant with regulatory requirements. During the medical device inspection, manufacturers have to demonstrate that the method they have chosen to use -since there can be varied methods for arriving at a medical device specification -is helpful in arriving at the product while meeting the prescribed regulatory compliance requirements. They should defend the methods they have used in ensuring regulatory compliance requirements.

Need not meet all GMP requirementsOne major factor that the FDA keeps in mind for a medical device inspection is that manufacturers are not required to show compliance with each and every Quality System (QS) or GMP section. Only those that are relevant to that device can be shown, but they should be able show which sections of the GMP or QS are relevant to the said device, and should also show how these have been used to arrive at the product that is compliant in terms of regulatory requirements.

Factors a medical device inspection takes into considerationDuring a medical device inspection, the FDA inspectors keep in mind a few factors that help them determine the efficiency and effectiveness of a medical device. Some of the important ones among these include:

  • Has the manufacturer documented the processes in the right format? Has everything related to it been written down?
  • Is the manufacturer complying with those processes?
  • Is there sufficient evidence that these are adequate?

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Other issues for a medical device inspectionThe FDA does a medical device inspection keeping these factors in mind while also weighing other issues such as the size of the medical device manufacturing firm, the complexity of the device under inspection, and the nature and gravity of risk a device that does not meet its intended specifications poses.

An understanding of Pharmaceutical Regulatory Affairs

Pharmaceutical Regulatory Affairs can be said to have its origins in these events.

Regulatory Affairs sit at the center of an industry like pharmaceuticals. Given the importance this industry and the products its manufactures have on the health of human beings; it is imperative that there should be regulations in the industry at every stage of the process of manufacturing and marketing of pharmaceuticals.

pharmaceuticalRegulatoryAffairsThe primary aim of Pharmaceutical Regulatory Affairs is to ensure compliance with regulations that apply to every stage and process of the manufacturing and subsequent activities with the appropriate laws and regulations that apply to the industry.

Pharmaceutical Regulatory Affairs has evolved over a long time

Pharmaceutical Regulatory Affairs, like Rome, was not built in a day. The earliest attempts at making an activity or profession like Regulatory Affairs a discipline in itself can be traced to at least a century. The Diphtheria Epidemic of 1902 and a few other continental and global pharmaceutical disasters in subsequent years, such as the vaccine tragedy, sulfanilamide and thalidomide events made the authorities realize the need for framing initiatives to check the occurrence of such events. Pharmaceutical Regulatory Affairs can be said to have its origins in these events.

pharmaceuticalRegulatoryAffairsEssentially, Pharmaceutical Regulatory Affairs is about providing direction and focus to the strategy, tactics and operations aspects of the industry. It can be termed as a scientific system of surveillance. Pharmaceutical Regulatory Affairs concerns itself with every activity from start to finish and puts regulations in place to ensure that each activity is technically correctly carried out in accordance with these regulations and is in tune with sound scientific principles and practices.

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All round and comprehensive

The important point to note about Pharmaceutical Regulatory Affairs is that it deals with every stage of production, starting with procurement of the raw materials or molecules needed for developing the drug, the clinical trial process, the manufacturing process, the packaging, the marketing and even post-consumption of the product by patients, ensuring that along every step, scientific methods and best practices are adhered to and are in accordance with rules, regulations and requirements set out by the regulatory authorities.

Different set of regulations in different markets

In most cases, it is not only one regulatory body whose regulations and requirements need to be adhered to. When a pharmaceutical product has to be marketed globally, it has to meet the regulatory requirements of all the countries or markets in which it is being sold, individually, unless the rule specifies otherwise.

pharmaceuticalRegulatoryAffairsIn the process of working on all these, the Pharmaceutical Regulatory Affairs profession entails having to take steps to see to it that the product is in some way different from what already exists in the market. All these make Pharmaceutical Regulatory Affairs a challenging profession.

This being the case, Pharmaceutical Regulatory Affairs professionals have their own clearly defined roles on what they need to do in order to ensure that they carry out these activities.

Here the references :

http://www.ijprr.com/File_Folder/127-131%28ijprr%29.pdf

http://www.abpi.org.uk/our-work/mandi/Pages/regulatory.aspx

How I let drinking take over my life

Feeling neither happy nor sad, I raised the glass and swallowed the booze.

I had my last drink five years ago, in the early hours of the morning on 1 January 2013. I think it might have been around 2am. I wouldn’t have described myself as drunk. I would have said I’d had a few drinks. But I was drunk. If I had tried to drive, or write, or give a talk in public, I’d have done these things badly. Feeling neither happy nor sad, I raised the glass and swallowed the booze. It was some kind of fruit punch.

At the time, I didn’t think this would be my last drink. I thought it would be my last drink until my birthday, on 30 April. For 10 years, I’d spent the first four months of every year as a teetotaler. There had been two exceptions. One year I started drinking on 27 April, because I was in a houseboat in a harbour and I was offered a glass of wine. I hated myself for those three days. Another year I did not quit until March, but punished myself for that lapse with eight months of sobriety instead of the usual four.

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But maybe, I often thought, sobriety wasn’t exactly a punishment. I liked sobriety. I slept better. I lost weight. My skin became clearer. I definitely felt fitter. My concentration improved; I could buzz through a book in a few hours. My mind was sharper. I felt lighter, happier. I no longer turned up to appointments late, sweaty, reeking of alcohol. I had more time. I remember one conversation after 15 teetotal weeks; the guy I was talking to said he couldn’t believe how young I looked. He really meant it. Sobriety rejuvenates you like nothing else.

Then my birthday, my drinking day, would come around again. I’d have a sense of nervous anticipation, a queasy feeling that I didn’t want to start drinking again, combined with a queasy feeling that I did. In any case, I felt compelled to start drinking again; that was part of the deal I’d made with myself, because I really wanted to drink. I wanted to drink for precisely the same reason that I didn’t want to drink – because I had a drinking problem. Drink seemed to have a strange, brain-sucking power over me. On my birthday, I would wake up feeling the sort of anxiety you feel before a date or a party. I was going to start drinking again. Tonight, I would be in a different world.

When I try to explain my drinking problem, it goes like this: in my head, I was a moderate drinker, but after I’d had a drink, I wasn’t. The more I drank, the more I wanted to drink. Drinking increased my thirst. I wanted the second drink more than the first, and I wanted the fifth more than I’d wanted the fourth. My thirst always increased over the course of an evening. But it also increased, in a more subtle way, over the course of a month, a year, a decade. Drink added something, but it always seemed to subtract more than it added, and the only way I could get things back to normal was to drink more, and all this drinking began to wreck my mind. And then I’d stop, and I’d be sober for 120 days. Being sober felt great. So why did I always go back to drinking?

The first few days of sobriety provided a clue. On day one I’d wake up with a hangover. The next day I’d wake up with a phantom hangover. The day after that I’d wake up, and put my head under the duvet, waiting for the pain and the sickness. For a few seconds, my mind would be racing. What did I drink last night? How much did I get through? And then I’d remember: nothing. I drank nothing. And without the shroud of a hangover, my mind would feel strangely defenceless; any emotion could just barge in and march around for hours. In those moments, I understood something about why my drinking was a problem.

During the times I did not drink, I was not aware of wanting to drink. I did not crave it or sneak around and drink secretly. Being sober made me think of chainsmokers whose craving disappears on long-haul airline journeys. They know they can’t possibly smoke, so they just put the whole thing out of their minds.

Marc Lewis, a neuroscientist and addiction expert, told me it was the same thing as when you put a piece of meat in the fridge, and your dog paws at the door, whining and trying to force the door open. But if you convince the dog the door is locked, it will stop whining and walk away.

Every year, I stopped whining and walked away. I went to pubs and bars and drank fizzy water. In the evenings I drank tea. I saw that most people, almost everybody in fact, did not care whether or not I drank at their parties. Some people don’t even notice. I just said: “I’m off the drink.” People just said: “Cool.” On planes I was happy not to drink the little bottles of wine. I did not drink low-alcohol drinks. I did not have little nips of this or that. I knew I was not going to drink, and this knowledge made me not want to drink. I felt in control. I knew I would drink again on my birthday. I had a persistent fantasy that, the next time I started to drink, things would be better.

They never were. I could never drink in moderation. I could never have just the one, or just a couple. I always wanted more. I was never quite in control of the amount I drank, as if my brain had been damaged. Something felt wrong, and this feeling of wrongness would get worse as the year wore on – summer worse than spring, autumn worse than summer. During the times when I drank, I had another persistent fantasy, which would pop into my mind every so often: a big, fat, round tumbler of super-strength vodka, shimmering under a layer of ice, so strong it smelled like petrol. The perfect drink. That was my fantasy when I drank, and it was still my fantasy on the day I slugged my last drink, some kind of fruit punch, in the early hours of 1 January 2013. In just 120 days, I thought, that big fat vodka will be there, in some fancy minimalist bar, waiting for me.

In the five years since that moment, I have not touched a drink, and I have not wanted to. My drinking days seem far away, almost like a life lived by somebody else. Drink – the very idea of it – seems rather sickening. Quaffing sour or pungent liquids in order to make yourself dumber? Preposterous! I have the same feelings about alcohol that I had when I was 10. It’s dangerous; it’s disgusting; it causes cancer; it rots your liver and makes you look, and smell, like a much older and sicker person. Still, I’ve never stopped wondering why it grasped me so firmly, and for so long, why I allowed it to ruin parts of my life, parts I will never get back. What did drink offer me that was so much better than sobriety? What, exactly, was its magic?

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Which leads to fines in the millions of dollars per intrusion

The onus of being knowledgeable about FDA regulations thus rests on firms that design and market software.

Developments in the area of medical device software –i.e., the software that is put to use in medical devices –have been taking place at such a torrid pace that regulatory agencies such as the FDA have been unable to keep pace with them. Almost invariably, every development in medical device software brings about a new level of complexity.

Also, the classification of the device is another factor the FDA and other regulatory agencies have had to contend with: Different regulations have to be made depending on whether the software in medical devices is to be classified as a device itself, is used to alter the performance of the device, or is used for computing values. The inability of the regulatory agencies to catch up with the speed of developments in the medical device software arena has had the agency scurrying for quick solutions.

Among these are its decision to integrate the current provisions of voluntary standards developed by the National Institute of Standards and Technology (NIST), which it considers as a useful guidance for medical software professionals and voluntary information sharing organizations to meet cybersecurity challenges into its regulatory oversight. The onus of being knowledgeable about FDA regulations thus rests on firms that design and market software.

Learning on all the aspects of medical device cybersecurity

A formal learning session that examines this complex relationship is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. The speaker at this webinar is Casper Uldriks, ex-FDA Expert and former Associate, Center Director of CDRH. Participants who wish to gain clarity on these aspects of medical device cybersecurity can register for this webinar by visiting National Institute of Standards and Technology

The speaker at this webinar will seek to help participants identify the FDA’s fundamental premarket and postmarket requirements that involve software. When medical device companies go to the FDA for approval to market their product; they need to be very well informed about everything that the FDA states and requires in this regard, because, as we have examined, the burden of design factors requires well informed considerations about how medical device manufacturers protect their product’s software and how they outsmart increasingly sophisticated cyber attackers.

All-round plans

At the same time, device manufacturers also need to be totally compliant with the regulatory options and responsibilities lie with them when a cybersecurity problem is located in their device. Their responsibilities include plans about how to recover and publicly disclose cyberattacks, especially when private medical records are involved. Not getting this right leads to fines that run into millions of dollars for every breach.

So, their cybersecurity efforts should be inclusive of important factors such as these among others:

o  Design planning

o  Postmarket vigilance

o  Training for employees

o  An action plan for managing an attack.

Learning on the factors to consider

Casper will help participants identify these basic considerations at this webinar. He will explain the kind of device cybersecurity programs that protect and foster the performance of device based software or standalone software that device manufacturers need to instill in order to assure the safe use of the device. Such programs need to use the FDA’s premarket and postmarket information requirements when entering and staying in the market.

This session is of very high value to professionals who deal with some or another form of medical device software and its marketing. This includes those in Regulatory Affairs, Quality Assurance, Software Design Engineers, Manufacturing, the Complaint Department, Hospital Risk Department, and those who market their own labels.

Casper will cover the following areas at this webinar:

o  FDA’s Cybersecurity Premarket Design Information

o  FDA’s Postmarket Controls

o  Voluntary Controls

o  Cybersecurity Training

o  Recovery Plans.

Understanding and applying ICH Q3A and Q3B

The ICH guidelines Q3A and Q3B deal with the ways of addressing organic and anorganic substances, respectively.

The ICH Q3A and Q3B are guidances on dealing with impurities in new drug products. These documents have been issued by the FDA and are updates of earlier versions on the same topic that were prepared by the ICH, which this FDA guideline complements. This is why the documents get their name. The FDA keeps revising these documents from time to time. After every revision, the latest version carries the added taxonomy of “R” to denote that the guidance is a revised one.

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The Q3A and the Q3B are two revised guidelines that relate to impurities in drugs. Impurities can happen due to a number of reasons. These are some of them:

  • Raw materials
  • Byproducts
  • Residual solvents
  • Reagents
  • Product reactions
  • Catalysts
  • Foreign impurities
  • Product degradation

The ICH guidelines Q3A and Q3B deal with the ways of addressing organic and anorganic substances, respectively.  They both follow the principles of reporting, identification and qualification of impurities at defined limits. They both exclude impurities arising out of the excipients of drug products.

Scope of Q3A

The scope of the Q3A guideline is limited to testing of impurities in new drug substances. It concerns itself with the content and qualification of chemical substances in new drugs. It is not meant for products derived from herbal, crude, animal or plant, or semi synthetic origin. It is also not for products in the clinical trial stage or for addressing extraneous contaminants, polymorphic forms or enantiomeric impurities.

Scope of Q3B

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The scope of the Q3B guideline differs in some ways from that of Q3A. It is meant for the content or qualification of degradation products. It excludes products of all the sources that Q3A does, and additionally also excludes impurities arising from excipients or extractables/leachables of the container closure system.

Thorough and full understanding of these guidelines

It is to offer a complete and thorough knowledge of how to apply the Q3A and Q3B guidelines that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar. Greg Martin, who is the President of Complectors Consulting (www.complectors.com), which provides consulting and training in the area of Pharmaceutical Analytical Chemistry and served as Director of Pharmaceutical Analytical Chemistry (R&D) for a major Pharma company for a number of years during his over 25 years of experience in the pharmaceutical industry; will be the speaker at this webinar.

To gain clear insights into how these ICH/FDA guidelines apply to your laboratory or area of work, please register for this webinar by visiting Applying ICH Q3A and Q3B for Control

All about the guidelines and regulatory expectations

The objective of this webinar is to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants, including DNA reactive/potential genotoxic impurities, in drug substances and drug products.

Participants who complete this course will be able to:

  • Understand regulatory expectations regarding impurities, degradants and potential genotoxic impurities in pharmaceuticals
  • Understand what specifications will conform to regulatory expectations
  • Develop a process for reporting impurities and addressing OOS situations

Greg will cover the following areas at this webinar:

  • Landscape of impurities requiring control in pharmaceutical products
    • General impurities: elemental impurities, residual solvents, microbiological
    • Drug-related impurities process impurities, degradants, potentially genotoxic impurities
  • Process Impurities
    • Understanding ICH Q3A
    • Where impurities originate
    • How impurities are characterized
    • How specifications are developed
    • How impurities should be reported
  • Degradants
    • Understanding ICH Q3B
    • Where degradants originate
    • How degradants are characterized
      • Potential genotoxic impurities
    • How specifications are developed
    • How degradants should be reported
  • Questions and discussion