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What do you know about impurities?

What do you know about impurities?

2022-08-16

In this blog, impurities are explained in depth on the pharmaceutical approach.

NEVER KNEW ABOUT CELL BANKING & TESTING

NEVER KNEW ABOUT CELL BANKING & TESTING

2022-08-16

In our previous blog, we gave you a clear idea of what is a cell, how it functions, and the purpose behind it. In this blog we are will be sharing something that is interesting about cell banking and testing. 

What you should Know About GAMP

What you should Know About GAMP

2022-08-16

With the gradual increase of these Systems, many manufacturing companies took this as an advantage to dwell into the field of pharma manufacturing. As a result, a need raised to come up with a foolproof and risk-free system.

 

What do you know about ICH E8 (R2) Guidelines

What do you know about ICH E8 (R2) Guidelines

2022-08-16

When ICH initiated the guidelines on Clinical studies and Clinical Trials, a set of principles and practices were laid out to ensure that the design and structure of conducting clinical trials.

The Prominent Features of CRO Oversight

The Prominent Features of CRO Oversight

2022-08-16

Sponsors are under additional pressure to increase efficiency while preserving quality as a result of clinical studies becoming more complex as more data is collected.

Efficacy of Quality Control For Biologics and ATMPs

Efficacy of Quality Control For Biologics and ATMPs

2022-08-09

Characterization and analysis of advanced therapy medical products (ATMPs) are crucial for delivering the crucial chemistry, manufacturing, and control (CMC) data required for submission in investigational new drug applications.

The Impact of Cell Bank Establishment

The Impact of Cell Bank Establishment

2022-08-03

For products made from cells, cell bank characterization is a crucial quality-control procedure. A well-established cell bank is essential to guarantee there is an appropriate supply of similar cells for use for the course of the product's complete life span once a cell line is selected as its biological source. 

The Effects Of Changing Restrictions On Pediatric Drug Development

The Effects Of Changing Restrictions On Pediatric Drug Development

2022-07-25

Children should receive medications that are customized for them. Over the past few decades, there has been a growing awareness of the necessity of involving children in the drug development process.

Managing Strategic Accounts in the Pharmaceutical Industry

Managing Strategic Accounts in the Pharmaceutical Industry

2022-07-19

Key Account Management (KAM) in the Medical Sector, Prescription authority has recently been divided across organizations, committees, or networks of medical, social, administrative, payer, and patient representatives.

Benefits, Challenges, and Future Potential of Pharmacovigilance

Benefits, Challenges, and Future Potential of Pharmacovigilance

2022-07-11

The evaluation of spontaneous reports are obtained when it is carried out within the strict and well-defined good pharmacovigilance procedure framework,

The effectiveness of Clinical Project Management

The effectiveness of Clinical Project Management

2022-06-08

Setting milestones, risk management, allocating employees and money, and dealing with clients and contracts are all examples of clinical project management.

Vaccine Development & Testing

Vaccine Development & Testing

2022-05-31

Vaccines are one of the most significant advances in public health, and finding new vaccines continues to be one of the most difficult tasks we face.

Viral Clearance Methodologies

Viral Clearance Methodologies

2022-04-12

Chemical contaminants, bacteria and fungi, and viruses all pose threats to biological and biotechnological goods. Transmission of viral infections is a genuine possibility with these items.

Product Stability Testing in Biologics

Product Stability Testing in Biologics

2022-03-16

Stability testing is an important aspect of product development and is carried out throughout the life cycle of a product. Stability is part of a biotherapeutic's quality desired product profile, and the results help analysts understand how temperature, relative humidity (RH), light, storage, pH, and other factors affect critical quality attributes (CQAs) of both medicinal ingredients and products.

Benefits of Agile Auditing

Benefits of Agile Auditing

2022-03-02

Internal audits are a necessary for any organization that wishes to last a long time, be successful, and have a good reputation. Internal auditing provides management with a wealth of valuable information by providing an independent and objective review of corporate activities, allowing for unbiased and informed decision-making.

Why is corporate governance important?

Why is corporate governance important?

2022-02-16

Imagine a company in which everyone can do what they like… no rules, no supervision. Wouldn’t that be a chaos? Corporate governance is important because it encompasses the set of principles, the rules by which all employees should act (policies and procedures, responsibilities by each job position, etc.).

How to Choose a Best Pediatrician

How to Choose a Best Pediatrician

2022-02-10

Choosing a pediatrician is one of the most important and challenging decisions you'll make about your child's health. Whether your child has already entered the world or is due any time soon. A pediatrician is a doctor who focuses on children's physical, behavioral, and mental health.

The Advantages of In-house Training

The Advantages of In-house Training

2022-01-12

In-house training is a sort of corporate training in which a company's own skills and assets are used. This is a training that the learning for employees led by the company itself. Internal employees and workers are responsible for employee training.

Quality Risk Management (QRM) in Pharmaceutical Industry

Quality Risk Management (QRM) in Pharmaceutical Industry

2022-01-06

Quality Risk Management (QRM) is the process of identifying, evaluating, and mitigating recognized risks connected with medicines and healthcare goods. An excellent Quality Risk Management programme can be created to reduce risk to a manageable level and deliver high-quality products to protect citizens' health.

Learn how to Draft Quality Contracts

Learn how to Draft Quality Contracts

2021-12-15

A contract is one of the most important components of any industry or corporation, and conducting business or engaging in any form of collaboration without one may be a nightmare for all parties involved.

Benefits of Virtual Team Building

Benefits of Virtual Team Building

2021-12-08

Nowadays so many firms transitioning to entirely remote work, it's more critical than ever to engage and create a sense of belonging within your team. Nowadays so many firms transitioning to entirely remote work, it's more critical than ever to engage and create a sense of belonging within your team.

Basel 4 : What you need to know?

Basel 4 : What you need to know?

2021-11-24

When it comes access to funding, Basel 4 will be a game-changer for both banks and corporations. The legislation, which is the finalization of Basel 3 and will take effect in 2023, would reform global bank capital requirements, affecting corporate lending in Europe and the Nordics in particular.

Development of LC/MS for Regulated Bioanalysis

Development of LC/MS for Regulated Bioanalysis

2021-11-17

The rapid development of Liquid Chromatography/Mass Spectrometry (LC/MS) technology changed the way bioanalysis was done. Regulated Bioanalysis services are valuable to both the clinical and preclinical phases of studies.

Connecting everyone with Risks

Connecting everyone with Risks

2021-11-08

Have you ever wondered how to connect everyone with risks? How to capture the attention of the Board to this important issue?

Internal Auditing : A Brief Overview

Internal Auditing : A Brief Overview

2021-10-19

Internal Auditing in the sense independent assurance and consulting activity performed to add great value and improve an organization’s operations.

Pharmacovigilance Audits & Types of PV Audits

Pharmacovigilance Audits & Types of PV Audits

2021-10-13

The audit in the sense a systematic and independent examination of activities to identify whether the evaluated activities were performed according to decided requirements.

An HR's guide to Cybersecurity in 2022

An HR's guide to Cybersecurity in 2022

2021-10-06

Cyber security is the practice of protecting mobile devices, laptops, servers, computers, networks, electronic systems, etc. from malicious attacks. Understand What is Cybersecurity and Why Cybersecurity Training important for employees.

Let’s Tackle Fraud Risk!

Let’s Tackle Fraud Risk!

2021-07-01

How would you know if your company is protected from fraud? If you don’t know, let’s tackle fraud risk!

Which areas of your company do you audit?

Which areas of your company do you audit?

2021-05-01

From auditor to auditor: which areas of your company do you audit? The most common answers I’ve heard are two: a) the accounts that are related to money such as banks, petty cash, payments, purchases, etc. and b) the accounts that have a higher balance because when auditing them, a higher amount is being covered.

Reviewing salaries, Fairly

Reviewing salaries, Fairly

2021-03-02

The simple increase in an employee’s salary is a delicate process called the salary (or pay) review. Salary reviews are usually conducted annually. It is a process whereby employers determine if the employees’ salaries are fair as well as ensuring that salaries are reflecting what the market is offering for similar positions.

Due diligence in FinTech, Do you know what to check?

Due diligence in FinTech, Do you know what to check?

2021-03-02

Chime, Coinbase, IZettle, MetroBank, Barion all are fintech companies…if carry out due diligence, do you know what to check?

Put it right in writing!

Put it right in writing!

2021-01-01

The audit has finished. Now is time to put it right in writing. And for some reason, although this step is the most important -in most cases-, auditors fail to do it right. The top mistakes detected:

How exposed is your company to climate risk?

How exposed is your company to climate risk?

2020-12-01

Sea level rises, air, water and land pollution, deforestation, resource scarcity…how exposed is your company to climate risk? These factors are affecting any country’s economic activity.

How to manage the Employees’ Performance?

How to manage the Employees’ Performance?

2020-11-01

Have you ever wondered how to manage the employees’ performance? What should it be measured and how?

Don’t let them Burnout!

Don’t let them Burnout!

2020-09-01

Have you thought about the mental health of your employees? Don’t let them burnout! It’s a fact: most highly engaged employees are exhausted. If this has happened in a normal environment take a moment to think how much this has increased with COVID-19.

Pay Strategy: Relevance and Effectiveness

Pay Strategy: Relevance and Effectiveness

2020-08-01

For a pay strategy to be effective, it must be integrated with the company’s overall business strategy. Achieving this integration can be difficult. This is because a business strategy can be hard to specify. 

The Importance of Coaching

The Importance of Coaching

2020-08-01

Have you ever wonder about the importance of coaching? No, don’t think about sports; think about coaching in business.

Are you sure your risk-based approach is effective?

Are you sure your risk-based approach is effective?

2020-07-01

Let’s see: are you sure that your risk-based approach is effective? If you haven’t updated it during the year…if only the Internal Audit talks about risks…or if the budget is not related to it…well, it’s clear: the risk-based approach is not effective.

The on demand talent

The on demand talent

2020-06-01

Which is the on-demand talent that companies need? Coronavirus has also changed the skills we need to work. Here are some...

On the Corona Crisis (… of course, what else) – Part 1

On the Corona Crisis (… of course, what else) – Part 1

2020-04-02

Originally I was going to write about sustainability concerning employee treatment. But I will save the topic for later because the events of the last couple of weeks are asking for something more up to date. The situation about the coronavirus pandemic has got many connections to the workplace health and safety and to the way we manage it.

On the Corona Crisis (… of course, what else) – Part 2

On the Corona Crisis (… of course, what else) – Part 2

2020-04-02

Presumed impact of collective experience Thread on safety culture at the workplaces

The importance of a happy work environment

The importance of a happy work environment

2020-04-01

Having a happy work environment brings many benefits, among them: creativity and innovation increases, as well as productivity, employees are more engaged and your company is more successful. But, how to do it?

Impact of agile workplace design on employee productivity

Impact of agile workplace design on employee productivity

2020-03-02

In today’s time, it seems job-hopping is a more popular trend than good old loyalty and career ladder climbing within the same organization.

Risks in 2022

Risks in 2022

2020-03-02

If risks were considered a key part for internal auditors, in 2022 risks are a must. Audits should be risk-based and agile, responding to emerging risks. For this year, top risks include:

Generate value to the company: Minimize Behavioral Risk

Generate value to the company: Minimize Behavioral Risk

2020-02-02

Have you heard about behavioral risk? Do you know how it can generate value to the company? Even now regulators are paying attention to it.

Building and Sustaining a High-Performance Culture by design in the Virtual World

Building and Sustaining a High-Performance Culture by design in the Virtual World

2020-01-01

If culture eats strategy across all three meals, then the CEO serves those meals.

The Audit skills needed for 2022

The Audit skills needed for 2022

2019-12-01

The world is changing, thus the environment, way to do things, the companies. It’s essential to speak about the audit skills needed for 2022; either the ones you need to update or improve.

Safety in workplace and personal values

Safety in workplace and personal values

2019-12-01

Strengthening the corporate culture to make safety a priority value. Employee involvement. Safety motivation. Issues that are being discussed quite often these days.

Whom are you going to trust your money?

Whom are you going to trust your money?

2019-11-01

Is not about the services a bank offers… Neither it’s app. Is about whom are you going to trust your money; and this is linked to the bank’s quality service.

Challenges Women Leaders Face in Professional World

Challenges Women Leaders Face in Professional World

2019-08-01

“A woman with a voice is by definition a strong woman. But the search to find that voice can be remarkably difficult. This “voice” is your best tool in the boardroom.” 
Melinda Gates, Co-founder of Bill & Melinda Gates Foundation

 

The Millennial Woman in Leadership

The Millennial Woman in Leadership

2019-07-01

‘Women leaders’ and ‘millennials’ are two words which are resonating in our minds.

The Female Competencies

The Female Competencies

2019-04-01

Do you know which are the female competencies needed to be a leader? Let’s talk about those essentials that you should have:

Fraud Prevention and Detection

Fraud Prevention and Detection

2019-03-01

How to do it? Here are some tips to improve fraud prevention and detection:

Empowering Women

Empowering Women

2019-02-01

Have you heard of the concept of empowering women?

How to become a Leader

How to become a Leader

2019-01-01

Have you ever wondered how to become a leader? If so, this information is for you.

Robot Safety Rocks! After Prague 2019

Robot Safety Rocks! After Prague 2019

John Kersey writes on safety technology and related topics for the SHP online publication. He was one of the presenters at the European HSE Forum 4.0 conference in Prague in September 2019 He was acknowledged as one of the Top 5 Speakers at the conference. His presentation covered 5 top safety trends to be aware of. Here he reflects on takeaways since the conference.





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Process Validation for Biotechnological Products - EU edition MasterClass

Process Validation for Biotechnological Products - EU edition MasterClass

07-08 February, 2023

This MasterClass will provide best understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production.

Good Clinical Practices - US edition MasterClass

Good Clinical Practices - US edition MasterClass

07-08 February, 2023

This online practical course provides an in-depth understanding of GCP requirements and their practical implications.

Pharma Good Distribution Practice - EU edition MasterClass

Pharma Good Distribution Practice - EU edition MasterClass

09-10 February, 2023

This informative training with two RP’s / RPI’s for all things GDP.

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