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FDA Inspections - Do's and Don'ts 2019

Ref: 28701 Friday March 22nd, 2019 - Online

Overview: In this webinar speaker will define the steps necessary to prepare for an FDA inspection and discuss details surrounding the management of inspections from announcement to close out meeting.   Why should you Attend: This session will discuss how to prepare for the ...

Education: Pharmacy, Medicine, Bio-Technologies, Public Health

Secrets to Writing Effective SOPs for Medical Device QMS

Ref: 29065 Monday March 25th, 2019 - Online

Overview Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is ...

Education: Pharmacy, Medicine, Bio-Technologies

Compliance with the New ICH GCP Revision 2 Addendum

Ref: 29031 Monday April 01st, 2019 - Online

Overview: This will enable you to meet the new international GCP standard to ensure regulatory compliance and the acceptance of clinical trial data by the regulatory authorities internationally.   Why should you Attend: With the new ICH GCP E6 Revision 2 Addendum now finalised ...

Education: Medicine, Bio-Technologies, Toxicology, Public Health

Understanding and Implementing a Technology Transfer Process

Ref: 29032 Monday April 01st, 2019 - Online

Overview: Identify elements of the business process framework for managing    technology transfers. Explain benefits of technology transfer.    Determine elements of a successful technology transfer.   Why should you Attend: This presentation will ...

Education: Medicine, Bio-Technologies, Public Health, Pharmacy

Audit Trail Generation and Review 2019

Ref: 29033 Wednesday April 03rd, 2019 - Online

Overview: These electronic records must be maintained according to regulatory    requirements contained within FDA's 21 CFR Part 11 for US    jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions.   Why should you Attend: Attendees will learn ...

Education: Medicine, Bio-Technologies, Public Health, Pharmacy

Supply Chain Traceability is Going Digital [What You Can Do to Prepare]

Ref: 29034 Wednesday April 03rd, 2019 - Online

Overview: Recall requires traceability data that tells what food is in the stream,    where it is located and recall systems must be able to provide such    information in real time. Reducing recall time means reducing    illness, the loss of life and ...

Education: Medicine, Bio-Technologies, Computer science, Public Health, Pharmacy

Test Method Validation to Verify the Performance of a Medical Device

Ref: 29035 Thursday April 04th, 2019 - Online

Overview: Those who work with process optimization and validation focus on    optimizing a process and reducing variability. Those working on Test    Method Validation, on the other hand, focus on discerning between    process variation and measurement ...

Education: Medicine, Bio-Technologies, Computer science, Public Health

Best Mastering Excel Formulas and Functions 2019

Ref: 29036 Monday April 08th, 2019 - Online

Overview: Functions are built-in formulas that have been programmed to    perform a specific calculation. They range from the simple such as    SUM and AVERAGE (used to calculate the total and average of    numbers in a range of cells) to the powerful ...

Education: Medicine, Bio-Technologies, Computer science, Public Health

FDA's New Import Program for 2019

Ref: 29037 Tuesday April 09th, 2019 - Online

Overview: In this interactive session author will discuss about the FDA's    required information for the PREDICT software screening prior to    entry and Custom's Harmonized Tariff Schedule (HTS).   Why should you Attend: The new import entry filing ...

Education: Pharmacy, Medicine, Bio-Technologies, Public Health, Computer science

Strategies To Prevent Manufacture And Distribution Of Substandard Medications

Ref: 29038 Wednesday April 10th, 2019 - Online

Overview: In this webinar we will provide you with best practices that have    been proven effective, and equip you with the means to advocate for    these ideas within your organization.   Why should you Attend: If a legitimate product is not manufactured ...

Education: Medicine, Bio-Technologies, Public Health, Pharmacy

Data Integrity: Compliance with 21 CFR Part 11

Ref: 29039 Thursday April 11th, 2019 - Online

Overview: This webinar describes exactly what is required for compliance with    Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud    hosted applications.   Areas Covered in the Session: What 21 CFR Part 11 means today Purpose of Part ...

Education: Pharmacy, Medicine, Bio-Technologies, Computer science, Public Health

How to Implement MDSAP-Requirements into your ISO 13485

Ref: 29040 Monday April 15th, 2019 - Online

Overview: How a smart implementation of these requirements in the quality    management system is possible and finally how the audit for five    countries (Australia, Brazil, Canada, Japan, US) is working.   Why should you Attend: Your implementation time ...

Education: Medicine, Bio-Technologies, Toxicology, Public Health, Pharmacy

Controlled Document System for a Life Sciences Manufacturing Plant

Ref: 29041 Thursday April 18th, 2019 - Online

Overview: Life science manufacturing plants have the additional responsibility    to ensure that each and every step of the manufacturing process is    controlled by work instructions, SOPs, set-up instructions, equipment    maintenance, and support ...

Education: Pharmacy, Medicine, Bio-Technologies, Public Health

Turn a Culture of Quality Into a Competitive Advantage

Ref: 29042 Tuesday April 23rd, 2019 - Online

Overview: A culture of quality is a powerful tool for creating an effective and    efficient Quality Management System. A culture of quality is not    accidental but can be purposefully nurtured and developed.   Why should you Attend: Every organization ...

Education: Medicine, Bio-Technologies, Public Health, Toxicology

Quality Risk Management Overview 2019

Ref: 29275 Thursday May 02nd, 2019 - Online

Overview: Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM. Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions.   Why should you Attend: It can ...

Education: Medicine, Bio-Technologies, Toxicology, Public Health

Quality Control for Microbiological Media and Reagents

Ref: 29276 Friday May 03rd, 2019 - Online

Overview: This webinar will help you develop a quality control program that fits your microbiological laboratory's needs. We will explicitly not cover any serological, immunological or molecular tests.   Why should you Attend: In microbiology laboratories, there are a wide array and ...

Education: Pharmacy, Medicine, Bio-Technologies, Toxicology, Public Health

Statistical Hypothesis Tests: Concepts and Applications

Ref: 29277 Tuesday May 07th, 2019 - Online

Overview: This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes.   Why should you Attend: This webinar will lay the ...

Education: Medicine, Bio-Technologies, Public Health, Pharmacy

Architect and Implement Solution 2019

Ref: 29279 Tuesday May 07th, 2019 - Online

Overview: We will cover how to identify, analyze and document the events and environmental surroundings that can adversely affect the organization.   Why should you Attend: The FFIEC is a wonderful guideline that banks are supposed to follow, but the interpretation of the guideline ...

Education: Medicine, Bio-Technologies, Toxicology, Public Health

How to Create a Medical Software Development File - ISO 62304

Ref: 29280 Monday May 13th, 2019 - Online

Overview: You will learn, how to apply the ISO 62304 in the medical software development process and how to create a medical software development file.   Why should you Attend: You should attend this webinar to understand, what is the ISO 62304 for medical software and how is the ISO ...

Education: Pharmacy, Medicine, Bio-Technologies, Management, Public Health, Toxicology

FDA's Quality Metrics - Latest Advances

Ref: 29281 Friday May 24th, 2019 - Online

Overview: This is a very important webinar for the FDA who is planning to use the quality metrics as part of their risk based inspection process.   Why should you Attend: This is a very important initiative for the FDA who is planning to use the quality metrics as part of their risk ...

Education: Pharmacy, Medicine, Bio-Technologies, Public Health, Toxicology

How to conduct a Compliance Gap Analysis for ERM

Ref: 29282 Friday May 24th, 2019 - Online

Overview: This webinar will explain how to conduct a compliance gap analysis for Enterprise Risk Management (ERM). Attendees will learn best practices to ensure ERM compliance.   Why should you Attend: Many companies today are "short staffed" and may skip vital steps that are ...

Education: Pharmacy, Medicine, Bio-Technologies, Public Health

Overcoming Obstacles of the Canadian Drug Regulatory Landscape

Ref: 29283 Tuesday May 28th, 2019 - Online

Overview: Through this presentation, you will develop a comprehensive understanding of the Drug Approval Process and in parallel examine major misconceptions and misunderstandings.   Why should you Attend: We will share insights and practical examples that facilitate a positive, ...

Education: Medicine, Bio-Technologies, Management, Public Health, Pharmacy