Change management system should be structured according to the firms Pharmaceutical Quality System (PQS) and should be based on ICH Q8, ICH Q9, and ICH Q10.
The change management system should also be designed to cover all aspects of all products and processes utilized at the facility. Thus, any proposed change should undergo a clear and logical evaluation to assure that implemented an item do not affect the current state of control.
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.
Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?
Attend this webinar to help your organization most successfully avoid mistakes in HMDA reporting. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/Tools-and-Techniques-to-Avoid-HMDA-Reporting-Mistakes-503292/NOVEMBER-2018-ES-TRAININGREGISTRY
Attain an understanding of the General Data Protection Regulation (GDPR). Be able to understand the key of the main tenets of GDPR which impact on clinical trials. Consider data breaches. Understand the role of the Data Protection Officer (DPO). Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/EU-General-Data-Protection-Regulation-GDPR-Compliance-for-Drug-development-and-Clinical-Trials-504942/NOVEMBER-2018-ES-TRAININGREGISTRY
This webinar will help you ensure an efficient and effective CAPA process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA this webinar is for you.
Clinical trials' data gives an accurate representation of what we measure to evaluate effects of the treatments under comparison. The clinical data recording process, however, as inspected/audited by inspectors/auditors is initiated with the recorded data, either in the Case Report Form, or in some other system, or in an electronic database.
From there, the data subjected to the process of data management is repeatedly inspected to ensure that the data that finally appear in the report are identical to the original, i.e. nothing untoward has happened on the way.
This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements.
Why should you Attend: The lack of or inadequate standard operating procedures (SOPs) continue to dominate the FDA's and other regulatory inspector's inspection observations. This is often caused by poor writing and management and control of SOPs. SOPs need to be easily understood by all those who have to follow them. Well written and effective SOPs are not only a regulatory requirements, they also make good business sense. Too often employees fail to follow SOPs because they can't understand them, and too many times we've seen procedures being constantly revised.
Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. As scientific advances continue, the types of therapies being developed have higher potency and novel targets; and increased pressure to have study designs that speed up clinical development.
In 2016, the ICH revised the E6 guidelines to further standardize processes in biomedical products development, decrease redundancies; and reflect the current research landscape such as increases in globalization, study complexity, and technological capabilities.
This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:
How to link risk with the confidence statements associated with the sampling plans
Identify a variety of sampling plans, that all make the desired confidence statements
Select from among these sampling plans that plan which offers the best balance between the number of units tested and the risk of failing the validation
How to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates
FinCEN has promulgated new rule for customer due diligence that is encouraging, in a very official way, to go beyond the check box mentality that has really plagued all KYC since the first Patriot Act was passed.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/New-Customer-Due-Diligence-Rules-Are-you-Ready-508757/SEPTEMBER-2018-ES-TRAININGREGISTRY
This presentation will discuss key compliance issues with respect to medical director contracts. More specifically, it will discuss the regulatory framework governing medical director contracts, key compliance issues, how to audit for medical director contract compliance, and recent government enforcement trends relating to medical director agreements.Price:$160.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/Medical-Director-Contracting-Key-Pitfalls-to-Avoid-506752/SEPTEMBER-2018-ES-TRAININGREGISTRY
This webinar will explain what money laundering is, various types of money laundering including structuring, micro-structuring and cuckoo smurfing. Attendees will learn how to identify the red flags of money laundering in an account within your institution. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/Red-Flags-of-Money-Laundering-509031/SEPTEMBER-2018-ES-TRAININGREGISTRY
Join us for a study of best practices guidelines for payroll tax compliance. Learn the processes, controls and procedures to follow and keep your tax obligations paid on a timely basis. Learn the process for setting up new hires properly. Identify the steps to ensure all workers are properly classified as either employees or independent contractors and employees are properly classified as either FLSA exempt or nonexempt.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/Payroll-Legislative-Update-509757/SEPTEMBER-2018-ES-TRAININGREGISTRY
By attending this session you will be able to ensure that you understand the compliance issues directly related to the practice of case management and that you have incorporated them into your daily practice. Compliance includes documentation and communication with the patient and family as well. Be sure that your processes are hard-wired and part of your daily routine.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/Compliance-Measures-for-Case-Managers-508519/SEPTEMBER-2018-ES-TRAININGREGISTRY
This course is designed to provide CPAs who perform financial statement preparation, compilation or review engagements with the most current best practices and identify practice pitfalls. In addition, the course will cover the new SSARS No. 24. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/2018-Financial-Statement-Preparation-Compilation-and-Review-506594/SEPTEMBER-2018-ES-TRAININGREGISTRY
This course will discuss procedures and processes your BSA department can employ when your institution is clearing and disposing alerts for potential hits identified by your screening process related to companies, individuals, and countries identified by government, international, internal, and other lists as sanctioned or of concern for money laundering, terrorist financing or other criminal activity. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/Your-Sanctions-Program-and-How-to-Clear-True-Hits-and-False-Positives-509977/SEPTEMBER-2018-ES-TRAININGREGISTRY
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/Human-Error-Prevention-in-Pharmaceutical-Manufacturing-503932/SEPTEMBER-2018-ES-TRAININGREGISTRY
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.
To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in CGMP for US FDA regulated industry. Data integrity and security infractions are not only 21 CFR Part 11 issues but also severe CGMP violations.
This 60-min webinar will familiarize participants with USP Chapter 1029 on good documentation guidelines, And This session will wrap up the general concept and will provide information as to what needs to be documented in certain records, Finally, you will know what kind of information to include in the most popular records dealt with in the manufacturing environment.