Good Documentation Guideline (Chapter <1029> USP)

  • Speaker:Dr. Afsaneh Motamed Khorasani, PhD
  • Duration:60Min
  • Product Code:GRC-90495

Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. To pay by Check or Wire Transfer please email our support@grcts.com for Invoice. 

Description: 

Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.

This training session will cover the US Pharmacopeia General Chapter <1029> and all aspects of GDP including practices for writing and correcting documentation. 

This 60-min webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

Why you should attend:     

After this webinar, you will become familiar with this USP chapter in good documentation guidelines which adds to all other Good documentation rules and regulations out there. This will wrap up the general concept and will provide the information as to what needs to be documented in certain records. 

Areas Covered in the Webinar Session:

  • History of the chapter as to how and why it was created
  • Purpose of development of this chapter
  • Chapter outline:
  • Principles of Good Documentation
  • Data collection & recording
  • Different types of GMP Documents:
  • Laboratory records
  • Equipment-related documentation
  • Deviations and investigations
  • Batch records
  • Certificate of Analysis (C of A)*
  • Standard Operating Procedure (SOP)*
  • Protocols & reports*
  • Analytical procedures*
  • Training documentation
  • Retention of documents

Who will benefit: 

GDP's are meant for use in the production and control of Active pharmaceutical ingredients (APIs), Medical devices, Excipients, Pharmaceutical products, Labs, Dietary supplements and Food ingredients:

  • Regulatory
  • Compliance
  • Audit
  • Quality
  • R&D
  • Scientists
  • Documentation and Validation
  • Clinical Research
  • Lab Managers
  • Engineering and Manufacturing

Certification: GRCTS Attendance Certificate

Instructor Profile:         

Dr. Afsaneh Motamed Khorasani, PhD is a Medical and scientific Affairs expert and a Senior Scientist with a strong background in biomedical science and clinical trial/research. She has a tenured and diverse range of experience in medical affairs, basic and industrial clinical research and development, clinical trials, Medical and regulatory writing and intellectual property. She is currently the Vice President of Medical Affairs at Easy Global Training, which is a US-based firm providing global regulatory, quality and medical affairs training backed by consulting.

Before joining this company, Dr. Motamed Khorasani has served as an independent consultant, director of medical affairs, senior medical sciences liaison, senior scientist and senior medical analyst at Merck (MDS), Johnson & Johnson, United States Pharmacopeial Convention (USP), Amgen, Baxter International, Covidien (eV3), Radient Pharmaceuticals, AMDL Diagnostics, Microbix Biosystems, Neometrix Consulting, Mount Sinai Hospital, Princess Margaret Hospital, and Vancouver General Hospital.

She has more than 20 years of experience and many National and international certificates in GLP, GMP, ICH-GCP and global regulatory compliance for clinical trials and is a member in a number of professional associations, including: American Association of Cancer Research (AACR), American Medical Writers Association (AMWA), Regulatory Affairs Professional Society (RAPS), American Society of Quality (ASQ), Project Management Institute (PMI), and Intellectual Property Institute of Canada (IPIC).

Dr. Motamed Khorasani's research has focused on high throughput approaches in the context of cancer informatics with a particular interest in the use of comparative analysis for the mining of integrated oncology datasets that include protein-protein interaction and gene expression profiling. She has published and presented more than 50 papers, abstracts and articles in highly regarded scientific journals and high profile conferences and scientific meetings.

Available Options

Recording: 6 Months Access to the Training which can be accessed from any location

$235

CD-DVD: Shipped within 2 working days

$355

USB - Shipped within 2 working days

$365

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$2,675

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$4,685

Recording Access for 12 Months: Participant can access the training Recording for 12 months from any location

$895

Related Products

Writing and Enforcing Effective SOPs

Writing and Enforcing Effective SOPs

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another stor..

$269

Validation and Control of Excel Spreadsheets in Regulated Environments

Validation and Control of Excel Spreadsheets in Regulated Environments

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.  USE COUPON “GRCTS10” TO AVAIL A 10% DISCOUNT Description: Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulatio..

$235

Computer System Validation Requirements

Computer System Validation Requirements

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Certification: GRCTS Attendance CertificateDescription: The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many..

$259

Validation of Analytical Methods according to the New FDA Guidance

Validation of Analytical Methods according to the New FDA Guidance

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.  Description: FDA has released a new comprehensive guidance for validation of analytical methods. The guidance follows the modern integrated life cycle approach with related new requirements for using quality-by-design compone..

$259

Comparing GLP with GMP

Comparing GLP with GMP

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.  Description: Good Laboratory and Good Manufacturing practices are regulations that are applied during different lifecycle phases of drugs and drug substances. Both regulations have some common requirements but there are also si..

$245

Validation and Use of Cloud Computing in FDA Regulated Environments

Validation and Use of Cloud Computing in FDA Regulated Environments

Description:Cloud computing can significantly reduce investment and operating costs for IT operations. However when used in FDA and other regulated environments they need to be validated to ensure consistent on-going performance and security and integrity of stored and managed data. While there are guidelines available on how to deal with standard networks this is not the case for virtual networks and cloud computing, This seminar will give a good understanding of FDA requirements of cloud compu..

$269

FDA's New Enforcement of 21 CFR Part 11

FDA's New Enforcement of 21 CFR Part 11

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. Why should you attend:FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic reco..

$389

FDA's GMP Expectations for Phase I and First-In-Man Clinical Trials

FDA's GMP Expectations for Phase I and First-In-Man Clinical Trials

If you are unable to attend the Live meeting then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. Why you should attend:Attend this conference so that you may understand differences between GMP requirements for early and later stage clinical development.  Explore and discuss ways to develop and implement strategies for your GMP documentation.What is the topic about:This webinar will rev..

$289

Understanding the new Revision of USP 1058: Analytical Instrument Qualification

Understanding the new Revision of USP 1058: Analytical Instrument Qualification

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description:  The first version of USP <1058> has been released in 2008. Since then it has evolved to the global standard for analytical instrument qualification. In August 2017 a new revision has been released with many n..

$269

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Certifications: GRCTS Attendance Certificate -Background:Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful proje..

$259

Writing an Effective Standard Operating Procedure (SOPs)

Writing an Effective Standard Operating Procedure (SOPs)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the Recording of the Training for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Use coupon code "GRCTS10" to avail a 10% Discount on your purchaseCertification: GRCTS Attendance CertificateDescription: Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there is ..

$269