Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704531

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.

11 / Jul / 2024 - Thursday

* Per Attendee $299

 

US FDA Requirements for Medical Products Labeling / UDI

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706969

The U.S. FDA has several requirement for the labeling of medical products. The key requirements are in 21 CFR 801.

15 / Jul / 2024 - Monday

* Per Attendee $199

 

Gaining and Re-establishing Control of Your Cleanroom

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705317

This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.

15 / Jul / 2024 - Monday

* Per Attendee $199

 

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

webinar-speaker   David Nettleton

webinar-time   90 Min

Product Id: 701687

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

6 / Aug / 2024 - Tuesday

* Per Attendee $249

 

The 510(k) Mod Program, Breakthrough Technologies, and STeP

webinar-speaker   John E Lincoln

webinar-time   90 min

Product Id: 706976

What are the U.S. FDA's recently expanded, less traditional / modified pathways for novel technologies or safer products to receive clearand or approval.

7 / Aug / 2024 - Wednesday

* Per Attendee $199

 

Process Validation Requirements & Compliance Strategies

webinar-speaker   Jose Mora

webinar-time   60 Min

Product Id: 700162

This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process.

14 / Aug / 2024 - Wednesday

* Per Attendee $199

 

Dietary Supplements' CGMPs, 21 CFR 111

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706360

What are the U.S. FDA's requirements for marketing and selling dietary supplements / nutraceuticals in the US, including their QMS per 21 CFR 111.

27 / Aug / 2024 - Tuesday

* Per Attendee $199

 

Decision-Making and Human Error Prevention

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 706986

Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention." In today's complex and fast-paced world, the ability to make sound decisions and minimize the risk of human error is crucial across various professional domains.

28 / Aug / 2024 - Wednesday

* Per Attendee $199

 

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

webinar-speaker   David Nettleton

webinar-time   75 Min

Product Id: 701582

Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.

10 / Sep / 2024 - Tuesday

* Per Attendee $229

 

Document the Clinical Evaluation Report (CER) for the EU MDR and CE Mark

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706985

To document the clinical evaluation of a medical device and its output, a Clinical Evaluation Report or CER has to be compiled. The CER is an ongoing compilation of the generation, appraisal, and analysis of clinical data related to a device. It is one of the major components of the Technical Documentation File.

20 / Sep / 2024 - Friday

* Per Attendee $199

 

Acceptance Sampling Plans for Process Validation and Production Lot Monitoring

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 704315

This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.

Recording Available

 

Reconciling/Adapting the 8D Problem Solving Process for the Life Sciences

webinar-speaker   Charles H Paul

webinar-time   90 Min

Product Id: 706939

The 80 problem solving process developed by the Department of Defense and driven by Ford Motor Company is a worldwide method used to improve quality address customer complaints and issues quickly and efficiently. The process helps develop rapid response to customer issues and complaints and strengthens business relationship with those customers and regulatory bodies. The process helps improve quality and supports and promotes prevention rather than simply the detection of problems.

Recording Available

 

Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production FDA & ICH Expectations and Guidance

webinar-speaker   Barry A Friedman

webinar-time   90 Min

Product Id: 706884

The objective of this interactive, live training webinar is to explore the management of OOS practices and suggested avenues to take to minimize deviations, OOT, OOS and CAPA and how to attack these situations should they occur. It is also designed to determine how FDA and ICH regulations and guidances may impact them. It will also reference the new PDA TR 88, “Microbial Data Deviation Investigations in the Pharmaceutical Industry”.

Recording Available

* Per Attendee $249

 

US FDA's Cybersecurity and NIST Framework Requirementsfor Networks

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706971

Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information, and is a rapidly growing problem for industry. 

Recording Available

* Per Attendee $249

 

Annual Current Good Manufacturing Practices (cGMP) Training

webinar-speaker   Kelly Thomas

webinar-time   60 Min

Product Id: 705422

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

Recording Available

* Per Attendee $249

 

Assess Impact For Supplier Change Notices

webinar-speaker   Alan M Golden

webinar-time   60 Min

Product Id: 706344

This webinar will discuss dealing with supplier change notices. Regulatory agencies have the expectation that a manufacturer has control over its supply chain and dealing with changes to that supply chain can be challenging.

Recording Available

* Per Attendee $249

 

The eSTAR Submission Program for 510(k)s, IDEs, De Novos, PMAs, and Q-Submissions

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706968

The regulation and control of new or substantially changed medical devices for sale in the US is based on the 510(k), PMA or DeNovo submission process; 510(k)s now can only be submitted to the FDA under the eSTAR (electronic Submission Template And Resource) Portal. Other submissions will be phased in using new guidance templates as they become available.

Recording Available

* Per Attendee $249

 

Quality Agreements and Their Role as Part of a Quality System

webinar-speaker   Michael Ferrante

webinar-time   90 Min

Product Id: 706966

This webinar will focus on the Process for Quality Agreements and requirements that must be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn the reason for implementing a Quality Agreement system to assure adequate controls for Service Providers.

Recording Available

* Per Attendee $249

 

P&PC, SPC/6Sigma, Failure Investigation, Root Cause Analysis, PDCA, DMAIC, A3

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706963

This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC) as taught by Drs. Demming and others and required also in the CGMPs and under control of variation process guidance.

Recording Available

* Per Attendee $249

 

Design Control / Ddesign and Development Requirements / Documents Under 21 CFR 820/ ISO 13485 7.3

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706923

Proper adherence and documentation of the FDA's Design Control requirements are key to any medical product project's success.

Recording Available

* Per Attendee $249

 

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