Strategies To Prevent Manufacture And Distribution Of Substandard Medications

webinar-speaker   Michael Esposito

webinar-time   90 Min

Product Id: 706104

Substandard medications, like counterfeit drugs, present a real and increasing danger both to patients and companies. In this webinar, learn how to take a proactive approach to stay ahead of these problems.

6 / Dec / 2021 - Monday

* Per Attendee $229

 

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 703875

This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.

7 / Dec / 2021 - Tuesday

* Per Attendee $249

 

How To Build a Profitable Generic Pipeline Before Your Competition

webinar-speaker   Peter Wittner

webinar-time   90 Min

Product Id: 706766

We all want to have a great generic portfolio, but all our competitors also want the same thing - so how do you make sure that you get the winners to market before they do? Do you go for supergenerics, OTCs, smaller volume niches that you can exploit at higher prices - or should you stick to higher volume staples even though margins might be tight? The webinar looks at product selection and who else in the organisation you need to involve to ensure that you get there on time – is it regulatory? production planning? purchasing? strategic planners? The answer is – all of them!

7 / Dec / 2021 - Tuesday

* Per Attendee $149

 

FDA's Ambitious Regulation of Social Media

webinar-speaker   Casper Uldriks

webinar-time   60 Min

Product Id: 703853

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

7 / Dec / 2021 - Tuesday

* Per Attendee $229

 

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703476

This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.

9 / Dec / 2021 - Thursday

* Per Attendee $229

 

Qualification of Process Analytical Technology (PAT) Based Control Strategies for Batch & Continuous Manufacturing

webinar-speaker   Michael Levin

webinar-time   60 Min

Product Id: 706771

This seminar will provide an insight into the practical aspects of the Process Analytical Technology (PAT) batch and continuous manufacturing of pharmaceutical products. You will learn about regulatory initiatives to improve the quality of solid dosage pharmaceutical manufacturing using PAT. No special technical background is required.

13 / Dec / 2021 - Monday

* Per Attendee $199

 

How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances

webinar-speaker   Carlos M Aquino

webinar-time   90 Min

Product Id: 705164

This training covers DEA record-keeping and security topics that a DEA registrant must comply with when handling controlled substances. The focus is elements of what occurs during that unannounced inspection and the auditing methods.

Recording Available

* Per Attendee $299

 

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703727

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.

Recording Available

* Per Attendee $299

 

Process Analytical Technology (PAT): The Impact on Pharmaceuticals Manufacturing and Validation Needs/Requirements

webinar-speaker   Michael Levin

webinar-time   60 Min

Product Id: 701147

This webinar will provide an insight into the practical aspects of the Process Analytical Technology (PAT) and will be an invaluable source of information on various technologies and approaches that fit the PAT definitions. You will learn about regulatory initiatives to improve the quality of pharmaceutical manufacturing using PAT and validation thereof. No special technical background is required.

Recording Available

* Per Attendee $299

 

 

 

How to Implement the FDA SUPAC Guidance

webinar-speaker   Michael Levin

webinar-time   60 Min

Product Id: 704312

This webinar training will cover various topics on Scale-Up and Post-Approval Changes (SUPAC). Participants will learn how to properly scale-up or scale-down pharmaceutical batch process and learn the standard set of documentation to successfully support post-approval changes.

Recording Available

* Per Attendee $299

 

How to Survive a DEA Inspection Series: For DEA Registered Analytical Labs and Research Facilities

webinar-speaker   Carlos M Aquino

webinar-time   90 Min

Product Id: 704617

The training program will cover DEA record-keeping requirements and effective security that a DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.

Recording Available

* Per Attendee $299

 

CGMP controlled Raw Materials

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 705148

This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.

Recording Available

* Per Attendee $399

 

Biosimilars in Europe: Pricing, Interchangeability and Policy

webinar-speaker   Peter Wittner

webinar-time   90 Min

Product Id: 706760

As far as biosimilars are concerned, Europe led the way and the rest of the world, including the US, followed - but how did this happen? The webinar will explain how Europe’s EMA developed the first regulatory environment that allowed multiple competitors to enter the market and start to take market share away from the originators. It also looks at the effect of the increased competition, the moves to include biosimilars in tenders, the resultant impact on prices, how the originators fought back and where we are now.

Recording Available

 

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 705783

This webinar will discuss various US and international regulatory requirements, testing requirements for environmental monitoring program, current air and surface monitoring for measurement of no-viable particulate, microbial contamination, contamination due to personnel (gowning techniques and aseptic practices), ongoing monitoring practices with reference to sampling frequency, sampling locations and investigation of action level excursions and monitoring data.

Recording Available

* Per Attendee $249

 

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 704659

The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.

Recording Available

* Per Attendee $299

 

Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats

webinar-speaker   Michael Esposito

webinar-time   90 Min

Product Id: 706067

Counterfeit drugs present a real and increasing danger both to patients and companies and require a proactive approach to stay ahead of them. This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.

Recording Available

 

The Importance of Packaging and Labeling in Pharmaceutical Product Development

webinar-speaker   Michael Esposito

webinar-time   60 Min

Product Id: 706063

Packaging and labeling is often underestimated in the planning phases of pharmaceutical product development. This leads to unnecessary increases in cycle time, costly errors, and delays in product availability, or product recalls due to noncompliance. This webinar will help you succeed in pharmaceutical product launch by exploring its importance right from the conception of a product, its realization and distribution.

Recording Available

* Per Attendee $299

 

Introduction to European Good Pharmacovigilance Practices: 4-hr Virtual Seminar

webinar-speaker   Miranda Dollen

webinar-time   4 Hrs

Product Id: 706466

This webinar is intended for the pharmaceutical industry and associated service providers. It will provide a robust introduction to Good Pharmacovigilance Practice (GVP) in the European Economic Area, reviewing all modules of the Guidelines on GVP published by the European Medicines Agency.

Recording Available

* Per Attendee $499

 

 

 

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